Arthritis Multiple JointPhase 4NCT01045694
Botulism Toxin Injection as a Treatment for Arthritis of the Basal Thumb Joint
A Phase 4 study testing Botulinum Toxin Type A, Steroid - Triamcinolone Acetonide and Lidocaine in people with Arthritis Multiple Joint, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis Multiple Joint
- What is being tested?
- Botulinum Toxin Type A, Steroid - Triamcinolone Acetonide and Lidocaine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiographic evidence of basal joint arthritis
- Associated symptoms of basal joint arthritis including:
- Pain
- Decreased range of motion
- Decreased thumb strength
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Arthritis Multiple Joint
- Being tested
- Botulinum Toxin Type A, Steroid - Triamcinolone Acetonide, Lidocaine
- Keywords
- Carpometacarpal Joints, Osteoarthritis, Basal thumb joint arthritis, Trapeziometacarpal arthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botox Cosmetic, Botox
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
Steroid - Triamcinolone AcetonideDrug
Also called Kenalog-40
Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution
LidocaineDrug
Also called Xylocaine
Single injection of 1 - 3 mL of 2% Lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Type A | Experimental | Arm investigates the efficacy of Botulinum Toxin A injection for the treatment of basal thumb joint arthritis Receives: Drug: Botulinum Toxin Type A |
| Steroid - Triamcinolone Acetonide | Active comparator | 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 Receives: Drug: Steroid - Triamcinolone Acetonide |
| Lidocaine | Placebo comparator | 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. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: twenty-four hours, ten days, twelve weeks, six months, and one year
Secondary outcomes (2)
Range of Motion
Measured: twelve weeks, six months, and one year
Strength
Measured: twelve weeks, six months, and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startMar 2011
- Primary completionAug 2012
- Study completionOct 2015
Why it stopped: Unable to acquire additional funding needed to continue this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthritis Multiple JointStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen H. Colbert, MD, Principal investigator, University of Missouri-Department of Surgery-Division of Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045694
- Sponsor's protocol ID
- 1146517
- Status last verified
- Sep 2017
- First submitted
- 7 Jan 2010
- Last updated
- 6 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Versus Steroid Injection for Basal Joint Arthritis of the Thumb: a Randomized, Double Blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01045694
- Acronym / sponsor ID
- 1146517
- Conditions
- Arthritis Multiple Joint
- Keywords
- Carpometacarpal Joints, Osteoarthritis, Basal thumb joint arthritis, Trapeziometacarpal arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to acquire additional funding needed to continue this study.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Jan 2010 (estimated)
- Results
- Posted 13 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A | Experimental | Drug: Botulinum Toxin Type AArm investigates the efficacy of Botulinum Toxin A injection for the treatment of basal thumb joint arthritis |
| Steroid - Triamcinolone Acetonide | Active comparator | Drug: Steroid - Triamcinolone AcetonideArm 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 |
| Lidocaine | Placebo comparator | Drug: LidocaineArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Radiographic evidence of basal joint arthritis
- Associated symptoms of basal joint arthritis including:
- Pain
- Decreased range of motion
- Decreased thumb strength
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type AAlso: Botox Cosmetic, BotoxOne-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 | Drug | Botulinum Toxin Type A |
| Steroid - Triamcinolone AcetonideAlso: Kenalog-40Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution | Drug | Steroid - Triamcinolone Acetonide |
| LidocaineAlso: XylocaineSingle injection of 1 - 3 mL of 2% Lidocaine | Drug | Lidocaine |
Primary outcome
Pain
Time frame: twenty-four hours, ten days, twelve weeks, six months, and one year
2 secondary outcomes
Range of Motion
Time frame: twelve weeks, six months, and one year
Strength
Time frame: twelve weeks, six months, and one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen H. Colbert, MD principal investigator
University of Missouri-Department of Surgery-Division of Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type A, Steroid - Triamcinolone Acetonide and Lidocaine in people with Arthritis Multiple Joint, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: twenty-four hours, ten days, twelve weeks, six months, and one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.