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Trial record 82 of 272 for:    Betamethasone

Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis

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ClinicalTrials.gov Identifier: NCT00685880
Recruitment Status : Terminated (Unable to recruit adequate numbers of patients)
First Posted : May 29, 2008
Results First Posted : August 30, 2012
Last Update Posted : August 30, 2012
Sponsor:
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Thumb Carpometacarpal Joint Osteoarthritis
Interventions Drug: Prolotherapy (10% dextrose solution)
Drug: Betamethasone
Enrollment 2
Recruitment Details 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  
Arm/Group Title Prolotherapy Group Corticosteroid Group
Hide Arm/Group Description Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint. Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
Period Title: Overall Study
Started 0 2
Completed 0 2
Not Completed 0 0
Arm/Group Title Prolotherapy Group Corticosteroid Group Total
Hide Arm/Group Description Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint. Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint. Total of all reporting groups
Overall Number of Baseline Participants 0 2 2
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 2 participants 2 participants
<=18 years 0 0
Between 18 and 65 years 0 0
>=65 years 2 2
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 2 participants 2 participants
Female 2 2
Male 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 2 participants 2 participants
2 2
1.Primary Outcome
Title Number of Participants With a Decreased Pain Score >20%
Hide Description Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.
Time Frame baseline, 6 month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prolotherapy Group Corticosteroid Group
Hide Arm/Group Description:
Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Subjects will be followed for adverse events for six months following the intervention.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prolotherapy Group Corticosteroid Group
Hide Arm/Group Description Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint. Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
All-Cause Mortality
Prolotherapy Group Corticosteroid Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Prolotherapy Group Corticosteroid Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prolotherapy Group Corticosteroid Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/2 (0.00%) 
Early termination due to low enrollment; no subject data was analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jeffrey S. Brault
Organization: Mayo Clinic
Phone: 507-284-1643
EMail: brault.jeffrey@mayo.edu
Publications:
Hackett, G. (1956). Ligament and Tendon Relaxation Treated by Prolotherapy. Springfield, IL, Charles C Thomas.
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.
Layout table for additonal information
Responsible Party: Michael Joseph Gruba M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00685880     History of Changes
Other Study ID Numbers: 07-006348
First Submitted: May 26, 2008
First Posted: May 29, 2008
Results First Submitted: July 27, 2012
Results First Posted: August 30, 2012
Last Update Posted: August 30, 2012