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.

Research Review: Immediate Effects of Real-Time Feedback on Jump-Landing Kinematics

In the next instalment of the Research Review Series, we discuss the impact of real-time feedback in addition to post-response feedback compared to post-response feedback alone on jumping-landing mechanics in a young female population1

Study Design

Randomized controlled trial.

Subjects

Thirty-six pain-free females were recruited from the general student population at the University of Toledo and assigned to either the real-time feedback (RTF), RTF plus post-response feed-back (RTF+), or the no feedback control group (CG).

Inclusion Criteria: (1) Female gender, (2) No current or previous lower extremity musculoskeletal complaints

Exclusion Criteria: (1) Male gender, (2) previous history of fracture, surgery, or significant orthopaedic injury to the lower extremity

Methods

Outcome Measures: Kinematic and kinetic data were collected as participants performed 3 trials of a jump-landing task from a 30-cm box, positioned at a horizontal distance of 50% of the participant’s height from 2 force platforms. Sagittal plane moments and angles at the knee and hip, frontal plane angles at the knee, and vertical ground reaction forces during the jump-landing task were quantified at baseline and post-intervention.

Randomization: Block randomization was used with concealed allocation to assign participants to 1 of the 3 groups. An opaque envelope was used to conceal group assignment until after baseline testing.

Interventions: Prior to the intervention, both the RTF+ and PRF feedback groups were presented with a PowerPoint presentation explaining the goals of the jump-landing task. This presentation outlined the need to (1) land with both feet at the same time, (2) land in neutral valgus/varus position, (3) land with feet shoulder width apart, (4) land on toes and rock onto heels, (5) land with increased bending at the knees and hips, and (6) land softly. After viewing the presentation, participants in both intervention groups performed 3 sets of 6 jumps from the box. Following each set of 6 jumps, the investigator reviewed the goals that the participant failed to accomplish in the previous jumps and showed the participant the corresponding PowerPoint slides to reinforce the correct form.

For the RTF+ group, participants received a live, digital representation of their body segments and were able to see a reference line to assist in making biomechanical corrections in the frontal plane. The RTF+ group was provided the following explanation,

You will now be able to see markers representing your knee and toe on the screen in real time; start with your toe marker in line with the reference line and then line your knee marker up with the reference line. This is the way the markers should line up when you land; we want you to watch the video monitor, focusing on keeping the shank segment in line with the reference line when you land from your jump. You can aim to land with your foot on the tape line, but your main focus should be to keep the shank segment lined up with the line when landing from the jump.

Participants in the no-feedback control group performed the same jump landing sequence as the other two groups, however they received no feedback or PowerPoint presentation on the major goals of jump landing.

Results

Post hoc testing revealed that the RTF+ and PRF groups had a greater increase in knee flexion, hip flexion, and greater decrease with regards to vertical ground reaction forces compared to the control group, but no differences were found between the two groups. Neither the RTF+ or PRF groups demonstrated a significant change in the knee extensor moment, hip extensor moment, or knee abduction angle post-intervention.

Limitations

This study had several significant limitations that may have impaired the impact of the interventions provided. First of all, there was no “pre-screening” for excessive valgus and due to this fact, the included subjects had very low knee abduction angles at baseline. This limited the ability to make any kind of meaningful impact post-intervention. This is where utilizing a simple lower extremity functional test would have aided in providing a better patient population. Additionally, this study only measured immediate impact of the interventions without looking into long-term retention of the movement pattern, which would be more important in injury risk reduction. With a fairly small, albeit adequately powered, sample-size, the statistical significance of some of the changes may have been hampered.

Clinical Implications

Anterior cuciate ligament injuries have significantly increased from 40.9 to 47.8 per 10,000 patients according to a study looking into trends and demographics of ACL injuries in the United States4. This rising incidence coupled with very high re-injury rates to the contralateral and ipsilateral limb3,5,6 make developing injury risk reduction programs paramount. Due to its importance, several researchers have investigated faulty movement patterns and the incidence of ACL injury. These studies have identified prospective evidence linking decreased knee flexion and increased knee abduction angles as predictive of future injury2. While the aforementioned study did not produce a change to the knee abduction angle (likely due to a ceiling effect), there was a significant change in knee flexion angle, which may aide in decreasing the likelihood of future injury. While this is promising preliminary evidence, in order to have a significant impact, an injury prevention program must be repetitive and participants must have good compliance7,8 to create a long-term change in movement pattern. This study, due to its design, does not capture this aspect.

