Evolution of the Treatment-Based Classification for Low Back Pain

The following is an article written for the online, video-based physical therapy continuing education company MedBridge

The prevalence and economic burden of low back pain (LBP) has reached an epidemic level and continues to put a strain on the U.S. healthcare system. According to Hoy et al, the overall incidence of LBP is between 1.5% and 36% with incidence of first-ever LBP ranging between 6.3-15.3%.

This is a HUGE proportion of the general population and typically makes up a large portion of the therapist’s daily caseload. Through the improvement of medical imaging, physicians are better able to see “what’s going on” inside an individual’s spine, but is this information helpful?

Is Medical Imaging the Answer?

The accuracy of the pathoanatomical model in diagnosing and treating LBP is severely overrated. Multiple imaging studies have proven this model is limited by the high rate of false-positives. For example, a study conducted by Savage et al found that 32% of asymptomatic individuals had ‘abnormal’ lumbar spines (as determined by MRI) and 47% of symptomatic individuals had no evidence of abnormality. Additionally, Jarvik and colleagues found no benefit with regards to patient self perceived disability when imaging was conducted early in their course of care. So, if medical imaging isn’t the answer, then how do we diagnose and treat these patients?

Treatment-Based Classification and Its Evolution

According to the Low Back Pain Clinical Guidelines published by Delitto et al, “The best available evidence supports a classification approach that de-emphasizes the importance of identifying specific anatomical lesions after red flag screening is completed.” Within the physical therapy community, there are several unique classification systems, but only one is backed by a substantial bounty of evidence. This Treatment-Based classification (TBC) system distinguishes 4 sub-groups of patients that are treated with specific interventions depending upon their classification. These sub-groups include:

This system was initially proposed by Delitto et al in 1995 and has evolved over the greater part of two decades. Below is a table created by Fritz et al presenting both both the original criteria and the revision proposed in 2007.

FritzTBC2007

Recently, the TBC approach to the management of low back pain underwent another revision in order to address several limitations that have come to light since its revision in 2007. Alrwaily et al recognized that the current system was lacking in addressing the biopsychosocial aspects of low back pain and that the categorization process was not efficient enough. In order to improve this system, the following areas were updated:
  1. Initial triage process includes all healthcare providers who come in first contact with patients with LBP in addition to the level of the rehabilitation provider
  2. Establishing decision-making criteria for the first contact practitioner to triage patients into one of three approaches: medical management, rehabilitation management, self-care management
  3. Utilizing risk stratification and psychosocial tools to determine which patients require psychologically informed rehabilitation
  4. The treatment based classification categories were broadened in order to prevent misclassification of patients

One of the largest issues with the 2007 TBC system proposed by Fritz et al was an inability to match patients to their appropriate treatment group. An evaluation by Stanton et al in 2011 determined that when a patient did not match a specific intervention, they were broadly lumped into the stabilization category or simply remained unclassified. In addition to this flaw, another study conducted by Stanton and colleagues found that close to 25% of patients met the criteria for at least two of the included treatment categories.

In order to address these limitations, Alrwaily and colleagues once again revised the classification system in 2015. This new system breaks the initial triage process into the level of the first healthcare provider contact (direct access) and rehabilitation provider. At the level of the first provider, the patient is directed either toward medical management, rehabilitation management, or self management. This determination is based on the presence/absence of red flags and neurological deficits. Once the patient has been transitioned to rehabilitation management, the classification categories have been broadened in order to direct patients toward the correct treatment approaches. Instead of breaking the categories into specific interventions, they are now broken into logical groups of interventions (symptoms modulation, movement control, and functional optimization). This alteration will prevent patients from being categorized into multiple groups or not being classified what so ever.

TBC2015

Treatment-Based Classification Yields Better Outcomes

In 2000, Fritz et al published a prospective cohort study looking at short-term patient outcomes after matching patient sub-groups to their corresponding treatment strategies. This study evaluated the outcomes of 120 patients receiving physical therapy for acute LBP. While Fritz’s initial evaluation of this treatment strategy did not compare its effects to standard care, it did give some preliminary support to its efficacy.

Later in 2003, Fritz et al conducted a randomized controlled trial of 78 patients comparing their treatment-based classification system to the current clinical guidelines for patients with acute LBP. Patients with work-related LBP of less than 3 weeks duration were admitted after being cleared of “red flags.”

Guideline Group

Subjects assigned to the Guideline Group (GG) were treated with low-stress aerobic exercise (treadmill walking or stationary cycling), general muscle reconditioning exercises, and advice was given to remain as active as possible within the limits of their pain.

Classification Group

Patients in the Classification Group (CG) were evaluated and assigned to the most appropriate sub-group. Following assignment, they were then treated based on the system proposed by Delitto et al.

Results

At 4 weeks, when compared to the GG, the CG had statistically significant mean improvements within group in:

  • Oswestry (22.5 v. 11.6),
  • SF-36 PCS (-13.6 v. -8.0)
  • Improved median satisfaction with treatment

At the one-year follow-up, mean Oswestry scores approached, but did not meet statistical significance (p= 0.063) in favor of the CG.

In terms of healthcare utilization, of the 20 patients who took up 51% of the total medical costs, 13 were from the GG and only 7 were from the CG. This translated into a relative risk of 2.1 for the guideline group and a number needed to treat of 5.5, or an average number of patients who need to be treated to avoid a ‘high cost’ patient when using the classification system compared to the clinical guideline approach.

