Botulism Toxin Injection as a Treatment for Arthritis of the Basal Thumb Joint
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|ClinicalTrials.gov Identifier: NCT01045694|
Recruitment Status : Terminated (Unable to acquire additional funding needed to continue this study.)
First Posted : January 11, 2010
Results First Posted : July 13, 2017
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Arthritis Multiple Joint||Drug: Botulinum Toxin Type A Drug: Steroid - Triamcinolone Acetonide Drug: Lidocaine||Phase 4|
Purpose: Basal joint arthritis, or carpometacarpal (CMC) osteoarthritis, of the thumb is very common, particularly in the elderly. Morbidities include pain, decreased range of motion, and decreased strength. Nonsurgical treatments for CMC arthritis include oral analgesics, splinting, and steroid injection. In multiple recent trials, botulinum toxin A (BTX-A) injection has been shown to be an efficacious nonsurgical option for osteoarthritis of large joints, including those that have failed steroid injections. To our knowledge, the efficacy of BTX-A injection in thumb CMC arthritis has not been examined.
Methods: Patients with a clinical and radiographic diagnosis of basal joint arthritis who are appropriate and willing candidates for injection therapy will be selected. The primary symptom indicating need for injection would be pain not controlled with more conservative measures (e.g. nonsteroidal anti-inflammatory drugs (NSAIDs), splinting, physical therapy, etc.) Weakness and impaired functioning are also considered. Exclusion criteria will include any injection within the last 12 months or surgical treatment. All patients will undergo Eaton staging radiographically prior to treatment. Informed consent will be obtained and patients will be randomly assigned to one of three groups. One group will receive BTX-A injections, the second group will receive triamcinolone plus lidocaine injections, and the third group will receive saline plus lidocaine injections of the thumb CMC joint. Prior to treatment, patients' baseline function will be assessed with pinch, grip, and range of motion measurements, and the affect of their disease will be measured with a visual analog pain scale and the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Pain scales and DASH questionnaires will be completed at twenty-four hours, ten days, twelve weeks, six months, and one year after treatment. Pain scales will be recorded for average pain and maximum pain. Clinical evaluations with pinch, grip, and range of motion measurements will occur ten days, twelve weeks, six months, and one year after treatment. All patients will be asked to return when sufficient symptoms recur to warrant further treatment.
Expected Results: We hypothesize that BTX-A injection will have equal or better efficacy than steroid injection for the treatment of basal joint arthritis.
Expected Conclusion: No study to date has examined BTX-A as a treatment for basal joint arthritis. Some patients are not surgical candidates and are reliant on non-surgical treatments for pain control and maintenance of function. BTX-A has shown to be effective in treating osteoarthritis of larger joints that undergo frequent use, including cases resistant to steroid injections. The basal thumb joint also undergoes frequent use and is often resistant to steroid injection. We believe that BTX-A will provide another efficacious non-surgical option for treatment of the CMC joint of the thumb. We estimate that the study will require approximately three to four years to achieve adequate patient numbers for each group.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Botulinum Toxin Versus Steroid Injection for Basal Joint Arthritis of the Thumb: a Randomized, Double Blind, Placebo-controlled Clinical Trial|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||October 2015|
Experimental: Botulinum Toxin Type A
Arm investigates the efficacy of Botulinum Toxin A injection for the treatment of basal thumb joint arthritis
Drug: Botulinum Toxin Type A
One-time injection of 50 units of Botulinum Toxin A suspended in 2 mL of normal saline, with approximately 1 mL injected or sufficient quantity to fill joint capsule
Active Comparator: Steroid - Triamcinolone Acetonide
Arm uses the standard of care - Steroid injection - as an active comparator to the experimental injection of Botulinum Toxin A for the treatment of basal thumb joint arthritis
Drug: Steroid - Triamcinolone Acetonide
Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution
Other Name: Kenalog-40
Placebo Comparator: Lidocaine
Arm uses plain lidocaine injection to serve as a baseline for evaluating the efficacy of Botulinum toxin as compared to steroid injection for the treatment of basal thumb joint arthritis.
Single injection of 1 - 3 mL of 2% Lidocaine
Other Name: Xylocaine
- Pain [ Time Frame: twenty-four hours, ten days, twelve weeks, six months, and one year ]
- Range of Motion [ Time Frame: twelve weeks, six months, and one year ]
- Strength [ Time Frame: twelve weeks, six months, and one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045694
|United States, Missouri|
|University of Missouri|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Stephen H. Colbert, MD||University of Missouri-Department of Surgery-Division of Plastic Surgery|