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A randomized controlled trial of osteopathic manipulative treatment following knee or hip arthroplasty |
Licciardone JC, Stoll ST, Cardarelli KM, Gamber RG, Swift JN Jr, Winn WB |
The Journal of the American Osteopathic Association 2004 May;104(5):193-202 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
CONTEXT: Preliminary study results suggest that osteopathic manipulative treatment (OMT) may reduce pain, improve ambulation, and increase rehabilitation efficiency in patients undergoing knee or hip arthroplasty. OBJECTIVE: To determine the efficacy of OMT in patients who recently underwent surgery for knee or hip osteoarthritis or for a hip fracture. DESIGN: Randomized controlled trial involving hospital and postdischarge phases. SETTING: Hospital-based acute rehabilitation unit. PATIENTS: A total of 42 women and 18 men who were hospitalized between October 1998 and August 1999. INTERVENTION: Patients were randomly assigned to groups that received either OMT or sham treatment in addition to standard care. Manipulation was individualized and performed according to study guidelines regarding frequency, duration, and technique. MAIN OUTCOME MEASURES: Changes in Functional Independence Measure (FIM) scores and in daily analgesic use during the rehabilitation unit stay; length of stay; rehabilitation efficiency -- defined as the FIM total score change per rehabilitation unit day; and changes in Medical Outcomes Study Short Form-36 scores from rehabilitation unit admission to 4 weeks after discharge. RESULTS: Of 19 primary outcome measures, the only significant difference between groups was decreased rehabilitation efficiency with OMT (2.0 versus 2.6 FIM total score points per day; p = 0.01). Stratified analyses demonstrated that poorer OMT outcomes were confined to patients with osteoarthritis who underwent total knee arthroplasty (length of stay, 15.0 versus 8.3 days; p = 0.004; rehabilitation efficiency, 2.1 versus 3.4 FIM total score points per day; p < 0.001). CONCLUSION: The OMT protocol used does not appear to be efficacious in this hospital rehabilitation population.
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