Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis
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Purpose
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 than steroids.
| Condition | Intervention |
|---|---|
|
Thumb Carpometacarpal Joint Osteoarthritis |
Drug: Prolotherapy (10% dextrose solution) Drug: Betamethasone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized, Double Blind Comparison Trial of Prolotherapy (Dextrose) Compared to Corticosteroid Injection for the Treatment of Symptomatic Thumb Carpo-metacarpal Joint Arthritis |
- Number of Participants With a Decreased Pain Score >20% [ Time Frame: baseline, 6 month follow-up ] [ Designated as safety issue: No ]Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.
| Enrollment: | 2 |
| Study Start Date: | May 2008 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Prolotherapy group
Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
|
Drug: Prolotherapy (10% dextrose solution)
Dextrose diluted with sterile water.
|
|
Active Comparator: Corticosteroid Group
Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
|
Drug: 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 Name: Celestone Soluspan
|
Detailed Description:
Dextrose prolotherapy has been shown to decrease anterior cruciate ligament (ACL) laxity and decrease knee joint pain. Similar to ACL laxity leading to knee osteoarthritis, laxity of the "beak" ligament can lead to worsening thumb CMC osteoarthritis. We hypothesize that dextrose intra-articular prolotherapy will have similar results in treating the pain and instability related to symptomatic thumb CMC osteoarthritis. 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 utilize the ultrasound guided injection protocol described by the co-investigators for both treatment arms to ensure proper placement of the respective solutions. We will measure various grip strengths, and VAS pain scales prior to the first injection, prior to the second injection at 6 weeks and at the final visit at 6 months. A telephone follow-up with pain scale will be administered at 3 months. A Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire measuring upper extremity functional impairment will be obtained at initial and final visits.
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age >45
- 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:
- Recent trauma to the hand or wrist or fractures eeen on radiographs
- 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.
Contacts and Locations| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55902 | |
| Principal Investigator: | Michael J. Gruba, M.D. | Mayo Clinic Physical Medicine & Rehabilitation Residency |
More Information
Additional Information:
Publications:
| Responsible Party: | Michael Joseph Gruba M.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00685880 History of Changes |
| Other Study ID Numbers: | 07-006348 |
| Study First Received: | May 26, 2008 |
| Results First Received: | July 27, 2012 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
thumb carpo metacarpal joint osteoarthritis prolotherapy intra articular steroid hand therapy |
Additional relevant MeSH terms:
|
Arthritis Osteoarthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Betamethasone-17,21-dipropionate Betamethasone Betamethasone acetate phosphate Betamethasone sodium phosphate Anti-Inflammatory Agents Therapeutic Uses |
Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013