Arthritis of the base of the thumb is a common debilitating problem. It is believed that laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be treated by securing the joint surgically or symptoms can be treated with hand therapy and/or injection of corticosteroids. Recently prolotherapy (sugar water) has been shown to decrease looseness of joints and also be...
Date First Received: May 26, 2008
Last Updated: May 28, 2008
Verified by: Mayo Clinic, May 2008
Clinical Trial Phase: N/A | Start Date: May 2008
Overall Status: Recruiting
Estimated Enrollment: 40
Brief Summary
Official Title: “Randomized, Double Blind Comparison Trial of Prolotherapy (Dextrose) Compared to Corticosteroid Injection for the Treatment of Symptomatic Thumb Carpo-Metacarpal Joint Arthritis”
Condition Keyword(s):
Intervention(s):
Arthritis of the base of the thumb is a common debilitating problem. It is believed that laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be treated by securing the joint surgically or symptoms can be treated with hand therapy and/or injection of corticosteroids. Recently prolotherapy (sugar water) has been shown to decrease looseness of joints and also be helpful for hand and knee arthritis. We hypothesize that prolotherapy injections for thumb arthritis will be equally or more beneficial to the patients then steroids.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: July 2009
Detailed Clinical Trial Description
This will be a prospective randomized double blind comparison study comparing Celestone to Dextrose intra-articular injections as adjuncts to hand therapy for the treatment of symptomatic thumb CMC osteoarthritis. Twenty patients will be randomized to each treatment arm to provide enough power to show a 20% change in visual analogue scale (VAS) for pain to be significant. We will also be measuring analgesic use, various grip strength and upper extremity functional assessment scores.
Intervention(s) in this Clinical Trial
- Drug: Prolotherapy (10% dextrose solution)
- Dextrose diluted with sterile water.
- Drug: Corticosteroid solution
- Celestone 6 mg/ml
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Prolotherapy group
- Active Comparator: 2
- Corticosteroid Group
Outcome Measures for this Clinical Trial
Primary Measures
- Decreased pain score >20%.
- Time Frame: 6 month follow-up
Safety Issue?: No
- Time Frame: 6 month follow-up
Secondary Measures
- Analgesic use, grip strength and functional assessment of upper extremities use. Side effects will be recorded if any.
- Time Frame: 6 month
Safety Issue?: Yes
- Time Frame: 6 month
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Age >45
- ability to make follow-up visits over the 6 month protocol
- ability to give informed consent
- Eaton Grad thumb carpo-metacarpal joint osteoarthritis with pain over 3/10 on visual analogue scale with symptoms present greater then 6 months.
Exclusion Criteria:
- Recent trauma to the hand or wrist or fractures eeen on radiographs
- Eaton grade 1 or 4 joints, metabolic bone disease, recent systemic or localized infection (within last 2 weeks)
- history of rheumatologic disease
- allergies to injected solutions
- thumb carpo-metacarpal joint injections in the prior 6 months.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 45 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Mayo Clinic
Overall Clinical Trial Officials and Contacts
Michael J. Gruba, M.D. Principal Investigator Mayo Clinic Physical Medicine & Rehabilitation Residency
Overall Contact: Michael J. Gruba, M.D. 507-284-2511 gruba.michael@mayo.edu
Related Publications
References
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Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00685880
Study ID Number: 07-006348
ClinicalTrials.gov Identifier: NCT00685880
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
