The Effect of Spinal Mobilization With Leg Movement in Patients With Lumbar Radiculopathy – A Double- Blind Randomized Controlled Trial – Duke Center of Excellence in Manual and Manipulative Therapy

Author Names

Satpute, K., Hall, T., Bisen, R., Lokhande, P.

Reviewer Name

Bree Tucker, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Objectives: To evaluate the effect of spinal mobilization with leg movement (SMWLM) on low back and leg pain intensity, disability, pain centralization, and patient satisfaction in participants with lumbar radiculopathy.
Design: A double-blind randomized controlled trial.
Setting: General hospital.
Participants: Adults (NZ60; mean age 44y) with subacute lumbar radiculopathy.
Interventions: Participants were randomly allocated to receive SMWLM, exercise and electrotherapy (nZ30), or exercise and electrotherapy alone (nZ30). All participants received 6 sessions over 2 weeks.
Main Outcome Measures: The primary outcomes were leg pain intensity and Oswestry Disability Index score. Secondary variables were low back pain intensity, global rating of change (GROC), straight leg raise (SLR), and lumbar range of motion (ROM). Variables were evaluated blind at baseline, post-intervention, and at 3 and 6 months of follow-up.
Results: Significant and clinically meaningful improvement occurred in all outcome variables. At 2 weeks the SMWLM group had significantly greater improvement than the control group in leg pain (MD 2.0; 95% confidence interval [95% CI], 1.4-2.6) and disability (MD 3.9; 95% CI, 5.5- 2.2). Similarly, at 6 months, the SMWLM group had significantly greater improvement than the control group in leg pain (MD 2.6; 95% CI, 1.9- 3.2) and disability (MD 4.7; 95% CI, 6.3-3.1). The SMWLM group also reported greater improvement in the GROC and in SLR ROM.

Conclusion: In patients with lumbar radiculopathy, the addition of SMWLM provided significantly improved benefits in leg and back pain, disability, SLR ROM, and patient satisfaction in the short and long term.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT

Was the method of randomization adequate (i.e., use of randomly generated assignment)?

Was the treatment allocation concealed (so that assignments could not be predicted)?

Were study participants and providers blinded to treatment group assignment?

Were the people assessing the outcomes blinded to the participants’ group assignments?

Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

Cannot Determine, Not Reported, or Not Applicable

Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?

Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?

Was there high adherence to the intervention protocols for each treatment group?

Cannot Determine, Not Reported, or Not Applicable

Were other interventions avoided or similar in the groups (e.g., similar background treatments)?

Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?

Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?

Cannot Determine, Not Reported, or Not Applicable

Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?

Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?

Key Finding #1

The inclusion of spinal mobilization with leg movement (SMWLM) in conjunction with exercise and TENS proved to significantly improve leg and low back pain, as well as disability and SLR ROM. Leg pain intensity and ODI scores reduced significantly more in those who received SMWLM post-intervention, at 3 months, and at 6 months than that of the control group.

Key Finding #2

Participants reported centralization of leg pain immediately after 2 weeks of intervention, more significantly in the SMWLM group in comparison to the control group. By the end of the trial, 100% of participants in the SMWLM group reported centralization.

Key Finding #3

Both groups showed improvements in all outcome measures performed; however, the SMWLM group demonstrated more significant improvements immediately after intervention that maintained throughout the duration of the trial.

Key Finding #4

Results of this study are consistent with those of others related to manual therapy treatment for lumbar radiculopathy; however, the addition of SMWLM resulted in more rapid and greater improvements in leg pain severity.

Please provide your summary of the paper

This study aimed to examine the benefits to spinal mobilization with leg movement (SMWLM) when added to traditional interventions in patients with lumbar radiculopathy. The trial followed a double-blind randomized control design which included patients presenting with unilateral radiating leg pain below the knee with associated low back pain. Sixty participants with severe disability ratings received 6 treatment sessions over 2 weeks and reported follow-ups at 3-months and 6-months. Participants either received SMWLM with exercise and TENS, or only exercise and TENS. Primary outcome measures of the visual analog scale (VAS) and Oswestry Disability Index (ODI), along with other supplemental outcome measures, were used to measure change in leg pain and disability.

Results of the study showed both groups demonstrated improvements on all outcome measures; however, the SMWLM group showed more significant improvements immediately after intervention that persisted 6 months later. Reports of leg pain reduced significantly more, as well as a reduction in ODI scores, in the SMWLM group at all three time-points of the trial in comparison to the control group. It was therefore concluded that the addition of SMWLM to exercise and TENS provided improvements in leg and low back pain, disability, and ROM in those with lumbar radiculopathy.

This was the first randomized control trial to evaluate the efficacy of SMWLM in the management of lumbar radiculopathy. Limitations to the study include not monitoring for compliance with the home exercise program and longer treatment sessions for the SMWLM group compared to the control. This study also only included participants who positively responded to a trial of SMWLM during examination.

Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.

Low back pain is a common musculoskeletal problem and can often be associated with radiculopathy. Manual therapy has been studied as an effective treatment for radicular symptoms. From this article, we learn that the inclusion of exercise and TENS alone for this patient population can help to further manage symptoms. However, the additional adaptation of SMWLM within therapy sessions may produce more rapid and long-lasting benefits for these patients suffering with severe leg pain secondary to suspected lumbar radiculopathy. Any manual therapy practitioner, or general physical therapist, can use this data to justify the implementation of similar treatment programs for this patient population. Pain-free mobilizations of nerves are preferable making the SMWLM a useful tool for management of radiculopathy to implement in regular PT practice. Future studies are recommended to identify the mechanism of action of SMWLM, as well as to investigate the efficacy of SMWLM compared to surgical treatment options.