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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
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthritis Multiple Joint
Interventions Drug: Botulinum Toxin Type A
Drug: Steroid - Triamcinolone Acetonide
Drug: Lidocaine
Enrollment 8
Recruitment Details Study had 8 enrollments: 6 completed and 2 withdrew voluntarily. Study was terminated early due to lack of funds. No data analysis was completed.
Pre-assignment Details 8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group.
Arm/Group Title Arthritis Treatment
Hide Arm/Group Description

Participants received one of three treatments:

  • Botulism 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
  • Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine
  • Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution
Period Title: Overall Study
Started 8
Completed 6
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Arthritis Treatment
Hide Arm/Group Description

Participants received one of three treatments:

  • Botulism 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
  • Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine
  • Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
8
 100.0%
Male
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Pain
Hide Description [Not Specified]
Time Frame twenty-four hours, ten days, twelve weeks, six months, and one year
Hide Outcome Measure Data
Hide Analysis Population Description
8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. Data was not collected or analyzed.
Arm/Group Title Arthritis Treatment
Hide Arm/Group Description:

Participants received one of three treatments:

  • Botulism 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
  • Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine
  • Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Range of Motion
Hide Description [Not Specified]
Time Frame twelve weeks, six months, and one year
Hide Outcome Measure Data
Hide Analysis Population Description
8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. Data was not collected or analyzed.
Arm/Group Title Arthritis Treatment
Hide Arm/Group Description:

Participants received one of three treatments:

  • Botulism 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
  • Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine
  • Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Strength
Hide Description [Not Specified]
Time Frame twelve weeks, six months, and one year
Hide Outcome Measure Data
Hide Analysis Population Description
8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. Data was not collected or analyzed.
Arm/Group Title Arthritis Treatment
Hide Arm/Group Description:

Participants received one of three treatments:

  • Botulism 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
  • Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine
  • Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arthritis Treatment
Hide Arm/Group Description

Participants received one of three treatments:

  • Botulism 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
  • Lidocaine: Single injection of 1 - 3 mL of 2% Lidocaine
  • Triamcinolone Acetonide: Single injection of 1 - 3 mL of 40mg/mL Triamcinolone acetonide solution

    8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group.

All-Cause Mortality
Arthritis Treatment
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arthritis Treatment
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arthritis Treatment
Affected / at Risk (%)
Total   0/8 (0.00%) 
The study was terminated early due to lack of funds and no data was analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Stephen Colbert
Organization: University of Missouri-Columbia
Phone: 573-882-2275
Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01045694     History of Changes
Other Study ID Numbers: 1146517
First Submitted: January 7, 2010
First Posted: January 11, 2010
Results First Submitted: May 18, 2017
Results First Posted: July 13, 2017
Last Update Posted: October 6, 2017