Cervicothoracic Manual Therapy Plus Exercise Therapy Versus Exercise Therapy Alone in the Management of Individuals With Shoulder Pain: A Multicenter Randomized Controlled Trial

Author Names

Mintken, P., McDevitt, A., Cleland, J., Boyles, R., Beardslee, A., Burns, S., Haberl, M., Hinrichs, L., Michener, L.

Reviewer Name

Wes Pritzlaff, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

 

Paper Abstract

Study Design Multicenter randomized controlled trial. Background Cervicothoracic manual therapy has been shown to improve pain and disability in individuals with shoulder pain, but the incremental effects of manual therapy in addition to exercise therapy have not been investigated in a randomized controlled trial. Objectives To compare the effects of cervicothoracic manual therapy and exercise therapy to those of exercise therapy alone in individuals with shoulder pain. Methods Individuals (n = 140) with shoulder pain were randomly assigned to receive 2 sessions of cervicothoracic range-of-motion exercises plus 6 sessions of exercise therapy, or 2 sessions of high-dose cervicothoracic manual therapy and range-of-motion exercises plus 6 sessions of exercise therapy (manual therapy plus exercise). Pain and disability were assessed at baseline, 1 week, 4 weeks, and 6 months. The primary aim (treatment group by time) was examined using linear mixed-model analyses and the repeated measure of time for the Shoulder Pain and Disability Index (SPADI), the numeric pain-rating scale, and the shortened version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH). Patient-perceived success was assessed and analyzed using the global rating of change (GROC) and the Patient Acceptable Symptom State (PASS), using chi-square tests of independence. Results There were no significant 2-way interactions of group by time or main effects by group for pain or disability. Both groups improved significantly on the SPADI, numeric pain-rating scale, and QuickDASH. Secondary outcomes of success on the GROC and PASS significantly favored the manual therapy-plus-exercise group at 4 weeks (P = .03 and P<.01, respectively) and on the GROC at 6 months (P = .04). Conclusion Adding 2 sessions of high-dose cervicothoracic manual therapy to an exercise program did not improve pain or disability in patients with shoulder pain, but did improve patient-perceived success at 4 weeks and 6 months and acceptability of symptoms at 4 weeks. More research is needed on the use of cervicothoracic manual therapy for treating shoulder pain. Level of Evidence Therapy, level 1b. Prospectively registered March 30, 2012 at www.ClinicalTrials.gov (NCT01571674). J Orthop Sports Phys Ther 2016;46(8):617-628. doi:10.2519/jospt.2016.6319.

 

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

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

• Yes

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

• Yes

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

• Yes

4. Were study participants and providers blinded to treatment group assignment?

• No

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

• Yes

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

• Yes

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

• Yes

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

• Yes

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

• Yes

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

• Yes

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

• Yes

12. 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?

• Yes

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

• Yes

14. 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

There were no significant two-way interactions of group by time or main effects by groups for pain (measured via NPRS) or disability (measured via SPADI and QuickDASH) at baseline, one week, four weeks, or six months post-treatment in individuals with shoulder pain either receiving exercise therapy alone (two sessions of cervicothoracic ROM exercises followed by six sessions of exercise therapy) or exercise therapy and high-dose cervicothoracic manual therapy (concurrent with cervicothoracic ROM exercises during first two sessions).

Key Finding #2

Patients with shoulder pain who received two sessions of cervicothoracic manual therapy in addition to cervicothoracic ROM and exercise therapy reported significantly higher patient-perceived success and acceptability of symptoms on the GROC and PASS at four weeks and six months and four weeks following treatment, respectively, compared to patients who did not receive cervicothoracic manual therapy.

Key Finding #3

Patients in both cervicothoracic manual therapy with exercise therapy and exercise therapy-only groups demonstrated improvement on the NPRS, SPADI, QuickDASH, GROC, and PASS from baseline to subsequent follow-ups.

 

Please provide your summary of the paper

This randomized control trial sought to compare the changes in pain (NPRS), disability (SPADI and QuickDASH), patient-perceived success (GROC), and acceptability of symptoms (PASS) across six months following treatment between individuals with shoulder pain receiving cervicothoracic manual therapy plus exercise therapy or exercise therapy alone. The data were analyzed utilizing validated measures outlined in the methods section. All patients started by receiving two sessions of cervicothoracic ROM exercises followed by six sessions of exercise therapy targeted at neuromuscular re-education, flexibility, and postural strengthening exercises for two sessions per week across four weeks (eight sessions total). The cervicothoracic manual therapy group also received five different HVLAT manipulations (up to 10) directed at the upper, middle, and lower thoracic spine and one lower cervical mobilization technique at the start of the first two sessions. While all patients met minimal clinically important differences on all outcome measures, there were no significant differences in pain or disability between groups; however, the group receiving cervicothoracic manual therapy demonstrated significantly greater patient-perceived success and acceptability of symptoms ratings at the four-week treatment session. These results suggest that cervicothoracic manipulations and mobilizations do not improve patient-reported outcomes compared to exercise alone in individuals with shoulder pain; however, it suggests that cervicothoracic manual therapy may promote patient-perceived success of treatment. The article thoroughly summarizes all cervicothoracic manual therapy, cervicothoracic ROM, and exercise therapy interventions in the appendices.

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

The results of this study may not change how neutral clinicians practice and may support the confirmation biases of clinicians who feel positively and negatively about manual therapy. For clinicians who view manual therapy neutrally or negatively, the results suggest that manual therapy does not add value to exercise therapy in improving a patient’s pain or disability outcomes. However, for clinicians who view manual therapy positively, the results suggest that manual therapy helps to improve patient perceptions of progress and success with equivalent pain and disability outcomes, so it should be included to improve patient satisfaction. These results have high external validity with transferability to the clinic as the inclusion criteria were broad and patients were recruited across the United States. The inclusion criteria include participants between ages 18 to 65, a primary complaint of shoulder pain (pain between neck and elbow), and greater than 20% disability as measured by the SPADI. While this study looked at patient-reported outcome measures, future studies may further analyze the effect of cervicothoracic manual therapy in addition to exercise in physical performance outcome measures, including but not limited to ROM and muscular endurance, strength, and power.