Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
NCT03584815

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

Led by Bispebjerg Hospital · Updated on 2026-04-06

72

Participants Needed

2

Research Sites

430 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 50 years
  • Symptoms for more than 3 months
  • Symptoms from both legs with pain (cramp-like, tight, burning, or pressure) in the anterior lower leg starting after about 10 minutes of exercise
  • Pain worsened with prolonged lower leg exertion
  • Majority of pain relieved within 30 minutes of rest
Not Eligible

You will not qualify if you...

  • Previous fasciotomy in the lower leg
  • History of serious trauma to the lower leg (fracture, muscle or tendon rupture)
  • ASA physical status classification greater than 2
  • Clinical symptoms of unilateral anterior CECS or lateral/posterior CECS
  • Clinical symptoms of lumbar spine radiculopathy, periostitis/shin splint, stress fracture, popliteal artery entrapment syndrome, isolated peroneal nerve entrapment, or isolated muscle fascia herniation

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Bispebjerg Hospital

Copenhagen, Copehagen, Denmark, 2400

Actively Recruiting

2

Bispebjerg Hospital

Copenhagen, Denmark, 2400

Actively Recruiting

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Research Team

S

Simon Doessing, M.D. PhD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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