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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorBispebjerg Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Surgery/Fasciotomy
  • Physiotherapy

Treatment groups

72 Participants
are divided into 2 treatment groups

Sponsors and collaborators