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Abstract
Introduction 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.
Design 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.
Trial Registration http://clinicaltrials.gov/ NCT01190891.
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Footnotes
Correction notice The “To cite: …” information and running footer in this article have been updated with the correct volume number (volume 1).
To cite: Rhon DI, Boyles RE, Cleland JA, et al. A manual physical therapy approach versus subacromial corticosteroid injection for treatment of shoulder impingement syndrome: a protocol for a randomised clinical trial. BMJ Open 2011;1:e000137. doi:10.1136/bmjopen-2011-000137
Funding This study is funded in part by the Orthopaedic Physical Therapy Products Grant through the American Academy of Orthopaedic Manual Physical Therapists.
Competing interests None.
Ethics approval Ethics approval was provided by the Madigan Army Medical Center Institutional Review Board.
Contributions DIR conceived the idea for the project and is the PI. All authors contributed to writing and reviewing the protocol, as well as reviewing and submitting the protocol for publication. JAC provided advice with statistical and methods design. DIR and REB will provide all the direct interventions for the MPT group. DLB will perform all the injections for the CSI group.
Provenance and peer review Not commissioned; externally peer reviewed.