References

1. Ericksen HM, Thomas AC, Gribble PA, Doebel SC, Pietrosimone BG. Immediate Effects of Real-Time Feedback on Jump-Landing Kinematics. Journal of Orthopaedic & Sports Physical Therapy. 2015; 45(2): 112–118. doi:10.2519/jospt.2015.4997.

2. Hewett TE, et al. Biomechanical Measures of Neuromuscular Control and Valgus Loading of the Knee Predict Anterior Cruciate Ligament Injury Risk in Female Athletes: A Prospective Study. American Journal of Sports Medicine. 2005;33(4):492–501. doi:10.1177/0363546504269591.

3. Kamath GV. Anterior Cruciate Ligament Injury, Return to Play, and Reinjury in the Elite Collegiate Athlete: Analysis of an NCAA Division I Cohort. Am J Sports Med. 2014;42(7):1638–1643. doi:10.1177/0363546514530866.

4. Leathers MP, Merz A, Wong J, Scott T, Wang JC, Hame SL. Trends and Demographics in Anterior Cruciate Ligament Reconstruction in the United States. Journal of Knee Surgery. 2015. [Epub ahead of print]

5. Paterno MV, Rauh MJ, Schmitt LC, Ford KR, Hewett TE. Incidence of Second ACL Injuries 2 Years After Primary ACL Reconstruction and Return to Sport. Am J Sports Med. 2014;42(7):1567–1573. doi:10.1177/0363546514530088.

6. Rugg CM, Wang D, Sulzicki P, Hame SL. Effects of prior knee surgery on subsequent injury, imaging, and surgery in NCAA collegiate athletes. Am J Sports Med. 2014;42(4):959–964. doi:10.1177/0363546513519951.

7. Sugimoto D, Myer GD, Bush HM, Hewett TE. Effects of Compliance on Trunk and Hip Integrative Neuromuscular Training on Hip Abductor Strength in Female Athletes. Journal of Strength and Conditioning Research. 2014;28(5):1187–1194. doi:10.1097/JSC.0000000000000228.

8. Sugimoto D, Myer GD, Bush HM, Klugman MF, McKeon JMM, Hewett TE. Compliance With Neuromuscular Training and Anterior Cruciate Ligament Injury Risk Reduction in Female Athletes: A Meta-Analysis. Journal of Athletic Training. 2012;47(6):714–723. doi:10.4085/1062-6050-47.6.10.

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

Untitled

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. 

Research Review: Manual Physical Therapy and Perturbation Exercises in Knee Osteoarthritis

Rhon et al, 2013

Study Design

Prospective, observational cohort study.

Subjects

Fifteen participants (7 male, 8 female) with a mean age of 55 years old were recruited from a convenience sample of consecutive patients evaluated for knee osteoarthritis (OA) at the Physical Therapy Clinic, Brooke Army Medical Center, San Antonio, Texas. With regards to severity, ten patients had bilateral symptoms, all 15 patients had radiographic signs of knee OA, and 10 had visible boney enlargement of the knee joint. Additionally, four of the included patients were active duty military personnel.

Inclusion Criteria: Utilizing criteria proposed by Altman (1991) and Altman et al (1986), the participants were included if they met at least one of the following three clinical clusters.

1. Knee pain for most days of the prior month: AND Crepitus with active motion and Morning stiffness in knee 38 years
2. Knee pain for most days of the prior month: AND Crepitus with active motion and Morning stiffness in knee > 30 minutes and Bony enlargement
3. Knee pain for most days of the prior month: AND No crepitus and Bony enlargement

Additional inclusion criteria include being eligible for care in a military medical treatment facility, minimum age 38 years old, and the ability to read, write, and speak sufficient English to complete the outcome tools.

Exclusion Criteria: Only periarticular pain or pain referred from another region (no joint pain), injections to the knee within the last 30 days, history of knee joint replacement surgery on involved limb, evidence of other systemic rheumatic condition (lupus, rheumatoid arthritis, psoriasis, or gout), and balance deficits from other non-musculoskeletal conditions (neurologic impairments, diabetic neuropathy, cerebellar disorders, or Parkinson disease)

Methods

Outcome Measures: The Western Ontario and McMaster Universities arthritis index (WOMAC), Global Rating of Change (GROC), Functional Squat Test (FST) evaluated with numerical pain rating scale (NPRS) and range of motion (ROM), and the Step-Up Test (SUT). Additionally, tolerance to treatment was determined by asking the participants a series of questions regarding whether their symptoms had gotten significantly worse at five different time points since their last visit. Time points included were immediately following treatment, several hours following treatment, that evening prior to bed, the following morning, and from the following morning until the follow-up (approximately 72 hours later).

