Managing Chronic Tendon Pain by Repurposing Metformin
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- James Wang
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) Score
研究概览
简要总结
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.
详细描述
This is a blinded and randomized controlled trial that focuses on the treatment effects of metformin (Met) on chronic tendon pain, healing, and repair in midportion Achilles tendinopathy. We will include a total 40 patients randomly divided into two equal groups:
Group 1: Home Exercise Program + Placebo as a control group
Group 2: Home Exercise Program + Oral Ingestion of Metformin
Patients in group 1 will receive placebo capsules,1 capsule (500 mg) daily for week one, 2 capsules (1,000 mg) daily for week two, 3 capsules daily for week 3 (1,500 mg), and 4 capsules daily (2,000 mg) for weeks 4-16. Patients in group 2 will receive metformin capsules,1 capsule (500 mg) daily for week one, 2 capsules (1,000 mg) daily for week two, 3 capsules daily for week 3 (1,500 mg), and 4 capsules daily (2,000 mg) for weeks 4-16. All patients will participate in a home exercise program through MedBridge, a HIPAA-compliant participant portal currently used by physical therapists at University of Pittsburgh Medical Center. There are 3 visits for this study. Visits include a Screening/Baseline visit, week 4 and week 16 visit. During each visit, participants will answer questions, complete functional testing, and undergo an ultrasound of the Achilles Tendon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Occult tear in the indexed tendon.
- •Systemic inflammatory disease.
- •Use of fluoroquinolone in the past 6 months.
- •Subjects must not be pregnant or breastfeeding, or planning to become pregnant or breastfeed during the course of the trial
- •Chronic kidney disease (eGFR <60)
- •Diagnosis of diabetes mellitus or elevated HbA1c at screening (> 6.5)
- •Unable to take an oral medication in a non crushable pill form
- •Taking metformin presently or within the last 6 months
- •History of allergy to metformin
- •History of lactic acidosis or elevated lactate at screening (> 2.2)
- •Severe Hepatic dysfunction
- •Currently taking a diabetic medication such as sitagliptin, saxagliptin, linagliptin, alogliptin, sitagliptin with metformin
- •Currently taking a Carbonic anhydrase inhibitor such as topiramate, zonisamide, acetazolamide, dichlorphenamide, methazolamide
- •Currently taking cimetidine
研究组 & 干预措施
Placebo Group, Placebo Capsules
Placebo Group (n=20) Week 1: One placebo capsule (500 mg) daily Week 2: Two placebo capsules (1,000 mg) daily Week 3: Three placebo capsules (1,500 mg) daily Week 4-16: Four placebo capsules (2,000 mg) daily
干预措施: Placebo (Drug)
Treatment Group, Metformin Capsules
Treatment Group (n=20) Week 1: One metformin ER capsule (500 mg) daily Week 2: Two metformin (ER) capsules (1,000 mg) daily Week 3: Three metformin (ER) capsules (1,500 mg) daily Week 4-16: Four metformin (ER) capsules (2,000 mg) daily
干预措施: Metformin (Drug)
结局指标
主要结局
Change in Victorian Institute of Sport Assessment - Achilles (VISA-A) Score
时间窗: baseline, 4 weeks, 16 weeks
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.
次要结局
- Change in tendon hypoechogenicity(baseline, 4 weeks, 16 weeks)
- Change in maximum number of heel raises(baseline, 4 weeks, 16 weeks)
- Change in heel raise height(baseline, 4 weeks, 16 weeks)
- Change in heel raise work(baseline, 4 weeks, 16 weeks)
- Change in counter movement jump height(baseline, 4 weeks, 16 weeks)
- Change in drop counter movement jump height(baseline, 4 weeks, 16 weeks)
- Change in VAS score during hopping(baseline, 4 weeks, 16 weeks)
- Change in VAS score(baseline, 4 weeks, 16 weeks)
- Change in tendon thickness(baseline, 4 weeks, 16 weeks)
- Change in tendon cross-sectional area(baseline, 4 weeks, 16 weeks)
- Change in tendon neovascularization(baseline, 4 weeks, 16 weeks)
- Change in counter movement jump height(baseline, 4 weeks, 16 weeks)
- Change in drop counter movement jump height(baseline, 4 weeks, 16 weeks)
- Change in VAS score during hopping(baseline, 4 weeks, 16 weeks)
- Change in tendon hypoechogenicity(baseline, 4 weeks, 16 weeks)
- Change in maximum number of heel raises(baseline, 4 weeks, 16 weeks)
- Change in heel raise height(baseline, 4 weeks, 16 weeks)
- Change in heel raise work(baseline, 4 weeks, 16 weeks)