Botulism Toxin Injection as a Treatment for Arthritis of the Basal Thumb Joint
| Status: | Terminated |
|---|---|
| Conditions: | Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/8/2017 |
| Start Date: | March 2011 |
| End Date: | October 2015 |
Botulinum Toxin Versus Steroid Injection for Basal Joint Arthritis of the Thumb: a Randomized, Double Blind, Placebo-controlled Clinical Trial
Basal arthritis of the thumb is a common condition with increased prevalence in
post-menopausal women, obese persons, and the elderly. Surgical options are varied and
efficacious, but not all patients are candidates for surgery. The successes and pitfalls of
previous, similar trials are carefully considered in the creation of our own. Though steroid
injection is the standard of care in basal joint arthritis, current data does not support its
efficacy beyond placebo effect. No trial has yet examined the efficacy of botulinum toxin
type A (BTX-A) injection into the basal thumb joint nor compared it to steroid. Since
efficacy of steroid is questionable at best, our hope is that BTX-A injection of the basal
joint might be the next great tool in treating this common, debilitating disease.
post-menopausal women, obese persons, and the elderly. Surgical options are varied and
efficacious, but not all patients are candidates for surgery. The successes and pitfalls of
previous, similar trials are carefully considered in the creation of our own. Though steroid
injection is the standard of care in basal joint arthritis, current data does not support its
efficacy beyond placebo effect. No trial has yet examined the efficacy of botulinum toxin
type A (BTX-A) injection into the basal thumb joint nor compared it to steroid. Since
efficacy of steroid is questionable at best, our hope is that BTX-A injection of the basal
joint might be the next great tool in treating this common, debilitating disease.
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.
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.
Inclusion Criteria:
- Radiographic evidence of basal joint arthritis
- Associated symptoms of basal joint arthritis including:
- Pain
- Decreased range of motion
- Decreased thumb strength
Exclusion Criteria:
- Persons under the age of 18
- Women who are currently pregnant
- Incompetent persons or persons otherwise incapable of effectively communicating the
subjective experience of pain
- Prior surgery on the joint
- Injection in the last 12 months
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