Why It Works: Superior Interventions or the Matching Principle?

What if the interventions being provided from the previous clinical guideline standards were simply inferior to the techniques used by the classification group? Would proper pairing of presentation to treatment remain an important factor in outcomes when the same interventions were used throughout the patient population?

Brennan et al published a randomized controlled trial that investigated the impact of pairing interventions to the correct sub-group of patients with non-specific LBP. In evaluation of 123 patients, those individuals who were matched to the correct treatment approach demonstrated greater short- and long-term improvements in disability compared to those who were unmatched. Patients in the matched group achieved significantly greater improvements in mean Oswestry scores at 4 weeks (29.9 v. 23.3) and one year from baseline (33.3 v. 26.1).

Additionally, 78% of subjects in the matched group achieved progression to stage II of treatment, while only 60% of the unmatched patients achieved this milestone (p= 0.039). This study gave continued credence to the application of a treatment-based approach in the management of acute LBP.

Do the Outcomes Depend on a Clinician’s Experience?

The above studies give the treatment-based classification system solid evidence-based support, but is it reliable enough for widespread utilization by clinicians?

Fritz et al evaluated the inter-rater reliability of individual examination characteristics related to the treatment-based classification system in clinicians with varying levels of experience.

The evaluation included:

  • 10 ‘novice’ physical therapists (< 5 years of experience, no experience using the classification system)
  • 10 ‘experienced’ physical therapists (5+ years of experience, no experience using the system)
  • 10 ‘expert’ physical therapists (used the system clinically and participated in research involving the system)

Patients were evenly distributed to each clinician category with between 24-25 patients seen by each group. In terms of individual examination characteristics, the inter-rater reliability coefficients were at least moderate for all range of motion measurements, the prone instability test, and judgments of centralization/peripheralization with flexion and extension ROM. However, reliability of centralization/peripheralization with repeated or sustained extension movements and judgments of aberrant movements were fair or poor.

The ultimate agreement among clinicians on patient placement within the classification decision-making algorithm was 75.9%, which correlated to a kappa value of 0.60 (moderate agreement). Additionally, there was no significant difference in kappa value depending on experience of the examining therapist.

Earlier this year, Henry et al conducted a similar study with 12 therapists evaluating 24 total patients. This small cross-sectional reliability study produced total agreement on classification of 80.9% and a kappa value of 0.62 (moderate-good agreement), which agrees with the previous study by Fritz et al.

The Most Effective Evidence-Based Tool for Low Back Pain

This classification system has been rigorously evaluated and has come out with moderate to good inter-rater reliability regardless of clinician experience or expertise. This goes along with the improved clinical outcomes and decreased healthcare costs seen in two large randomized controlled trials. Currently, this is the most consistent and effective evidence-based tool to evaluate and treat LBP and should be considered a viable option for any therapist.

Additionally, as new evidence comes to light, the system continues to evolve in order to accommodate the growing body of evidence with regards to the evaluation and treatment of low back pain. During clinical practice, not every patient will fit nicely into a specific subgroup, but having this framework aids clinicians in making more informed, evidence-based treatment decisions.

Research Review: Comparison of 2 Manual Therapy and Exercise Protocols for Cervical Radiculopathy

In the next installment of the Research Review Series, we discuss a recent randomized controlled study investigating the effectiveness of a manual therapy program specifically tailored to increase the intervertebral foramen (IVF) versus a general manual therapy program in patients presenting with cervical radiculopathy3.

Study Design

Participant and assessor blinded randomized clinical trial.

Subjects

Thirty-six subjects were included in the study following inclusion/exclusion criteria (18 in both the experimental and control group). There were no significant differences between groups with regards to age (47.8 v. 42.8), weight (76.3 kg v. 80.9 kg), symptom duration (5.7 weeks v. 5.4), NDI (32.0 v. 34.8), Quick DASH (42.3 v. 42.8), Cervical NPRS (4.1 v. 4.3), Upper Limb NPRS (4.6 v. 4.8), or Cervicothoracic mobility.

Inclusion Criteria: (1) between 18 and 65 years of age, (2) pain, paresthesia, or numbness in 1 upper limb, with cervical or periscapular pain of less than 3 months in duration, (3) at least 1 neurological sign of a lower motor neuron lesion in a cervical spine nerve root or spinal nerve, and (4) positive responses to at least 3 of the 4 clinical tests in the Clinical Prediction Rule proposed by Wainner et al4.

Exclusion Criteria: (1) prior surgery to the cervicothoracic spine, (2) bilateral symptoms, (3) signs of upper motor neuron impairments, (4) cervical spine injection in the previous 4 weeks, (5) current use of steroidal anti-inflammatory drugs, or (6) financial compensation for the cervical condition.

Methods

Outcome Measures: Neck Disability Index (NDI), Shortened Version of the Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH), Cervical Numeric Pain-Rating Scale (CNPRS), Upper Limb Numeric Pain-Rating Scale (ULNPRS), and Cervicothoracic Mobility utilizing the CROM device.

Randomization: An independent research assistant not involved in data collection generated a randomization list prior to the start of the study, using a random-number generator. Group allocations were concealed in sealed, opaque, sequentially numbered envelopes, and blocked randomization was used to make sure that two equal groups were obtained. The two programs were given in different clinics and the evaluation sessions took place outside the treating clinics in order to reduce potential contamination bias.

