Managing Chronic Tendon Pain by Metformin
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorJames Wang
About this trial
The purpose of the current exploratory clinical trial is to determine the effect of oral ingestion of metformin (OIM) in non-diabetic patients with chronic Achilles tendon pain. The trial has two aims; 1) to assess the effects of OIM treatment on tendon pain, and 2) to determine the effects of OIM capsules on tendon healing and repair. Twenty participants will be treated with metformin capsules for 16 weeks combined with a home exercise program. A comparison group of 20 participants will be treated with placebo tablets along with home exercise program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to provide informed consent for participation
Clinical diagnosis of Achilles tendinopathy
Pain disability index score of between 20 - 70 points (0-100 scale VISA-A)
Sonopalpation tenderness with tendon thickening and/or loss of fibrillary architecture.
Disqualifiers
Any intervention (corticosteroids or other orthobiologic intervention as injection) to targeted tissue within the last 6 months.
Previous Achilles tendon surgery.
Known platelet abnormality or hematological disorder.
Presence of other conditions that might affect the functional scale of the indexed limb.
Trial design
Design model
Parallel
Treatments tested in this trial
Metformin
Drug500 mg capsules of Metformin Extended Release
Placebo
Drug500 mg capsules of placebo pills
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Placebo Group, Placebo CapsulesPlacebo comparator 1 intervention
Group B: Treatment Group, Metformin CapsulesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) Score
The VISA-A is a self-administered questionnaire that asks about Achilles tendon pain, function, and activity. Scores range from 0 to 100 with a low score indicating more severe pain.
Time frame
baseline, 4 weeks, 16 weeksSecondary outcomes
1
Change in VAS score
The VAS is a self-administered questionnaire that asks about pain. Scores range from 0 to 10 with a high score indicating more severe pain.
Time frame
baseline, 4 weeks, 16 weeks2
Change in tendon thickness
Images of the Achilles tendon in long axis will be acquired using B-mode ultrasound imaging. Maximum Achilles tendon thickness (mm) will be measured by a blinded investigator.
Time frame
baseline, 4 weeks, 16 weeks3
Change in tendon cross-sectional area
Images of the Achilles tendon in short axis will be acquired using B-mode ultrasound imaging. Maximum Achilles tendon cross-sectional area (mm\^2) will be measured by a blinded investigator.
Time frame
baseline, 4 weeks, 16 weeks4
Change in tendon neovascularization
Achilles tendon neovascularization will be evaluated using the 5-point modified Ohberg scale: 0 - no vessels visible 1. one vessel, mostly anterior to the tendon 2. one or two vessels throughout the tendon 3. three vessels throughout the tendon 4. more than three vessels throughout the tendon
Time frame
baseline, 4 weeks, 16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
James Wang
Lead sponsor
University of Pittsburgh
Sponsor institution
United States Department of Defense
Collaborator
Source ClinicalTrials.gov