Regenerative Injection Therapy and Osteoarthritis
The objective is to assess the effectiveness of regenerative injection therapy (RIT) to relieve pain and restore function in patients with knee osteoarthritis.
The study design is a randomized controlled trial with cross-over. 40 patients with chronic knee osteoarthritis will be randomly assigned to receive exercise therapy for 32 weeks in combination with RIT on weeks 0, 4, 8, and 12 or exercise therapy for 32 weeks combined to RIT on weeks 20, 24, 28 and 32. The primary outcome is the WOMAC score.
|Knee Arthrosis||Procedure: Regenerative injection therapy Behavioral: Exercise||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Effect of Regenerative Injection Therapy on Function and Pain in Patients With Knee Osteoarthritis|
- Western Ontario and McMaster Universities Osteoarthritis Index of severity of osteoarthrosis symptoms (WOMAC version 3.1) [ Time Frame: Every 4 weeks from week 0 to 36 ]This self-administered questionnaire assesses pain, disability and joint stiffness using 24 items with 5-point Likert scales.
- Brief Pain Inventory (short form) [ Time Frame: Every 4 weeks from week 0 to 36. ]
- Wong-Baker Faces Pain Rating Scale [ Time Frame: Every 4 weeks from week 0 to 36. ]
- Timed Up-and-Go Test [ Time Frame: Every 4 weeks from week 0 to 36. ]Measure of patients mobility. Patients start sitting on a chair, they then stand, walk a short distance, turn around, and come back to sit on the chair again. Score = Time to complete the task.
|Study Start Date:||October 2007|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
|Experimental: Regenerative injection therapy||
Procedure: Regenerative injection therapy
Injections of 1cc of a 15% dextrose and 0.6% lidocaine solution free of adrenaline in each of eight administration sites in the collateral ligaments and a 5 cc injection of a 20% dextrose and 0.5% lidocaine without adrenaline solution inside the knee joint.
|Active Comparator: Exercise||
the exercise program consists of 4 strengthening exercises for which participants are asked to perform 3 sets of 10 repetitions daily
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01206634
|Principal Investigator:||Richard Dumais, MD||Dr. Georges-L.-Dumont Regional Hospital, Vitalité Health Network|