Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis
NCT ID: NCT00685880
Last Updated: 2012-08-30
Study Results
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View full resultsBasic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2008-05-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Prolotherapy group
Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
Prolotherapy (10% dextrose solution)
Dextrose diluted with sterile water.
Corticosteroid Group
Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
Betamethasone
CELESTONE® SOLUSPAN® \* (betamethasone injectable suspension) Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate. Subjects will receive a 0.25 to 0.5 mL Celestone Soluspan injection.
Interventions
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Prolotherapy (10% dextrose solution)
Dextrose diluted with sterile water.
Betamethasone
CELESTONE® SOLUSPAN® \* (betamethasone injectable suspension) Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate. Subjects will receive a 0.25 to 0.5 mL Celestone Soluspan injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to make follow-up visits over the 6 month protocol
* Ability to give informed consent
* Eaton grade 2-3 thumb carpo-metacarpal joint osteoarthritis with pain over 3/10 on visual analogue scale with symptoms present greater then 6 months.
Exclusion Criteria
* Eaton grade 1, or 4 joints affected
* 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.
45 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Mayo Clinic
Principal Investigators
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Michael J. Gruba, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic Physical Medicine & Rehabilitation Residency
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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Other Identifiers
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07-006348
Identifier Type: -
Identifier Source: org_study_id