N/A
N=66
Tendinopathy Education on the Achilles
Achilles Tendinopathy
Bottom Line
View on ClinicalTrials.gov: NCT04059146 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Pain (Aim 1) — 4.9; 5.2; 1.8; 1.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pain Education and Exercise (Other); Standard Education and Exercise (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ruth Chimenti
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain (Aim 1) |
4.9; 5.2; 1.8; 1.5 | — |
| PRIMARY Self-reported Function (Aim 1) |
49.3; 47.3; 51.0; 50.1; 52.4; 51.2 | — |
| PRIMARY Nociplastic Pain- CPM (Aim 2) |
24.0; 28.1; 16.6; 13.3 | — |
| PRIMARY Fear of Movement |
37.2; 37.7; 29.4; 32.6; 29.8; 32.3 | — |
| PRIMARY Performance-based Function: Heel Raises |
15.0; 18.1; 22.3; 21.1 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04059146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.