Evaluation: The initial evaluation included a detailed history, review of systems, and physical examination. The history included questions regarding the duration, severity, location, and distribution of symptoms. The physical examination included functional tests, palpation of bony landmarks, ROM measurement, muscle length tests, and manual assessment of the joints and soft tissues of the lower extremity.

Interventions: Each patient was treated two times per week for four weeks and received both manual therapy and perturbation interventions. Visits included joint and soft-tissue mobilization, which was supplemented with stretching, ROM, and strengthening exercises. Additionally, each patient was provided with a home exercise program targeting their specific functional limitations. The manual therapy techniques were tailored to the impairments of each individual patient, however these interventions included varying grades of knee flexion, knee extension, and patella mobilizations. With regards to perturbation training, each patient was progressed based upon clinical reasoning and as tolerated by the individual patient. Each program generally started with more emphasis on manual therapy interventions and towards the end of the program, the focus switched to perturbation exercises.

Results

WOMAC: The mean WOMAC score demonstrated a statistically significant improvement from baseline to 6 months with a 46% improvement, which was well above the minimal clinically important difference (MCID) of 12%. Additionally, the total WOMAC score was significantly improved at the end of the 4 week intervention period and remained improved at the 6 month follow-up. Finally, the only WOMAC sub-scale that did not remain improved at the 6 month follow-up was the ‘Stiffness’ sub-scale.

GROC: At the one month follow-up, 87% of patients reached the 3 point change in GROC to identify a clinically important change. Changes decreased over time with 80% of patients still maintaining this threshold of change at 3 months and only 60% at the final 6 month follow-up. Additionally, and probably more importantly, 47% of patients met the threshold for ‘dramatic change’ (GROC > 6) at all time points.

FST: Following the 4 week intervention period, statistically significant improvements in NPRS and ROM during the FST were documented. An average decrease from 5 to 3 on the NPRS and an improvement from 29° to 35° with regards to ROM.

SUT: The Step-Up Test values also significantly improved at the 4 week evaluation with a mean improvement of 4-5 steps during the 15 second test. This translated to an average increase from 9 to 14 steps completed during the test.

Limitations

Due to the prospective cohort design of this study, no comparison group was included, thus no cause and effect relationship can be identified. Additionally, some of the improvements seen in this study could be attributed to other medical treatment many of the patients received. By 6 months five patients had received knee joint injections of either corticosteroid or viscosupplementation and two of those same patients received arthroscopic surgery. Of these patients receiving either injection or arthroscopic surgery, none reported improvement in symptoms immediately following the aforementioned procedures. Pain medication was used by 12 patients initially (10 patients daily; 2 patients as needed), including non-steroidal anti-inflammatory drugs and/or acetaminophen. However, it should be pointed out that at each of the follow-up points, fewer patients were taking medications than at baseline.

Clinical Implications

While no cause and effect relationship can be determined, this study does demonstrate theoretical effectiveness of a combined manual therapy and perturbation training approach to the treatment of knee osteoarthritis. This approach was associated with significant improvements in pain, function, and balance measures. There were several limitations evident within the study, however the potential positive impact of the interventions provided add to the current literature supporting perturbation and manual therapy techniques for patients suffering from knee osteoarthritis.

Rhon D, et al. Manual physical therapy and perturbation exercises in knee osteoarthritis. Journal of Manual & Manipulative Therapy. 2013; 21(4): 220–228.

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

Untitled

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.

Research Review: Effect of Prehabilitation on the Outcome of Anterior Cruciate Ligament Reconstruction

Prehab

In my first in a series of ‘Research Review’ articles for MedBridge Education, I will review a recent study that appeared in The American Journal of Sports Medicine. Shaarani et al investigated the utility of a Prehabilitation program for patients scheduled to undergo anterior cruciate ligament reconstruction (ACLR). Considering the variable rate of return to sport following ACLR (43-93%), urgency exists for improving rehabilitation following ACL injury.

