Author Names
Langevin, P., PT, FCAMPT, MClSc; Desmeules, F., PT, PhD; Lamothe, M., PT, MS; Robitaille, S., PT; Roy, J., PT, PhD
Reviewer Name
Jordan Jaklic, SPT
Reviewer Affiliation(s)
Duke University School of Medicine, Doctor of Physical Therapy Division
Paper Abstract
Abstract
Study Design
Participant- and assessor-blinded randomized clinical trial.
Objectives
To compare a rehabilitation program thought to increase the size of the intervertebral foramen (IVF) of the affected nerve root to a rehabilitation program that doesn’t include any specific techniques thought to increase the size of the IVF in patients presenting with cervical radiculopathy (CR).
Background
Clinical approaches for the treatment of CR commonly include exercises and manual therapy techniques thought to increase the size of the IVF, but evidence regarding the effectiveness of these specific manual therapy techniques is scarce.
Methods
Thirty-six participants with CR were randomly assigned either to a group that received a manual therapy and exercise program aimed at increasing the size of the IVF of the affected nerve root (experimental group, n = 18) or to a group that received a manual therapy and exercise program without the specific goal of increasing the size of the IVF of the affected level and side (comparison group, n = 18). Primary (Neck Disability Index) and secondary (shortened version of the Disabilities of the Arm, Shoulder and Hand questionnaire [QuickDASH] and numeric pain-rating scale) outcomes were evaluated at baseline, at the end of the 4-week program (week 4), and 4 weeks later (week 8). A mixed-model, 2-way analysis of variance was used to analyze treatment effects.
Results
No significant group-by-time interaction or group effect was observed for Neck Disability Index, QuickDASH, and numeric pain-rating scale scores (P≥.14) following the intervention. However, both groups showed statistically and clinically significant improvement from baseline to week 4 and to week 8 in Neck Disability Index, QuickDASH, and numeric pain-rating scale scores (P<.05).
Conclusion
Results suggest that manual therapy and exercises are effective in reducing pain and functional limitations related to CR. The addition of techniques thought to increase the size of the IVF of the affected nerve root yielded no significant additional benefits. Given the absence of a “no treatment” group, a spontaneous resolution of symptoms cannot be excluded. However, the magnitude of improvement makes spontaneous resolution unlikely. The trial was registered at ClinicalTrials.gov (NCT01500044).
Level of Evidence
Therapy, level 1b-. J Orthop Sports Phys Ther 2015;45(1):4–17. Epub 24 Nov 2014. doi:10.2519/jospt.2015.5211
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
- Yes
- Was the method of randomization adequate (i.e., use of randomly generated assignment)?
- Yes
- Was the treatment allocation concealed (so that assignments could not be predicted)?
- Yes
- Were study participants and providers blinded to treatment group assignment?
- Were the people assessing the outcomes blinded to the participants’ group assignments?
- Yes
- 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?
- Yes
- Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
- Yes
- 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)?
- Cannot Determine, Not Reported, or Not Applicable
- Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
- Yes
- 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?
- No
- Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
- Yes
- Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
- Yes
Key Finding #1
Although there was no statistical difference between the group that received intervention to increase the size of the IVF on the same side and the group that did not increase the size of the IVF, both groups achieved highly favorable outcomes in terms of pain, disability, and patient-perceived improvement.
Key Finding #2
The findings of this study suggest that there are no limitations to using mobilizations and exercises that are specific to the level of the radiculopathy in acute or subacute patients with cervical radiculopathy.
Please provide your summary of the paper
In this randomized control trial, 36 patients with cervical radiculopathy symptoms were randomly assigned to manual therapy groups that either increased the intervertebral foramen (IVF) at the same level and side or did not increase the IVF at the same level and side. Patients all received 4 weeks of treatment and measured symptoms at baseline, after 4 weeks of treatment, and 4 weeks post the end of treatment. The patients completed the Neck Disability Index, QuickDASH, and numeric pain rating scale at each bench mark. Patients were included in the study if they satisfied the following 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 following clinical tests (positive likelihood ratio for CR of 6): Spurling A test, upper-limb tension test A, cervical distraction test, and less than 60° of cervical rotation to the painful side. Patients were excluded from the study if they had (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. At the end of the study, the results concluded that both groups experienced significant improvement in patient-reported outcomes. However, there was no statistical difference between the group that received manual therapy to increase the IVF on the same level and side and the group that did not receive manual therapy to increase the IVF on the same level and side. Although there were no differences between groups, it is hypothesized that some form of manual therapy is better than none.
Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
Although this paper had a small sample size, the conclusion can be applied to all settings. Even though increasing the IVF on the same side and level did not show any more improvement than other manual therapy techniques, this paper did show that some amount of manual therapy is helpful for patient outcomes. Patients may not be able to lie in standardized positions to receive manual therapy in the cervical spine, but this paper demonstrates that it may still be beneficial to provide manual therapy in any capacity the patient can tolerate. Therapists can even focus on muscle stiffness if joint mobilizations are not feasible for the patient in order to offer some relief. The conclusions of this paper can be applied in most settings including outpatient and acute care.
