Phase 3
N=46
Achilles Pain Block
Achilles Tendon Pain
Bottom Line
View on ClinicalTrials.gov: NCT03316378 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Central Sensitization — 463.5; 383.6; 425.7; 358.0 kilopascal — p=0.44
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ropivacaine injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ruth Chimenti
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Central Sensitization |
463.5; 383.6; 425.7; 358.0 | 0.44 |
| PRIMARY Pain Psychology |
37.2; 29.6; 34.9; 28.7 | <0.001 sig |
| PRIMARY Movement System |
2.7; 3.0; 2.8; 2.8 | 1.0 |
Summary
The purpose of this study is to better understand how the peripheral and central nervous system interact to produce the sensation of pain and motor patterns in patients with achilles tendinopathy (AT). These findings will motivate the development of future clinical studies that incorporate knowledge about pain processing and movement strategies in patients with tendinopathy. Participants with achilles tendinopathy will receive an anesthetic injection to the achilles tendon in order to examine how reduced pain, detected by the peripheral nervous system, alters task performance and perception of pain. We hypothesize that there are factors within the central nervous system that contribute to continued pain and disability in patients with chronic AT.
Eligibility Criteria
For patients with AT
Inclusion Criteria
- Clinical diagnosis of chronic (>3 months) AT, consisting of pain with pressure at the achilles tendon and report of pain that is aggravated by physical activity
Exclusion Criteria
- History of foot or ankle surgery, bilateral lateral epicondyle tendinopathy
- Comorbidity that would be aggravated by placing hand in water (Raynaud's, thoracic outlet syndrome)
- Comorbidity (e.g. stroke, neurological disorder) that limits ability to participate in exercise
- Comorbidity (e.g. rheumatic disease, fibromyalgia) that contributes to pain with activity
- Peripheral neuropathy
- Previous adverse response to a local anesthetic injection
- Are pregnant
- Are a ballroom dancer
For control participants
Inclusion Criteria
- Sex, Age and BMI-matched to participant with AT
Exclusion Criteria
- No history of tendinopathy
- No condition that limited activity in the past 6 months
- History of foot or ankle surgery, bilateral lateral epicondyle tendinopathy
- Comorbidity that would be aggravated by placing hand in water (Raynaud's, thoracic outlet syndrome)
- Comorbidity (e.g. stroke, neurological disorder) that limits ability to participate in exercise
- Comorbidity (e.g. rheumatic disease, fibromyalgia) that contributes to pain with activity
- Peripheral neuropathy
- Are pregnant
- Are a ballroom dancer
Data sourced from ClinicalTrials.gov (NCT03316378). 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.