Regenerative Injection Therapy and Osteoarthritis
Effect of Regenerative Injection Therapy on Function and Pain in Patients With Knee Osteoarthritis
1 other identifier
interventional
45
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2007
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 17, 2010
CompletedFirst Posted
Study publicly available on registry
September 22, 2010
CompletedSeptember 22, 2010
September 1, 2010
1 year
September 17, 2010
September 20, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Western Ontario and McMaster Universities Osteoarthritis Index of severity of osteoarthrosis symptoms (WOMAC version 3.1)
This self-administered questionnaire assesses pain, disability and joint stiffness using 24 items with 5-point Likert scales.
Every 4 weeks from week 0 to 36
Secondary Outcomes (3)
Brief Pain Inventory (short form)
Every 4 weeks from week 0 to 36.
Wong-Baker Faces Pain Rating Scale
Every 4 weeks from week 0 to 36.
Timed Up-and-Go Test
Every 4 weeks from week 0 to 36.
Study Arms (2)
Regenerative injection therapy
EXPERIMENTALExercise
ACTIVE COMPARATORInterventions
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.
the exercise program consists of 4 strengthening exercises for which participants are asked to perform 3 sets of 10 repetitions daily
Eligibility Criteria
You may qualify if:
- have had a diagnosis of knee arthrosis,
- experience pain in the knee for a minimum of six months,
- be capable to understand and execute physiotherapy exercises,
- be 18 years or older.
You may not qualify if:
- previous operation of the referring knee,
- infection of the skin surrounding the knee or of the articulation,
- abnormal coagulation,
- allergy to lidocaine,
- pregnancy,
- breast feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Dumais, MD
Dr. Georges-L.-Dumont Regional Hospital, Vitalité Health Network
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 17, 2010
First Posted
September 22, 2010
Study Start
October 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
September 22, 2010
Record last verified: 2010-09