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Physiotherapy or Fasciotomy as Treatment for Chronic Exertional Compartment Syndrome in the Lower Leg?

RecruitingNAAges 18 Years - 50 YearsAllBispebjerg Hospital
NCT03584815 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Surgery/Fasciotomy
  • Physiotherapy
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Where

2 sites
Bispebjerg Hospital
Copenhagen, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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