Comparing physiotherapy and surgery for chronic leg pain in athletes
Is Physiotherapy or Fasciotomy the Best Treatment Option for Chronic Exertional Compartment Syndrome in the Anterior Compartment of the Lower Leg? A Randomized Controlled Trial.
This study tests whether physiotherapy can help athletes with chronic leg pain just as well as surgery can.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Bispebjerg Hospital Academic / other |
| Locations | 2 sites (Copenhagen, Copehagen and 1 other locations) |
| Trial ID | NCT03584815 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of physiotherapy versus surgical fasciotomy for treating chronic exertional compartment syndrome (CECS) in the lower leg. Participants will undergo either treatment and be monitored for changes in pain and muscle function over a 12-week period. The primary outcome will be assessed using a patient-reported outcome measure, while secondary outcomes will include various pain and muscle compliance assessments. The goal is to determine if physiotherapy can serve as a viable alternative to surgery for this condition.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 50 who have experienced symptoms of CECS for more than three months and have pain in both legs during exercise.
Not a fit: Patients with a history of lower leg trauma or those with unilateral symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-surgical treatment option for patients suffering from chronic exertional compartment syndrome.
How similar studies have performed: Recent studies suggest that physiotherapy may be a valid alternative to surgery for CECS, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Age between 18 and 50 years * Symptoms for more than 3 months * Symptoms from both legs. Pain (cramp like, tight, burning or pressure) in the anterior part of the lower leg starting after approximately 10 minutes of exercise * Pain worsened with prolonged lower extremity exertion * Majority of pain relieved within 30 minutes of rest. Exclusion criteria: * Previous fasciotomy in the lower leg * History of serious trauma involving the lower leg (fracture, muscle/tendon rupture) * ASA (America Association of Anaesthesiologists Classification of Physical Health) \> 2 * Clinical symptoms consistent with unilateral anterior CECS or lateral and posterior CECS * Clinical symptoms consistent with lumbar spine radiculopathy, periostit/shin-splint, stress fracture, popliteal artery entrapment syndrome, isolated peroneal nerve entrapment, with isolated muscle fascia herniation.
Where this trial is running
Copenhagen, Copehagen and 1 other locations
- Bispebjerg Hospital — Copenhagen, Copehagen, Denmark (Recruiting)
- Bispebjerg Hospital — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Simon Doessing, M.D. PhD — Institute of Sports Medicine, Bispebjerg Hospital
- Study coordinator: Simon Doessing, M.D. PhD.
- Email: simon.doessing.01@regionh.dk
- Phone: +4538635042
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.