Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis

Not Applicable

Terminated

• Conditions: Thumb Carpometacarpal Joint Osteoarthritis
• Interventions: Drug: Prolotherapy (10% dextrose solution); Drug: Betamethasone

• Registration Number: NCT00685880
• Lead Sponsor: Mayo Clinic

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-26
• Study First Submitted QC: 2008-05-28
• Study First Posted: 2008-05-29
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-07
• Results First Submitted: 2012-07-27
• Results First Submitted QC: 2012-07-27
• Last Update Submitted: 2012-07-27
• Results First Posted: 2012-08-30
• Last Update Posted: 2012-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prolotherapy group	Prolotherapy (10% dextrose solution)	Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
Corticosteroid Group	Betamethasone	Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Decreased Pain Score >20%	baseline, 6 month follow-up	Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States