Interventions: Each patient received treatment sessions during a 4-week period and performed a home exercise program. The patients in the Control Group (CG) received 4 manual therapy techniques at each treatment session. The manual therapy techniques were chosen by the physical therapist according to the results of the biomechanical examination, but could not be used to specifically increase the affected IVF. These techniques could be cervical rotations, lateral glides in neutral, posteroanterior glides, posteroinferior medial glides, or anterosuperior anterior glides. Each manual therapy technique was performed for 10 repetitions of 30 seconds, with a force grade of 3 to 4. Following the mobilization techniques, a 5-minute global (nonspecific) static manual cervical traction was applied. In addition to the manual therapy program, a home exercise program was also included, but none of the exercises could be used to specifically increase the IVF.

Contrary to the CG, the Experimental Group (EG) utilized interventions that were supposed to directly influence the IVF in order to treat the symptoms of cervical radiculopathy. Of the 4 mobilization techniques used at each treatment session, 2 were mandatory techniques thought to increase the size of the IVF on the same side and at the same presumed level as the radiculopathy (global contralateral rotation mobilization and ipsilateral lateral glide in a flexed position). Additionally, the third exercise of the HEP was a repeated movement that is known to increase the size of the IVF (cervical spine rotation in the direction contralateral to the affected side, performed for 10 repetitions, 10 times per day).

Results

Both groups showed significant improvement in NDI, QuickDASH, CNPRS, ULNPRS scores from baseline to week 4 and to 8 weeks. With regards to cervicothoracic mobility, both groups had significant improvement in cervical extension and side-bending. With these improvements, there was no significant group-by-time interaction found between the two groups in any of the measures. In agreement with this finding, the proportion of success did not significantly differ between groups at week 4 or at week 8.

Limitations

The most significant limitation in this study is the lack of a true control group, which received “standard treatment” (i.e. a non-manual therapy group). Secondly, the only outcome measure that was adequately powered based on sample size was the primary outcome of NDI score.

Clinical Implications

According to a systematic review conducted by Boyles et al.1, the use of manual therapy (muscle energy techniques, non-thrust/thrust manipulation/mobilization of the cervical and/or thoracic spine, soft-tissue mobilization, and neural mobilization) in addition to therapeutic exercise is effective in regards to increasing function, as well as AROM, while decreasing levels of pain and disability. However, often times, addressing a painful condition with a patho-anatomical approach is inadequate. As is demonstrated in this study, manual therapy in addition to a HEP provides decreased pain and improved function in the short-term and long-term, but the specific technique does not matter for cervical radiculopathy in general. This is where a patient response or bio-psychosocial approach should be utilized in order to drive treatment interventions/techniques instead of pathology-specific interventions. By utilizing an approach to identify and treat the patient’s comparable sign2, each patient’s complaints will be addressed without relying on the variable results of a patho-anatomical based treatment.

References

  1. Boyles R, et al. Effectiveness of manual physical therapy in the treatment of cervical radiculopathy: a systematic review.Journal of Manual and Manipulative Therapy. 2011; 19(3): 135-142.
  2. Cook CE, et al. The relationship between chief complaint and comparable sign in patients with spinal pain: An exploratory study. Manual Therapy. 2015 [Epub Ahead of Print]
  3. Langevin P, Desmeules F, Lamothe M, Robitaille S, Roy J-S. Comparison of 2 Manual Therapy and Exercise Protocols for Cervical Radiculopathy: A Randomized Clinical Trial Evaluating Short-Term Effects. Journal of Orthopaedic & Sports Physical Therapy. 2015; 45(1): 4–17. doi:10.2519/jospt.2015.5211.
  4. Wainner CR, et al. Reliability and Diagnostic Accuracy of the Clinical Examination and Patient Self-Report Measures for Cervical Radiculopathy. Spine. 2003;28(1):52–62.

The Most Important Aspect of Patient Care

The following is an article written for the online, video-based physical therapy continuing education company MedBridge

Helping individuals with a chronic pain and significant functional limitations is a remarkably difficult and delicate task. Numerous treatment philosophies are available to clinicians from the overtly biomechanical (Cyriax, Kaltenborn, Sahrmann, etc.) to more patient-response driven (Maitland, Mckenzie, etc.). Unfortunately, no one approach has been proven superior to others. For instance, in one of the only comparison studies, Powers and colleagues1 investigated the acute effects of a common Maitland intervention (posterior-to-anterior mobilization) to a common McKenzie intervention (prone press-up) on patients with non-specific low back pain. The study concluded that both groups improved significantly in pain level and lumbar extension, but without significant differences between the two interventions.

If the approach isn’t the determining factor, what makes one clinician better than another?

Throughout my clinical education and professional career, I have been exposed to expert clinicians with varying interventions, personalities, and clinical reasoning. However, one aspect holds true for all the clinicians who achieve superior outcomes – they form a positive therapeutic alliance (TA) with their patients.

What is a therapeutic alliance?

