Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis

This study has been terminated.
(Unable to recruit adequate numbers of patients)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00685880
First received: May 26, 2008
Last updated: July 27, 2012
Last verified: July 2012
Results First Received: July 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Thumb Carpometacarpal Joint Osteoarthritis
Interventions: Drug: Prolotherapy (10% dextrose solution)
Drug: Betamethasone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the pool of referrals to the Mayo Hand Clinic who are interested in receiving an injection for their pain, agree to comply with the standardized hand therapy program, meet the inclusion/exclusion criteria and are able to make the scheduled follow-up visits from Mayo 2008 to July 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Prolotherapy Group Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
Corticosteroid Group Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.

Participant Flow:   Overall Study
    Prolotherapy Group     Corticosteroid Group  
STARTED     0     2  
COMPLETED     0     2  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Prolotherapy Group Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
Corticosteroid Group Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
Total Total of all reporting groups

Baseline Measures
    Prolotherapy Group     Corticosteroid Group     Total  
Number of Participants  
[units: participants]
  0     2     2  
Age  
[units: participants]
     
<=18 years         0     0  
Between 18 and 65 years         0     0  
>=65 years         2     2  
Gender  
[units: participants]
     
Female         2     2  
Male         0     0  
Region of Enrollment  
[units: participants]
     
United States         2     2  



  Outcome Measures

1.  Primary:   Number of Participants With a Decreased Pain Score >20%   [ Time Frame: baseline, 6 month follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination due to low enrollment; no subject data was analyzed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jeffrey S. Brault
Organization: Mayo Clinic
phone: 507-284-1643
e-mail: brault.jeffrey@mayo.edu


Publications:
Reeves, K. (2000). Prolotherapy: Basic Science, Clinical Studies, and Technique. Pain Procedures in Clinical Practice. T. A. Lennard. Philadelphia, PA, Hanley and Belfus, INC.: 172-90.


Responsible Party: Michael Joseph Gruba M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00685880     History of Changes
Other Study ID Numbers: 07-006348
Study First Received: May 26, 2008
Results First Received: July 27, 2012
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board