Trial Outcomes & Findings for Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis (NCT NCT00685880)

Results Overview

Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

baseline, 6 month follow-up

Results posted on

2012-08-30

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	0	2
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prolotherapy Group Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.	Corticosteroid Group n=2 Participants Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.	Total n=2 Participants Total of all reporting groups
Age Categorical <=18 years	—	0 participants n=4 Participants	0 participants n=27 Participants
Age Categorical Between 18 and 65 years	—	0 participants n=4 Participants	0 participants n=27 Participants
Age Categorical >=65 years	—	2 participants n=4 Participants	2 participants n=27 Participants
Gender Female	—	2 participants n=4 Participants	2 participants n=27 Participants
Gender Male	—	0 participants n=4 Participants	0 participants n=27 Participants
Region of Enrollment United States	—	2 participants n=4 Participants	2 participants n=27 Participants

PRIMARY outcome

Timeframe: baseline, 6 month follow-up

Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.

Outcome measures

Outcome data not reported

Adverse Events

Prolotherapy Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Corticosteroid Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey S. Brault

Mayo Clinic

Phone: 507-284-1643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place