Leach et al.2 defines a therapeutic alliance as “a trusting connection and rapport established between therapist and client through collaboration, communication, therapist empathy and mutual understanding and respect”. Moreover, a TA involves working together to define goals and success criteria for the treatment. With trust and mutual understanding, your patients are more confident in the interventions and more positive in their expectations from the treatment, which goes a long way towards achieving positive outcomes3. While every patient and pathology is unique, your patients deserve for a positive TA to be integrated and nurtured within their care.

Is there evidence supporting the importance of a therapeutic alliance?

Quite a bit of literature links a trusting therapeutic relationship to superior patient outcomes. A recent systematic review found that amongst patients with musculoskeletal complaints a positive therapeutic alliance was associated with significant improvements in the patient outcomes, including global perceived effect of treatment and satisfaction with treatment, pain levels, physical function, depression, and general health status4. More recently several randomized controlled trials have found favorable associations between positive alliance and outcomes in patients with chronic low back pain.

Fuentez et al.5 investigated how varying levels of therapeutic alliance impact a single-session treatment of chronic low back pain when combined with interferential electrical stimulation. They found significant improvements when patients received enhanced TA as opposed to limited TA. In a randomized controlled trial, Ferreira and colleagues6 looked into the effect of TA as part of a longer-term treatment with a follow-up at 8 weeks. Once again, therapeutic alliance had a significant influence on patient outcomes. The therapeutic alliance at baseline was a nonspecific predictor for the 4 measures of treatment outcome (global perceived effect, pain, disability, function) regardless of intervention applied by the treating therapist (motor control, general exercise, or spinal manipulative therapy). These two studies give further credence for the importance of forming mutual collaboration and trust with your patients.

Sometimes, techniques or interventions we use play a lesser role than our relationship with the patient. Many therapists downplay one approach in lieu of their chosen technique or approach, however no one approach is effective or ineffective for all patients. Only one aspect of patient care – therapeutic alliance – translates to each and every patient.

References:

1. Powers CM, Beneck GJ, Kulig K, Landel RF, Fredericson M. Effects of a single session of posterior-to-anterior spinal mobilization and press-up exercise on pain response and lumbar spine extension in people with nonspecific low back pain. Phys Ther. 2008; 88(4): 485-93. doi: 10.2522/ptj.20070069.

2. Leach, Matthew J. Rapport: A key to treatment success. Complementary Therapies in Clinical Practice. 2005; 11(4): 262 – 265.

3. Joel E Bialosky, Mark D Bishop, Michael E Robinson, Josh A Barabas and Steven Z George. The influence of expectation on spinal manipulation induced hypoalgesia: An experimental study in normal subjects. BMC Musculoskeletal Disorders. 2008; 9-19 doi:10.1186/1471-2474-9-19.

4. Hall AM, Ferreira PH, Maher CG, Latimer J, Ferreira ML. The influence of the therapist-patient relationship on treatment outcome in physical rehabilitation: a systematic review. Phys Ther. 2010; 90(8): 1099-110. doi: 10.2522/ptj.20090245.

5. Fuentes J, Armijo-Olivo S, Funabashi M, Miciak M, Dick B, Warren S, Rashiq S, Magee DJ, Gross D. Enhanced therapeutic alliance modulates pain intensity and muscle pain sensitivity in patients with chronic low back pain: an experimental controlled study. Phys Ther. 2014; 94(4): 477-89. doi: 10.2522/ptj.20130118.

6. Ferreira PH1, Ferreira ML, Maher CG, Refshauge KM, Latimer J, Adams RD. The therapeutic alliance between clinicians and patients predicts outcome in chronic low back pain. Phys Ther. 2013; 93(4): 470-8. doi: 10.2522/ptj.20120137.

Research Review: Validation of a Clinical Prediction Rule to Identify Patients with LBP Likely to Respond to Stabilization Exercises

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In the next instalment of my Research Review Series for MedBridge Education, we discuss a recent randomized controlled study investigating the validity of a clinical prediction rule for identifying patients with low back pain likely to respond favoribly to a spinal stabilization program.

Study Design

Randomized Controlled Trial.

Subjects

One hundred five patients diagnosed with LBP and referred to physical therapy at 1 of 5 outpatient clinics of Clalit Health Services in the Tel-Aviv metropolitan area, Israel, were recruited for this study. Of these 105 patients, 40 were positive on the Stabilization CPR and 65 were negative. The most evident difference between baseline differences of groups was age, with those in the stabilization group being significantly younger (one of the items of the CPR is < 40 years old).

Inclusion Criteria: 18 to 60 years of age, primary complaint of LBP with or without associated leg symptoms (pain, paresthesia), and had a minimum score of 24% on the Hebrew version of the modified Oswestry Disability Index (MODI) outcome measure.

Exclusion Criteria: History indicating any red flags (malignancy, infection, spine fracture, cauda equina syndrome), 2 or more signs suggesting lumbar nerve root compression (decreased deep tendon reflexes, myotomal weakness, decreased sensation in a dermatomal distribution, or a positive SLR, crossed SLR, or femoral nerve stretch test), history of corticosteroid use, osteoporosis, or rheumatoid arthritis. Additionally, patients were excluded if they were pregnant, received chiropractic or physical therapy care for LBP in the preceding 6 months, could not read or write in the Hebrew language, or had a pending legal proceeding associated with their LBP.

Methods

Outcome Measures: Hebrew version of the modified Oswestry Disability Index (MODI) and Numerical Pain Rating Scale (NPRS).

