A multicentre randomised, 1-year comparative effectiveness, parallel-group trial protocol of a physical therapy approach compared to corticosteroid injections

Deyle, Gail D., Gill, Norman W., Rhon, Daniel I., Allen, Chris S., Allison, Stephen C., Hando, Ben R., Petersen, Evan J., Dusenberry, Douglas I. and Bellamy, Nicholas (2016) A multicentre randomised, 1-year comparative effectiveness, parallel-group trial protocol of a physical therapy approach compared to corticosteroid injections. BMJ Open, 6 3: 1-11. doi:10.1136/bmjopen-2015-010528


Author Deyle, Gail D.
Gill, Norman W.
Rhon, Daniel I.
Allen, Chris S.
Allison, Stephen C.
Hando, Ben R.
Petersen, Evan J.
Dusenberry, Douglas I.
Bellamy, Nicholas
Title A multicentre randomised, 1-year comparative effectiveness, parallel-group trial protocol of a physical therapy approach compared to corticosteroid injections
Journal name BMJ Open   Check publisher's open access policy
ISSN 2044-6055
Publication date 2016
Year available 2016
Sub-type Article (original research)
DOI 10.1136/bmjopen-2015-010528
Open Access Status DOI
Volume 6
Issue 3
Start page 1
End page 11
Total pages 11
Place of publication London, United Kingdom
Publisher BMJ Group
Collection year 2017
Language eng
Formatted abstract
Introduction Corticosteroid injections (CSIs) are commonly used as an initial or a primary intervention for knee osteoarthritis (OA). Consistent evidence indicates CSIs offer symptom relief with conflicting reports regarding long-term efficacy. Physical therapy (PT) offers a non-invasive alternative. There is moderate evidence suggesting short-term and long-term symptom relief and functional improvement with PT interventions. Patients with knee OA are more commonly prescribed CSI than PT prior to total joint replacement. UnitedHealthcare and Military Health System data show substantially more total knee replacement patients receive preoperative CSI than PT. There are no studies comparing CSI to a PT approach in individuals with knee OA. The primary objective of this study is to compare the effectiveness of CSI to PT in individuals with knee OA at 1, 2 and 12 months.

Methods and analysis
We plan to recruit 156 participants meeting established knee OA criteria. Following informed consent, participants will be randomised to receive either CSI or PT. All participants will receive instruction on recommended exercise and weight control strategies plus usual medical care. The CSI intervention consisting of 3 injections and the PT intervention consisting of 8–12 sessions will be spaced over 12 months. Measures of the dependent variables (DVs) will occur at baseline, 4 weeks, 8 weeks, 6 months and 12 months post enrolment. This pragmatic, randomised clinical trial will be a mixed-model 2×5 factorial design. The independent variables are treatment (CSI and PT) and time with five levels from baseline to 1 year. The primary DV is the Western Ontario & McMaster Universities Arthritis Index (WOMAC). We will also compare healthcare utilisation between the 2 groups.

Ethics and Dissemination The protocol was approved by the Madigan Army Medical Center Institutional Review Board. The authors intend to publish the results in a peer-reviewed source.

Trial Registration Number NCT01427153.
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: HERDC Pre-Audit
Admin Only - School of Medicine
School of Medicine Publications
 
Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 1 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 0 times in Scopus Article
Google Scholar Search Google Scholar
Created: Tue, 26 Apr 2016, 02:23:30 EST by System User on behalf of School of Medicine