Corticosteroid injections (CSI) are a recommended and often-used first-line intervention for shoulder impingement syndrome (SIS) in primary care and orthopaedic settings. Manual physical therapy (MPT) offers a non-invasive approach with negligible risk for managing SIS. There is limited evidence to suggest significant long-term improvements in pain, strength and disability with the use of MPT, and there are conflicting reports from systematic reviews that question the long-term efficacy of CSI. Specifically, the primary objective is to compare the effect of CSI and MPT on pain and disability in subjects with SIS at 12 months.
This pragmatic randomised clinical trial will be a mixed-model 2×5 factorial design. The independent variables are treatment (MPT and CSI) and time with five levels from baseline to 1 year. The primary dependent variable is the Shoulder Pain and Disability Index, and the secondary outcome measures are the Global Rating of Change and the Numeric Pain Rating Scale. For each ANOVA, the hypothesis of interest will be the two-way group-by-time interaction.
Methods and analysis
The authors plan to recruit 104 participants meeting established impingement criteria. Following examination and enrolment, eligible participants will be randomly allocated to receive a pragmatic approach of either CSI or MPT. The MPT intervention will consist of six sessions, and the CSI intervention will consist of one to three sessions. All subjects will continue to receive usual care. Subjects will be followed for 12 months.
Dissemination and ethics
The protocol was approved by the Madigan Army Medical Center Institutional Review Board. The results may have an impact on clinical practice guidelines. This study was funded in part by the Orthopaedic Physical Therapy Products Grant through the American Academy of Orthopaedic Manual Physical Therapists.
Shoulder pain is a common symptom in patients seeking healthcare for musculoskeletal complaints.
Corticosteroid injections (CSI) are a common first-line intervention for shoulder pain in primary care settings, but their long-term efficacy has not been established.
The long-term efficacy of manual physical therapy and CSI will be evaluated and compared from baseline out to 1 year after enrollment.
Manual physical therapy has been shown to provide improvements in pain and function in patients with shoulder impingement but has not been directly compared with CSI.
Understanding which interventions have better long-term outcomes may be instrumental in helping improve clinical practice guidelines for the management of shoulder impingement syndrome.
Strengths and limitations of this study
This randomised controlled study will compare the effectiveness of a manual physical therapy approach to a corticosteroid injection in patients with shoulder impingement.
This is a pragmatic study evaluating two interventions that are standard practice and have been shown to be effective for shoulder impingement.
Even as a single blinded randomised clinical trial there is no true control group, and we cannot state whether true a cause-and-effect relationship exists.
Owing to the pragmatic nature of the study, the intervention will not be standardised, which could make it difficult for clinicians to replicate.
The lack of a gold standard with the diagnosis of shoulder impingement makes this population difficult to study.