Randomization: Based on a computer-generated list of random numbers, which was then stratified by CPR status to ensure that adequate numbers of patients with a positive and a negative CPR status would be included in each intervention group.

Evaluation: A physical examination was conducted that included a neurological screen to rule out lumbar nerve root compression. Next, lumbar active motion was evaluated, during which the presence of aberrant movement, as defined by Hicks et al, was determined. Bilateral SLR range of motion, segmental mobility of the lumbar spine, and the prone instability testing was then also conducted. The patients’ status on the CPR (positive or negative) was established based on the findings of the physical examination.

Interventions: Patients in both the Lumbar Stabilization Exercise group (LSE Group) and Manual Therapy group (MT) received 11 treatments over an 8 week period and a 12 visit, which consisted of solely a re-evaluation. The LSE group was first educated on the function and common impairments related to the lumbar stabilizing musculature, they were then taught to perform an isolated contraction of the transversus abdominis and lumbar multifidus through an abdominal drawing-in maneuver (ADIM) in the quadruped, standing, and supine positions. Once the patient could successfully perform these actions, the demands on the musculature were increased by the addition of various upper and lower extremity movements. Finally, during the seventh session, functional movements were added to their program. Those patients randomized to the MT group received several thrust and non-thrust mobilization techniques to their lumbar spine in addition to manual stretching of several hip and thigh muscle groups. Each treatment session included up to three manual techniques (one of which had to be a thrust technique). With regards to exercise, those in the MT group performed active range of motion and self-stretching exercises, but did not perform isolated spinal stabilization exercises. All variations and progressions of exercises and manual therapy techniques can be seen in the appendix of the research report.

Results

With regards to MODI, clinical significance could not be determined after 2-way interaction between treatment group and CPR status was calculated (p = 0.17). That being said, individuals who were positive on the CPR did demonstrate less disability at the end of the study compared to those who were negative (p = 0.02). Furthermore, amongst patients who were positive on the CPR, those who received LSE also demonstrated less disability following treatment compared to those who received MT. When the authors introduced a modified CPR, which consisted of positive prone instability test and presence aberrant movement, they did find a significant interaction with treatment for final MODI. Those positive on the modified CPR demonstrated superior outcomes compared to the group as a whole and also showed improved outcomes when receiving LSE compared to MT (p = 0.005).

Limitations

The most prevalent limitations include an inadequate sample size, which resulted in a limited overall power of the findings as well as the retrospective nature of some of the findings (i.e. modified CPR). Additionally, this study had a high drop-out rate for a study of its size with an overall drop-out rate of 22.8% (33% in the LSE group and 14% in the MT group). The lower dropout rate in the MT group could potentially be due to an attention affect due to the manual contact required for the interventions within this group compared to the LSE group. Additionally, while short-term results are important, understanding the long-term implications of either MT or LSE is of greater importance. This study only included an 8 week follow-up and it would be beneficial to see the long-term implications with a 6 or 12 month follow-up to gauge the overall effectiveness of the CPR and associated interventions. Finally, it should be noted that status on CPR was determined prior to group determination, which introduces an additional level of bias. Future studies should look at results with CPR determination post priori or following allocation to groups.

Clinical Implications

Manual therapy and spinal stabilization are two very common interventions utilized by physical therapists when treating low back pain. As manual therapy is common amongst clinicians and generally considered an effective treatment option, it provides an excellent reference value in the validation of the stabilization CPR. Unfortunately, the utility of the CPR as it was constructed could not be validated based on the findings of this study. Several factors could have played into this discrepancy including attention effect by those in the MT group, small sample size, and large dropout percentage. While the original CPR could not be validated, retrospectively an abbreviated CPR was identified and ‘validated’ based on the findings of the 2-way interaction between treatment group and modified CPR status. So, while this study seems like a knock to the current lumbar stabilization CPR, the study design and execution of the study cannot allow the CPR to be disregarded as all of the aforementioned limitations may have played a significant role in the study’s results. Additionally, the creation of an abridged CPR may have more value to clinicians long-term as it provided superior results and requires less factors to be evaluated by the clinician. However, the results must be taken with a grain of salt as a prospective evaluation of the modified CPR must be conducted in order to determine its utility. Clinical prediction rules and the effectiveness of spinal stabilization are polarizing issues within the physical therapy community and this study debatably provides support to the use of spinal stabilization and indicates that future research is needed to clear up the murkiness of the current stabilization CPR. When treating the lumbar spine, no treatment should be provided with every patient and Chad Cook, PT, PhD, FAAOMPT goes into great detail in his course, “Evidence-Based Treatment of the Lumbar Spine”, with regards to the use of spinal stabilization within the Treatment-Based Classification system.

Rabin A, Shashua A, Pizem K, Dickstein R, Dar G. A Clinical Prediction Rule to Identify Patients With Low Back Pain Who Are Likely to Experience Short-Term Success Following Lumbar Stabilization Exercises: A Randomized Controlled Validation Study. Journal of Orthopaedic & Sports Physical Therapy. 2014; 44(1): 6–18, B1–13. 

