Managing Chronic Tendon Pain by Metformin
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 he
| Condition(s) | Tendinopathy, Chronic Pain, Achilles Tendinopathy |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * 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. * Ability to read, speak, and understand English Exclusion Criteria: * 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. * Unwillingness to be randomized. * Body Mass Index (BMI) greater than 30. * Occult tear in the indexed tendon. * Syste |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Lead sponsor | James Wang |
| Locations | Pittsburgh, Pennsylvania, United States |
| Start date | 2024-05-24 |
| NCT ID | NCT06100822 |
| Official listing | https://clinicaltrials.gov/study/NCT06100822 |