Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis

NCT00685880 | Terminated Results

• 1 other identifier: 07-006348
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thumb Carpometacarpal Joint Osteoarthritis

Keywords

thumb carpo metacarpal joint osteoarthritis; prolotherapy; intra articular steroid; hand therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Decreased Pain Score >20%

  Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.

  baseline, 6 month follow-up

Study Arms (2)

Prolotherapy group

EXPERIMENTAL

Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.

Drug: Prolotherapy (10% dextrose solution)

Corticosteroid Group

ACTIVE COMPARATOR

Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.

Drug: Betamethasone

Interventions

Prolotherapy (10% dextrose solution) DRUG

Dextrose diluted with sterile water.

Prolotherapy group

Betamethasone DRUG

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.

Also known as: Celestone Soluspan

Corticosteroid Group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

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MeSH Terms

Interventions

Prolotherapy; Betamethasone; betamethasone acetate phosphate

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

Early termination due to low enrollment; no subject data was analyzed.

Results Point of Contact

• Title: Dr. Jeffrey S. Brault
• Organization: Mayo Clinic

brault.jeffrey@mayo.edu

507-284-1643

Study Officials

• Michael J. Gruba, M.D.

  Mayo Clinic Physical Medicine & Rehabilitation Residency

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 26, 2008
• First Posted: May 29, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 30, 2012
• Results First Posted: August 30, 2012

Record last verified: 2012-07

Locations

US (1)