Neck Pain Best Practice: Treatment-Based Classification

The following is another article written for the online, video-based physical therapy continuing education company MedBridge Education

Among one of the most common musculoskeletal complaints, neck pain has been estimated to effect between 22% and 77% of individuals in their lifetime according to the Neck Pain Clinical Practice Guidelines published by Childs et al. While this pain is typically self-limiting and resolves with time, Bovim et al found that 30% of patients reporting neck pain will ultimately develop chronic symptoms of greater than 6 months in duration. In addition to this study, researchers also found that between 37% (Cote et al) and 44% (Hurwitz et al) of those who experience neck pain will report lingering symptoms for at least 12 months. Unfortunately, even after successful treatment, there has been a reported recurrence rate of 50-85% within the first 1-5 years following resolution of symptoms (Halderman et al). Neck pain is multi-factorial in nature with patients reporting varying symptoms depending on pathology, psychosocial influences/fear-avoidance, and age. Because of the varying clinical presentations of this particular group of patients, an individualized treatment plan developed based on their specific impairments/symptoms should be implemented.

The primary goal of classification is to determine the treatment approach most likely to yield the best clinical outcome for an individual patient and secondarily to determine the patient’s appropriateness for physical therapy. Taking after the treatment-based classification system proposed by Delitto et al for low back pain, Childs et al developed a similar system for disorders of the cervical spine. The first step in this classification scheme is determining the patient’s appropriateness for physical therapy. In general, this stage encompasses screening for ‘red flags’ (cervical myelopathy, cancer, ligamentous instability, fracture, and vascular compromise) as well as non-musculoskeletal causes of neck pain (i.e. cardiac event). This preliminary stage of the process is integral in ruling out significant pathology that needs further radiological imaging and/or surgical intervention prior to beginning a course of physical therapy. During this stage, two specific clinical prediction rules (CPR) can be utilized in order to improve your ability to make the best clinical judgment in this important preliminary stage in the examination process (Cervical Myelopathy and Fracture). After successfully clearing your patient from the presence of serious pathology, the patient’s psychosocial profile should be screened for the presence of any ‘yellow flags’ that may alter your treatment approach (catastrophizing, high fear-avoidance beliefs, ect.). These patients may benefit from a graded exercise, graduated exposure, and/or a pain science education approach in conjunction with the treatment-based classification system groupings.

The final stage of this classification scheme involves determining the correct treatment category for the patient based on their clinical presentation. The classification system for neck pain can be broken into 5 distinct categories (Mobility, Centralization, Exercise & Conditioning, Pain Control, and Headache). The Mobility group receives cervical and/or thoracic manipulative and mobilization interventions in conjunction with cervical exercises (active range of motion, deep cervical flexors, ect.). Identifying these patients can be improved by implementing the CPR for cervical manipulation and the CPR for thoracic manipulation in addition to your clinical expertise and the criteria proposed by Childs et al. Those in the centralization group should receive interventions to create centralization of their symptoms either through the use of their specific directional preference via repeated movements or through the use of manual/mechanical cervical traction. Furthermore, the identification of individuals who will specifically benefit from cervical traction can be aided through the use of the CPR developed by Raney et al. Patients who will benefit from general conditioning and exercise typically display lower pain/disability scores and have a longer duration of symptoms and benefit from targeted strengthening and endurance interventions to improve muscular imbalances and/or deficits. The pain control grouping consists of non-aggravating manual techniques, therapeutic modalities, and activity modification. However, the patient should be progressed to a more active classification category as soon as tolerated. Finally, the headache group is treated with manual therapy techniques directed at the cervical and thoracic spine (manipulation, sub-occipital release, ect.) in addition to upper extremity strengthening. As stated in Chad Cook, PT, PhD, MBA, FAAOMPT’s course, “Manual Therapy for the Cervical Spine: An Evidence-Based Approach”, the process of classification is ongoing, and it is assumed that a patient’s presentation will change with time and treatment. Due to this continual change in presentation, ongoing reassessment is required in order to determine the most appropriate sub-group and subsequent intervention at any point in time during the patient’s course of treatment.

While this is a relatively new classification system, there is some evidence available supporting its effectiveness. In 2007, Fritz et al performed a preliminary investigation into the utility of this particular treatment approach. Baseline patient characteristics and evaluations were performed on 274 patients and subjects were split into two groups (those matched to their classification group and those unmatched). Overall, 113 patients received matched interventions and 161 patients received unmatched interventions. Patients receiving matched interventions showed greater changes in both Neck Disability Index (NDI) scores and pain rating scores compared to their unmatched counterparts. Additionally, 72.5% of patients in the matched group achieved the minimal detectible change in NDI, whereas those in the unmatched group only achieved this feat in 53.8% of patients. Along with this outcome data, the authors found a kappa value of 0.95 for classification determination and 0.96 for the treatment matching decision, both of which are in very strong agreement. In conjunction with this randomized controlled trial, Heintz and Hegedus published a case report of a patient presenting with mechanical neck pain who was successfully treated with the aforementioned treatment-based classification system. Over this patient’s 6-week treatment (38 days), pain was reduced from 4-10/10 to 0/10 with only a complaint of stiffness at end-range and their NDI score decreased from 52% (severe disability) to 6% (no disability). Obviously, this is only one patient, but it does add evidence to the effectiveness of this particular treatment approach. While the research regarding this treatment approach is in its infancy, the current evidence available provides preliminary support to its effectiveness in treating patients presenting with mechanical neck pain.

Research Review: Validation of a Clinical Prediction Rule to Identify Patients with LBP Likely to Respond to Stabilization Exercises

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Study Design

Randomized Controlled Trial.

