RecruitingNot ApplicableNCT03584815

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

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.


Sponsor

Bispebjerg Hospital

Enrollment

72 participants

Start Date

May 5, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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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Interventions

PROCEDURESurgery/Fasciotomy

Open fasciotomy of the anterior and lateral compartment + standard post-operative physiotherapy for 12 weeks

OTHERPhysiotherapy

Intensive physiotherapy for 12 weeks including a change to forefoot/midfoot strike during running


Locations(2)

Bispebjerg Hospital

Copenhagen, Copehagen, Denmark

Bispebjerg Hospital

Copenhagen, Denmark

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NCT03584815