Clinical trial NCT00685880: Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis
Official title: Randomized, Double Blind Comparison Trial of Prolotherapy (Dextrose) Compared to Corticosteroid Injection for the Treatment of Symptomatic Thumb Carpo-metacarpal Joint Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Thumb Carpometacarpal Joint Osteoarthritis
Keywords: thumb carpo metacarpal joint osteoarthritis
prolotherapy
intra articular steroid
hand therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-05-29
Enrollment: 2
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With a Decreased Pain Score >20%
timeFrame: baseline, 6 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic Physical Medicine & Rehabilitation Residency
name: Michael J. Gruba, M.D.
role: PRINCIPAL_INVESTIGATOR
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