Subjects

One hundred five patients diagnosed with LBP and referred to physical therapy at 1 of 5 outpatient clinics of Clalit Health Services in the Tel-Aviv metropolitan area, Israel, were recruited for this study. Of these 105 patients, 40 were positive on the Stabilization CPR and 65 were negative. The most evident difference between baseline differences of groups was age, with those in the stabilization group being significantly younger (one of the items of the CPR is < 40 years old).

Inclusion Criteria: 18 to 60 years of age, primary complaint of LBP with or without associated leg symptoms (pain, paresthesia), and had a minimum score of 24% on the Hebrew version of the modified Oswestry Disability Index (MODI) outcome measure.

Exclusion Criteria: History indicating any red flags (malignancy, infection, spine fracture, cauda equina syndrome), 2 or more signs suggesting lumbar nerve root compression (decreased deep tendon reflexes, myotomal weakness, decreased sensation in a dermatomal distribution, or a positive SLR, crossed SLR, or femoral nerve stretch test), history of corticosteroid use, osteoporosis, or rheumatoid arthritis. Additionally, patients were excluded if they were pregnant, received chiropractic or physical therapy care for LBP in the preceding 6 months, could not read or write in the Hebrew language, or had a pending legal proceeding associated with their LBP.

Methods

Outcome Measures: Hebrew version of the modified Oswestry Disability Index (MODI) and Numerical Pain Rating Scale (NPRS).

Randomization: Based on a computer-generated list of random numbers, which was then stratified by CPR status to ensure that adequate numbers of patients with a positive and a negative CPR status would be included in each intervention group.

Evaluation: A physical examination was conducted that included a neurological screen to rule out lumbar nerve root compression. Next, lumbar active motion was evaluated, during which the presence of aberrant movement, as defined by Hicks et al, was determined. Bilateral SLR range of motion, segmental mobility of the lumbar spine, and the prone instability testing was then also conducted. The patients’ status on the CPR (positive or negative) was established based on the findings of the physical examination.

Interventions: Patients in both the Lumbar Stabilization Exercise group (LSE) and Manual Therapy group (MT) received 11 treatments over an 8 week period and a 12 visit, which consisted of solely a re-evaluation. The SG group was first educated on the function and common impairments related to the lumbar stabilizing musculature, they were then taught to perform an isolated contraction of the transversus abdominis and lumbar multifidus through an abdominal drawing-in maneuver (ADIM) in the quadruped, standing, and supine positions. Once the patient could successfully perform these actions, the demands on the musculature were increased by the addition of various upper and lower extremity movements. Finally, during the seventh session, functional movements were added to their program. Those patients randomized to the MT group received several thrust and non-thrust mobilization techniques to their lumbar spine in addition to manual stretching of several hip and thigh muscle groups. Each treatment session included up to three manual techniques (one of which had to be a thrust technique). With regards to exercise, those in the MT group performed active range of motion and self stretching exercises, but did not perform any exercises that included significant activation of the trunk musculature. All variations and progressions of exercises and manual therapy techniques can be seen in the appendix of the research report.

Results

With regards to MODI, clinical significance could not be determined after 2-way interaction between treatment group and CPR status was calculated (p = 0.17). That being said, individuals who were positive on the CPR did demonstrate less disability at the end of the study compared to those who were negative (p = 0.02). Furthermore, amongst patients who were positive on the CPR, those who received LSE also demonstrated less disability following treatment compared to those who received MT. When the authors introduced a modified CPR, which consisted of positive prone instability test and presence aberrant movement, they did find a significant interaction with treatment for final MODI. Those positive on the modified CPR demonstrated superior outcomes compared to the group as a whole and also showed improved outcomes when receiving LSE compared to MT (p = 0.005).

Limitations

The most prevalent limitations include an inadequate sample size, which resulted in a limited overall power of the findings and the retrospective nature of some of the findings (i.e. modified CPR). Additionally, this study had a high drop-out rate for a study of its size with an overall drop-out rate of 22.8% (33% in the LSE group and 14% in the MT group). The lower dropout rate in the MT group could potentially be due to an attention affect due to the manual contact required for the interventions within this group compared to the LSE group. Finally, while short-term results are important, understanding the long-term implications of either MT or LSE. This study only included an 8 week follow-up and it would be beneficial to see the long-term implications with a 6 or 12 month follow-up to gauge the overall effectiveness of the CPR and associated interventions.

Clinical Implications

Manual therapy and spinal stabilization are two very common interventions utilized by physical therapists when treating low back pain. As manual therapy is common amongst clinicians and generally considered an effective treatment option, it provides an excellent reference value in the validation of the stabilization CPR. Unfortunately, the utility of the CPR as it was constructed could not be validated based on the findings of this study. Several factors could have played into this discrepancy including attention effect by those in the MT group, small sample size, and large drop-out percentage. While the original CPR could not be validated, retrospectively a abbreviated CPR was identified and ‘validated’ based on the findings of the 2-way interaction between treatment group and modified CPR status. So, while this study seems like a knock to the current lumbar stabilization CPR, the study design and execution of the study cannot allow the CPR to be disregarded as all of the aforementioned limitations may have played a significant role in the study’s results. Additionally, the creation of an abridged CPR may have more value to clinicians long-term as it provided impressive results and requires less factors to be evaluated by the clinician. However, the results must be taken with a grain of salt as a prospective evaluation of the modified CPR must be conducted in order to determine its utility. Clinical prediction rules and the effectiveness of spinal stabilization are polarizing issues within the physical therapy community and this study debatably provides support to the use of spinal stabilization and future direction needed to clear up the murkiness of the current stabilization CPR.

