Thoracic Manual Therapy Improves Pain and Disability in Individuals With Shoulder Impingement Syndrome Compared With Placebo: A Randomized Controlled Trial With 1-Year Follow-up – Duke Center of Excellence in Manual and Manipulative Therapy

Author Names

Hunter, D; Rivett, D; McKiernan, S; Luton, R; Snodgrass, S.

Reviewer Name

Katherine Terkoski SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Objective To investigate whether muscle energy technique (MET) to the thoracic spine decreases the pain and disability associated with shoulder impingement syndrome (SIS). Design Single-center, 3-arm, randomized controlled trial, single-blind, placebo control with concealed allocation and a 12-month follow-up.Setting Private osteopathic practice. Participants Three groups of 25 participants (N=75) 40 years or older with SIS received allocated intervention once a week for 15 minutes, 4 consecutive weeks. Interventions Participants were randomly allocated to MET to the thoracic spine (MET-only), MET plus soft tissue massage (MET+STM), or placebo. Main Outcome Measures Primary outcome measure: Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Secondary outcome measures: Shoulder Pain and Disability Index (SPADI) questionnaire; visual analog scale (VAS) (mm/100): current, 7-day average, and 4-week average; Patient-Specific Functional Scale (PSFS); and Global Rating of Change (GROC). Measures recorded at baseline, discharge, 4-week follow-up, 6 months, and 12 months. Also baseline and discharge thoracic posture and range of motion (ROM) measured using an inclinometer. Statistical analysis included mixed-effects linear regression model for DASH, SPADI, VAS, PSFS, GROC, and thoracic posture and ROM. Results MET-only group demonstrated significantly greater improvement in pain and disability (DASH, SPADI, VAS 7-day average) than placebo at discharge (mean difference, DASH=−8.4; 95% CI, −14.0 to −2.8; SPADI=−14.7; 95% CI, −23.0 to −6.3; VAS=−15.5; 95% CI, −24.5 to −6.5), 6 months (−11.1; 95% CI, −18.6 to −3.7; −14.9; 95% CI, −26.3 to −3.5; −14.1; 95% CI, −26.0 to −2.2), and 12 months (−13.4; 95% CI, −23.9 to−2.9; −19.0; 95% CI, −32.4 to −5.7; −17.3; 95% CI, −30.9 to −3.8). MET+STM group also demonstrated greater improvement in disability but not pain compared with placebo at discharge (DASH=−8.2; 95% CI, −14.0 to −2.3; SPADI=−13.5; 95% CI, −22.3 to −4.8) and 6 months (−9.0; 95% CI, −16.9 to −1.2; −12.4; 95% CI, −24.3 to −0.5). For the PSFS, MET-only group improved compared with placebo at discharge (1.3; 95% CI, 0.1-2.5) and 12 months (1.8; 95% CI, 0.5-3.2); MET+STM at 12 months (1.7; 95% CI, 0.3-3.0). GROC: MET-only group improved compared with placebo at discharge (1.5; 95% CI, 0.9-2.2) and 4 weeks (1.0; 95% CI, 0.1-1.9); MET+STM at discharge (1.2; 95% CI, 0.5-1.9) and 6 months (1.2; 95% CI, 0.1-1.3). There were no differences between MET-only group and MET+STM, and no between-group differences in thoracic posture or ROM. Conclusions MET of the thoracic spine with or without STM improved the pain and disability in individuals 40 years or older with SIS and may be recommended as a treatment approach for SIS.

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)?

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?

Cannot Determine, Not Reported, or Not Applicable

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

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?

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?

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

Cannot Determine, Not Reported, or Not Applicable

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

MET-only group demonstrated significantly greater improvement in pain and disability than placebo group.

Key Finding #2

MET+STM group demonstrated greater improvement in disability but not pain compared with placebo group.

Key Finding #3

There were no differences between MET-only group and MET+STM group.

Key Finding #4

There were no differences in thoracic posture or ROM.

Please provide your summary of the paper

The study aimed to investigate whether muscle energy technique (MET) to the thoracic spine decreases pain and disability associated with shoulder impingement syndrome. Three groups of 25 participants 40 years or older with shoulder impingement syndrome received their allocated intervention once a week for 15 minutes for 4 consecutive weeks. The intervention groups included MET to thoracic spine (MET-only), MET plus soft tissue massage (MET+STM), or placebo. The primary outcome measure was the Disabilities of the Arm, Shoulder, and Hand. Secondary outcome measures included the Shoulder Pain and Disability Index, Visual Analog Scale, Patient-Specific Functional Scale, and Global Rate of Change. Measures were recorded at baseline, discharge, 4 week follow up, 6 months, and 12 months. At baseline and discharge, thoracic posture and ROM were measured using an inclinometer. Results showed the MET-only group demonstrated significantly greater improvement in pain and disability than the placebo group. The MET+STM group demonstrated greater improvement in disability but not pain compared with placebo group. There were no differences between MET-only group and MET+STM group and there was no difference in thoracic posture or ROM.

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

This study provides good direction for clinical management of patients with shoulder impingement syndrome. One aspect of the study that I thought was beneficial was the followup with their patients. It was interesting to see how their patients were doing up to 1 year post since their intervention took place only over 4 weeks. While I enjoyed reading this study, there were a few things I thought they could improve on. The researchers noted that the interventions did not have an effect on thoracic posture or mobility, however, I am curious if they saw any improvement in shoulder ROM since they only commented on shoulder pain and disability. Overall, I thought this was a high quality study providing good insight into how the thoracic spine can impact shoulder impingement syndrome.