Tendinopathy Education on the Achilles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Fear of Movement
研究概览
简要总结
This is a randomized double-blind, placebo-controlled trial with individuals who have chronic Achilles tendinopathy (AT). This study investigates the effects of education on outcomes (specified in hypotheses below) related to participation in an exercise program. Participants will be randomized to one of two educational programs. All participants will receive the same exercise intervention. This study will consent and randomize 66 participants, who will complete 2 in-person evaluation sessions (baseline, 8-week follow-up), 8 treatment sessions with a physical therapist (between baseline and 8-week follow-up), and 1 online evaluation sessions (12-week follow-up).
We hypothesize that 1) a biopsychosocial approach to education will decrease pain (NPRS) and disability (PROMIS physical function) more than the standard of care for patients with AT, 2) exercise will improve all three pain mechanisms examined in this RCT (increased PPT, decreased kinesiophobia, increased number of heel raises).
详细描述
This feasibility randomized controlled trial was designed to address the following aims:
Specific Aim 1 examines if education on central pain mechanisms (i.e. biopsychosocial approach) compared to education on peripheral pain mechanisms (i.e. standard of care utilizing a biomedical approach) is more effective at reducing pain and disability in a pilot RCT exercise program for Achilles tendinopathy. We hypothesize that a biopsychosocial approach to education will decrease pain (NPRS) and disability (PROMIS physical function) more than the standard of care for patients with AT.
Specific Aim 2 determines which central pain mechanisms (nociplastic pain, pain psychology, motor dysfunction) are improved by an exercise program, regardless of education group. We hypothesize that exercise will improve all three central pain mechanisms (increased PPT, decreased kinesiophobia, increased number of heel raises).
A total of 66 adults with chronic Achilles tendinopathy (AT) will be enrolled (consented and randomized) in this single-site pilot randomized controlled trial (RCT). All data will be collected at a single site within an academic medical center. A pilot RCT comparing effectiveness of exercise with pain education to standard of care, i.e. exercise with biomedical education. Participants will be randomized to treatment group using a permuted block randomization scheme stratified by sex and AT type (insertional and midportion). Participants will complete up to 7 treatment sessions over an 8-week period. With an anticipated 10% dropout rate, we plan to analyze data on 30 adults with chronic AT per group.
Participants will complete 2 evaluation sessions at baseline and 8-week follow-up. Evaluation sessions will involve the following 4 types of testing.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded to type of education program Outcomes assessor will be blinded to treatment group allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary source of pain localized to Achilles tendon insertion or midportion
- •Localized pain at least 3/10 in the Achilles tendon (midportion, insertion, unilateral or bilateral) during walking, heel raises, or hopping
- •Pain that increases (>1 point on 11-point scale) with increasing load
排除标准
- •Younger than 18 years of age
- •Inability to read and write in English
- •Achilles tendon pain for less than 3 months
- •History of Achilles tendon rupture that was verified with surgical or conservative management
- •History of invasive intervention (surgery, tenex) for AT on more painful side
- •Non-invasive treatment (physical therapy, nitroglycerine patch, iontophoresis, injection) for AT in the past 3 months
- •Diagnosed with systemic inflammatory conditions (e.g. rheumatoid arthritis, ankylosing spondylitis), endocrine disorder with complications (e.g. Uncontrolled Type I or II diabetes, Diabetic peripheral neuropathy), connective tissue disorder (e.g. Marfan's syndrome)
- •Cardiovascular conditions that may be exacerbated by a 90 second submersion of hand in cold water (Raynaud's, cold contact uticaria)
- •History of taking fluoroquinolones within the past 3 months
- •History of corticosteroid injection to foot/ankle/leg within the past 3 months
- •Foot and ankle pain primarily due to other pathology, such as posterior impingement, bursitis, paratendonitis, sural nerve injury, ankle osteoarthritis, or radicular/referred symptoms (pain, altered sensation, weakness, altered reflexes) from lumbar spine into lower extremities
- •Four step square test >15 seconds
- •Additional exclusion criteria for online only visits:
- •Unable to successfully complete virtual visits with a webcam and/or Prefer only in-person visits
- •Virtual Fall risk assessment: Stay Independent score >4[56]
- •Symptoms indicating need for in-person blood pressure monitoring: 1) Inconsistent use of HTN meds, and/or 2) any recent/current associated symptoms with uncontrolled HTN
研究组 & 干预措施
Pain Education + Exercise
The goals of the pain education intervention are for patients to 1) address fear of movement and pain catastrophizing specific to AT, 2) learn about the neurophysiology of pain, 3) develop coping skills, and 4) promote exercise participation through pacing. This program enables patients to have a conceptual change in their understanding of what causes pain, gain greater control over the psychological aspects of pain, and reduce the perceived threat of chronic pain.
All participants will receive the same progressive Achilles tendon loading exercise program.
干预措施: Pain Education and Exercise (Other)
Standard Education + Exercise
The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage.
All participants will receive the same progressive Achilles tendon loading exercise program.
干预措施: Standard Education and Exercise (Other)
结局指标
主要结局
Fear of Movement
时间窗: Pre-Intervention, Post-intervention (8-weeks, 12-weeks)
Tampa Scale of Kinesiophobia (TSK) rates current level of fear about movement causing pain and injury. Scores range from 17, indicating negligible fear of movement, to 68, indicating extreme fear of pain with movement.
Self-reported Function (Aim 1)
时间窗: Pre-Intervention, Post-intervention (8-week follow-up, 12-week follow-up)
Self-reported function will be assessed with the PROMIS physical function computer adaptive test, which has a mean score of 50 and standard deviation of 10 in the general population. A higher score indicates better physical function.
Nociplastic Pain- CPM (Aim 2)
时间窗: Pre-Intervention, Post-intervention (8-weeks)
Conditioned pain modulation (CPM) at the Achilles tendon will be calculated as the % change in the pain pressure threshold (PPT) with the hand in cold water (conditioning stimulus) compared to the (PPT) room temperature water.
Pain (Aim 1)
时间窗: Pre-Intervention, Post-intervention (8-week follow-up)
Participants will rate pain using the numeric pain rating scale (NPRS, 11-pt scale from 0 to 10 as worst pain imaginable) during 3 single limb heel raises
Performance-based Function: Heel Raises
时间窗: Pre-Intervention, Post-intervention (8-weeks)
Plantarflexor endurance will be quantified with the maximum number of repetitions of single limb heel raises
次要结局
未报告次要终点
研究者
Ruth Chimenti
Assistant Professor
University of Iowa