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

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated April 6, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Aug 2024 to Aug 2026
    • Study completion date: Aug 2025 to Aug 2027
    v8
  2. Minor Re-verified, no change to tracked fieldsv7
  3. Notable Primary completion date: Aug 2023 to Aug 2024
    • Study completion date: Aug 2024 to Aug 2025
    v6
  4. Notable Primary completion date: Aug 2021 to Aug 2023
    • Study completion date: Aug 2022 to Aug 2024
    v5
  5. Minor Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2018 to May 5, 2019
    • Study sites: 0 to 2
    v3
  2. Minor Eligibility criteria shortened, about 18 words
    • Study description shortened, about 237 words
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03584815
Lead Sponsor Bispebjerg Hospital
Conditions
(from sponsor)
Compartment Syndrome Nontraumatic Lower Leg
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov