Physiotherapy or Fasciotomy as Treatment for Chronic Exertional Compartment Syndrome in the Lower… (NCT03584815) | Clinical Trial Compass
RecruitingNot Applicable
Physiotherapy or Fasciotomy as Treatment for Chronic Exertional Compartment Syndrome in the Lower Leg?
Denmark72 participantsStarted 2019-05-05
Plain-language summary
It is hypothesized that physiotherapy including a change in running landing pattern and surgical fasciotomy are equally good as treatment options for chronic exertional compartment syndrome (CECS) of the anterior compartment of the lower leg.
The endpoints/outcomes are:
Change from week 0 (start of study) to week 12 (completion of intervention) in: patient reported outcome measure (PROM) (Exercise induced leg pain Questionnaire (EILP)).
Secondary outcomes are: Visual Analogue Scale (VAS) score after an "exercise provocation test": Change in intracompartmental pressure (ICP)Change in muscle compartment compliance. Change in Global Rating of Change Score/Scale (GRC). Change in Single Assessment Numeric Evaluation (SANE)
The study is important because:
1. Results from recent studies suggest that physiotherapy represents a valid alternative to surgery for the treatment of CECS. Surgery is currently standard treatment and a change towards physiotherapy as primary treatment could potentially reduce both complication rates and costs.
2. Intracompartmental pressure (ICP) is gold standard for diagnosing CECS. However, the association between ICP and symptoms of CECS, both before and after physiotherapeutic and surgical treatment, muscle compartment compliance and intracompartmental perfusion, has not been thoroughly investigated.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.