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Regenerative Injection Therapy and Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
Réseau de Santé Vitalité Health Network
ClinicalTrials.gov Identifier:
NCT01206634
First received: September 17, 2010
Last updated: September 20, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Knee Arthrosis
 Procedure: Regenerative injection therapy
Behavioral: Exercise
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Regenerative Injection Therapy on Function and Pain in Patients With Knee Osteoarthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Réseau de Santé Vitalité Health Network:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    This self-administered questionnaire assesses pain, disability and joint stiffness using 24 items with 5-point Likert scales.


Secondary Outcome Measures:
  • Brief Pain Inventory (short form) [ Time Frame: Every 4 weeks from week 0 to 36. ] [ Designated as safety issue: Yes ]
  • Wong-Baker Faces Pain Rating Scale [ Time Frame: Every 4 weeks from week 0 to 36. ] [ Designated as safety issue: Yes ]
  • Timed Up-and-Go Test [ Time Frame: Every 4 weeks from week 0 to 36. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 45
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Behavioral: 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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  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206634

Sponsors and Collaborators
Réseau de Santé Vitalité Health Network
Investigators
Principal Investigator: Richard Dumais, MD Dr. Georges-L.-Dumont Regional Hospital, Vitalité Health Network
  More Information

No publications provided

Responsible Party: Dr Richard Dumais, anastesiologist, Réseau de Santé Vitalité Health Network
ClinicalTrials.gov Identifier: NCT01206634     History of Changes
Other Study ID Numbers: HC-9427-B2716-21C
Study First Received: September 17, 2010
Last Updated: September 20, 2010
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Osteoarthritis, Knee
 Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013