Study Design

Randomized Controlled Trial (RCT).

Subjects

20 patients with a rupture of the ACL were recruited from 2 orthopedic centers between December 2010 and December 2011. Following randomization, 11 patients were assigned to the intervention group while 9 were placed in the control group. No significant differences existed between groups for age, height, weight, body mass index, and Tegner activity level before/after injury.

Inclusion Criteria: Males between the ages of 18 and 45 years old with an isolated ACL tear. All patients had a positive anterior drawer, Lachman, and pivot-shift test.

Exclusion Criteria: Associated fractures, meniscal repair, collateral ligament injury requiring repair/reconstruction, comorbidities that would be contraindicated from high physical exertion, and living outside the Greater Dublin area for practical reasons related to exercise supervision and exercise gym usage.

Methods

Outcome Measures: Single-leg hop test, peak torque of the quadriceps and hamstring, muscle cross-sectional area (CSA), Modified Cincinnati Knee Rating System (mCKRS), and Tegner activity level.

Randomization: From a pool of 437 patients, 56 were eligible following inclusion/exclusion criteria. There were, however, 14 non-responders and 19 subjects who refused to participate. Randomization was determined following outpatient consultation. Opaque envelopes were used to randomly assign individuals to their group.

Interventions: The Prehabilitation Group (PG) was enrolled in a 6-week exercise program, which consisted of supervised resistance and balance training. This program was comprised of 4 exercise sessions per week, which included 2 supervised gym sessions and 2 supervised home sessions. The primary focus was lower limb strengthening with a quadriceps emphasis, as well as proprioceptive training. Each exercise consisted of 3 sets of 12 repetitions and the weights were increased weekly by 10-15%. During the last gym session, the weights were reduced to the previous week’s value to prevent preoperative fatigue and to favor the muscular response to endurance and gaining mass. In contrast, the Control Group (CG) was not given a pre-operative exercise program; however these patients were not discouraged from exercise or taking part in normal activity of daily living before surgery. Postoperatively, both groups received standardized physical therapy sessions, which included increasing range of motion (ROM) and weight-bearing while improving symmetry and gait pattern.

Results

Immediately following the 6-week Prehabilitation program, the intervention group showed several significant improvements prior to surgery. These benefits included the following: significantly improved single-leg hop testing; increased quadriceps and vastus medialis CSA, and improved mCKRS. At 12 weeks post-operative, the rate of decline in the single leg hop test was less and the mCKRS was significantly improved in the exercise group compared with the CG, however no changes existed between groups in CSA. Of particular importance was that on average patients in the PG returned to sport in 34.2 weeks versus 42.5 weeks in the CG though this did not reach statistical significance (P=0.055).

Limitations

The most important limitations of this study were the small sample size (n = 20) and lack of a long-term follow-up in comparison to the typical rehabilitation length. It is therefore difficult to extrapolate these short-term benefits to long-term outcomes. Additionally, single-leg hop and peak quadriceps torque testing were observed by an individual who was not blinded to the treatment groups. Finally, in terms of the study design itself, utilizing a sham exercise program would have eliminated the potential attention bias.

Clinical Implications

This pilot study supports implementing a prehabilitation program following ACL injury in preparation for surgical intervention. As previously stated, the percentage of patients who are able to return to sport following ACLR is broad and relatively unimpressive. The benefits of prehabilitation demonstrated during this initial investigation could have a profound impact on return to sport following ACLR. The improvement in single-leg hop testing is particularly encouraging, as it has been documented to be a problematic area with regards to athletes following ACLR. Both Myers et al and Xergia et al found significant asymmetries in single-leg hop testing between individuals who had undergone ACLR and uninjured control subjects. Following rehabilitation, athletes need to have the proprioceptive ability and confidence to perform single-leg stopping, cutting, and jumping activities without hesitation. Coinciding with these measures, this study did show a shorter timeframe for return to sport in athletes who completed a course of prehabilitation. Despite not reaching statistical significance, an average decrease of over 8 weeks is clinically meaningful to any sports medicine practitioner, athlete, or coach.

Shaarani SR, O’Hare C, Quinn A, Moyna N, Moran R, O’Byrne JM. Effect of Prehabilitation on the Outcome of Anterior Cruciate Ligament Reconstruction. American Journal of Sports Medicine. 2013; 41(9): 2117–2127.