RECRUITING

Managing Chronic Tendon Pain by Metformin

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Managing Chronic Tendon Pain by Repurposing Metformin

Quick Facts

Study Start:2024-05-24
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06100822

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing and able to provide informed consent for participation
  2. * Clinical diagnosis of Achilles tendinopathy
  3. * Pain disability index score of between 20 - 70 points (0-100 scale VISA-A)
  4. * Sonopalpation tenderness with tendon thickening and/or loss of fibrillary architecture.
  5. * Ability to read, speak, and understand English
  1. * Any intervention (corticosteroids or other orthobiologic intervention as injection) to targeted tissue within the last 6 months.
  2. * Previous Achilles tendon surgery.
  3. * Known platelet abnormality or hematological disorder.
  4. * Presence of other conditions that might affect the functional scale of the indexed limb.
  5. * Unwillingness to be randomized.
  6. * Body Mass Index (BMI) greater than 30.
  7. * Occult tear in the indexed tendon.
  8. * Systemic inflammatory disease.
  9. * Use of fluoroquinolone in the past 6 months.
  10. * Subjects must not be pregnant or breastfeeding, or planning to become pregnant or breastfeed during the course of the trial
  11. * Chronic kidney disease (eGFR \<60)
  12. * Diagnosis of diabetes mellitus or elevated HbA1c at screening (\> 6.5)
  13. * Unable to take an oral medication in a non crushable pill form
  14. * Taking metformin presently or within the last 6 months
  15. * History of allergy to metformin
  16. * History of lactic acidosis or elevated lactate at screening (\> 2.2)
  17. * Severe Hepatic dysfunction
  18. * Currently taking a diabetic medication such as sitagliptin, saxagliptin, linagliptin, alogliptin, sitagliptin with metformin
  19. * Currently taking a Carbonic anhydrase inhibitor such as topiramate, zonisamide, acetazolamide, dichlorphenamide, methazolamide
  20. * Currently taking cimetidine

Contacts and Locations

Study Contact

James H Wang, PhD
CONTACT
4126489102
wanghc@pitt.edu

Principal Investigator

James H Wang, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: James Wang

  • James H Wang, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-24
Study Completion Date2025-04

Study Record Updates

Study Start Date2024-05-24
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • Achilles Tendon
  • Metformin
  • Achilles Tendinopathy
  • Chronic Pain

Additional Relevant MeSH Terms

  • Tendinopathy
  • Chronic Pain
  • Achilles Tendinopathy