NCT01206634|CompletedPhase 4
Regenerative Injection Therapy and Osteoarthritis
Effect of Regenerative Injection Therapy on Function and Pain in Patients With Knee Osteoarthritis
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Effect of Regenerative Injection Therapy on Function and Pain in Patients With Knee Osteoarthritis
Sponsor study identifier
interventional
45
0 countries
N/A
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2008
Actual (reported)Study Completion
October 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
October 2008
Actual (reported)October 2008
Actual (reported)September 17, 2010
Actual (reported)September 22, 2010
Actual (reported)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
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.
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
Richard Dumais, MD
Dr. Georges-L.-Dumont Regional Hospital, Vitalité Health Network
45 participants (actual enrollment reported by the registry).
First Submitted
September 17, 2010
First Posted
September 22, 2010
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Exercise Effect on Aerobic Capacity and QOL in Heart Failure
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 2008
Actual (reported)Study Completion
October 2008
Actual (reported)Last Updated
September 22, 2010
Record last verified: 2010-09
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Source: ClinicalTrials.gov.
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