Author Names
Engel, R., Gonski, P., Beath, K., Vemulpad, S.
Reviewer Name
Alexandra Hultstrom, SPT
Reviewer Affiliations
Duke University School of Medicine, Doctor of Physical Therapy Division
Paper Abstract
Study design Randomized clinical trial. Objective To investigate the effect of including manual therapy (MT) in a pulmonary rehabilitation program for patients with chronic obstructive pulmonary disease (COPD). Background The primary source of exercise limitation in people with COPD is dyspnea. The dyspnea is partly caused by changes in chest wall mechanics, with an increase in chest wall rigidity (CWR) contributing to a decrease in lung function. As MT is known to increase joint mobility, administering MT to people with COPD carries with it the potential to influence CWR and lung function. Methods Thirty-three participants with COPD, aged between 55 and 70 years (mean = 65·5±4 years), were randomly assigned to three groups: pulmonary rehabilitation (PR) only, soft tissue therapy (ST) and PR, and ST, spinal manipulative therapy (SM), and PR. Outcome measures including forced expiratory volume in the 1st second (FEV1), forced vital capacity (FVC), 6-minute walking test (6MWT), St. George’s respiratory questionnaire (SGRQ), and the hospital anxiety and depression (HAD) scale were recorded at 0, 8, 16, and 24 weeks. Results There was a significant difference in FVC between the three groups at 24 weeks (P = 0·04). For the ST+SM+PR group versus PR only the increase was 0·40 l (CI: 0·02, 0·79; P = 0·03). No major or moderate adverse events (AE) were reported following the administration of 131 ST and 272 SM interventions. Discussion The increase in FVC is a unique finding. Although the underlying mechanisms responsible for this outcome are not yet understood, the most likely explanation is the synergistic effect resulting from the combination of interventions. These results support the call for a larger clinical trial in the use of MT for COPD.
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?
- No
- 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)?
- No
- Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
- Cannot Determine, Not Reported, or Not Applicable
- 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?
- Yes
- Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
- No
- 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)?
- No
- 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 was a significant difference between groups for Forced Vital Capacity (FVC) at 24 weeks, which is eight weeks after the end of intervention.
Key Finding #2
There was a significant difference in distance walked in the 6MWT from week 16 to week 24 between the Soft Tissue + Spinal Manipulation + Pulmonary Rehab group and the Soft Tissue + Pulmonary Rehab group.
Key Finding #3
Though increases in lung function (as measured by FVC) were found, there were no improvements in quality of life measures (HAD and SGRQ) in any of the groups.
Please provide your summary of the paper
There appears to be a lasting effect (8 weeks) of Soft Tissue Mobilization (ST) + Spinal Manipulation (SM) + Pulmonary Rehab on lung capacity as measured by FVC. However, it is unclear as to whether these changes are the result of ST or SM. Additionally, there were changes in the 6MWT in the group where SM was added. There were no improvements in quality of life measures (HAD & SGRQ) though lung capacity (FVC) and endurance (6MWT) increased. No major or moderate adverse events were reported. The underlying mechanism that led to these changes is still unknown though the authors speculate that it may be due to synergistic effects of soft tissue mobilization of respiratory muscles combined with spinal manipulation of related thoracic intervertebral and costovertebral joints.
Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
Overall, this study calls for further investigation and research with larger sample sizes before any generalizations and firm conclusions can be drawn. There were many limitations, such as small sample size and unknown outside effects. The participants were encouraged to exercise on their own after the Pulmonary Rehab (PR) sessions had ended (weeks 16-24) and their activity levels outside of PR were not tracked. Additionally, there were no reports of medications used or whether the patients were dependent on O2. Finally, the implications from this study and future research into the intersection of Manual Therapy and Pulmonary Rehab indicates that future COPD rehabilitation may need to be interdisciplinary between orthopedic and cardiopulmonary providers.