Rabin A, Shashua A, Pizem K, Dickstein R, Dar G. A Clinical Prediction Rule to Identify Patients With Low Back Pain Who Are Likely to Experience Short-Term Success Following Lumbar Stabilization Exercises: A Randomized Controlled Validation Study. Journal of Orthopaedic & Sports Physical Therapy. 2014; 44(1): 6–18, B1–13. 

Research Review: Effect of Manual Therapy on Vertebral and Internal Carotid Blood Flow

In the next installment of my Research Review series for MedBridge Education, we will discuss a recent study that appeared in Physical Therapy Journal conducted by Thomas et al. The authors investigated the changes in vertebral and internal carotid blood flow during selective positions that are commonly associated with manual therapy techniques were assumed. This study provides additional evidence toward understanding the role of neck position on blood inflow to the brain.

Study Design

Experimental, observational magnetic resonance imaging (MRI) study.

Subjects

Twenty participants (10 male, 10 female) with a mean age of 33.1 years were recruited into the study. All participants had normal anatomy of their craniocervical arterial circulation, however three participants (15%) had dominance of one vertebral artery.

Inclusion Criteria: Healthy subjects, between the ages of 18 and 65 years old, no reported mechanical neck pain or headache.

Exclusion Criteria: Diagnosed inflammatory joint disease, any history of serious cervical spine trauma (i.e. fractures), any congenital disorder recognized as being associated with hypermobility or instability of the upper cervical spine, diagnosed vertebrobasilar artery insufficiency (VBI), claustrophobia or discomfort in confined spaces (standard contraindication for MRI), and any contraindication identified by the local health authority MRI safety screening questionnaire.

Methods

Experimental Conditions: While the MRI was being performed, the patients’ cervical spine was positioned in 9 distinctly different positions that simulate positions used in manual therapy techniques. These positions included: neutral position, left rotation, right rotation, left rotation with distraction, right rotation with distraction, left rotation localized to C1–C2, right rotation localized to C1–C2, distraction, and post-test neutral.

Outcome Measures: Blood flow in craniocervical arteries was measured with MRI using a phase-contrast flow quantification sequence. The arterial plane of section was selected to intersect the top of the atlas loop of the vertebral arteries at the level of the C1 vertebra, with imaging extending to just below the atlas loop. Average blood flow volume measured in milliliters per second was used as the primary test variable and was analyzed in neutral and each of the neck positions for each artery. The average blood flow volume in each artery then was compared between the neutral position and each of the experimental neck positions. Additionally, total blood supply to the brain was determined from the sum of average flow volume (mL/s) in both vertebral and both internal carotid arteries. A meaningful difference between the neutral position and any of the experimental conditions was determined to be > 10%.

Results

Average inflow to the brain in neutral was 6.98 mL/s and was not significantly changed by any of the test positions. According to the data collected, the lowest total blood inflow level was recorded during left rotation (6.52 mL/a). There was no significant difference in flow in any of the 4 arteries in any position from neutral, despite large individual variations. Although mean values of average flow volume were not significant for any position, there were certain individuals with marked flow changes in some positions. Flow generally decreased slightly for both the end-range rotation and distraction positions but increased in the other positions in comparison to neutral. Flow changes were all less than 10%, which is considered to be the normal variation for cerebral inflow.

Limitations

Secondary to restraints of the MRI and positioning of patients, full end-range rotation may not have been achieved. Additionally, some of the hand positions had to be altered from typical manual therapy techniques due to the constraints of the MRI set-up. None of the tested positions also included the thrust manipulation commonly used concurrently during a manual therapy procedure. Most notably, the results of this study should be cautioned as no subjects were included that presented with neck pain and/or headache symptoms.

Clinical Implications

Cervical manipulation is a polarizing topic amongst physical therapists and healthcare professionals as a whole. Many believe the risks are not worth the clinical benefits it provides to individuals suffering from mechanical neck pain. This study investigated blood flow to the brain during positions commonly associated with manipulative techniques and found only marginal changes in blood flow with multiple positions. What this study is not able to do (and wasn’t designed to do) is confirm the utility of positional tests for identifying those with blood flow restrictions or confirm that cervical thrust procedures do not involve blood flow changes (the subjects were healthy and there was no thrust used in this study). This sophisticated study adds nicely to the literature but clinicians still face the conundrum of identifying who may and my not be at risk during a thrust manipulation. Prior to intervening with cervical manipulative techniques, clinicians are urged to follow a thorough evaluation framework similar to that proposed by Flynn et al and the International Federation of Orthopaedic Manipulative Physical Therapists. Cervical manipulation should be implemented with caution and following a thorough subjective and physical examination when indicated by individual patient presentation.

Thomas LC, Rivett DA, Bateman G, Stanwell P, Levi CR. Effect of Selected Manual Therapy Interventions for Mechanical Neck Pain on Vertebral and Internal Carotid Arterial Blood Flow and Cerebral Inflow. Physical Therapy. 2013; 93(11): 1563–1574.