Botulism Toxin Injection as a Treatment for Arthritis of the Basal Thumb Joint

September 7, 2017 updated by: University of Missouri-Columbia

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other Names:
  • Botox
  • Botox Cosmetic
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 Names:
  • 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.
Drug: Lidocaine
Single injection of 1 - 3 mL of 2% Lidocaine
Other Names:
  • Xylocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain
Time Frame: twenty-four hours, ten days, twelve weeks, six months, and one year
twenty-four hours, ten days, twelve weeks, six months, and one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Range of Motion
Time Frame: twelve weeks, six months, and one year
twelve weeks, six months, and one year
Strength
Time Frame: twelve weeks, six months, and one year
twelve weeks, six months, and one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Stephen H. Colbert, MD, University of Missouri-Department of Surgery-Division of Plastic Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

January 7, 2010

First Submitted That Met QC Criteria

January 8, 2010

First Posted (ESTIMATE)

January 11, 2010

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1146517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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