Thumb Carpometacarpal Joint Osteoarthritis
Conditions
Keywords
thumb carpo metacarpal joint osteoarthritis, prolotherapy, intra articular steroid, hand therapy
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.
Interventions
DRUGProlotherapy (10% dextrose solution)
Dextrose diluted with sterile water.
DRUGBetamethasone
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the pool of referrals to the Mayo Hand Clinic who are interested in receiving an injection for their pain, agree to comply with the standardized hand therapy program, meet the inclusion/exclusion criteria and are able to make the scheduled follow-up visits from Mayo 2008 to July 2010.
Participants by arm
| Arm | Count |
|---|---|
| Prolotherapy Group Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint. | 0 |
| Corticosteroid Group Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Corticosteroid Group | Total |
|---|---|---|
| Age Categorical <=18 years | 0 participants | 0 participants |
| Age Categorical >=65 years | 2 participants | 2 participants |
| Age Categorical Between 18 and 65 years | 0 participants | 0 participants |
| Gender Female | 2 participants | 2 participants |
| Gender Male | 0 participants | 0 participants |
| Region of Enrollment United States | 2 participants | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 2 |
| serious Total, serious adverse events | 0 / 0 | 0 / 2 |
Outcome results
Primary
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.
Time frame: baseline, 6 month follow-up