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.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Bispebjerg Hospital
RECRUITING
Copenhagen
Bispebjerg Hospital
RECRUITING
Copenhagen
Contact Information
Primary
Simon Doessing, M.D. PhD.
simon.doessing.01@regionh.dk
+4538635042
Time Frame
Start Date: 2019-05-05
Estimated Completion Date: 2025-08
Participants
Target number of participants: 72
Treatments
Active_comparator: Surgery/fasciotomy
Fasciotomy of the anterior and lateral compartments in the lower legs:~Two linear longitudinal skin incisions, each approximately 4 cm, are made allowing for excision of the fascia in full length. Sharp dissection to the level of the subcutaneous tissues down to the layer of the overlying fascia is performed, and using a finger or blunt instrument, the subcutaneous tissue is swept away from the fascia, so that an unobstructed cut of the fascia can be performed. The fascia overlying the anterior and lateral compartment is meticulously dissected under direct visualization, the fascia is released approximately as far proximal and distal as the muscle belly is. The perimysium is spared.
Active_comparator: Physiotherapy
1. Change the running pattern to decrease load on the affected muscles of the lower leg including the eccentric work performed by the tibialis anterior during the rear-foot strike.~2. Strengthen the major muscles of all lower leg compartments in order address any muscular imbalance/instability around the ankle joint, and to strengthen the main muscle groups responsible for alignment of the hip and knee.
Related Therapeutic Areas
Sponsors
Leads: Bispebjerg Hospital

This content was sourced from clinicaltrials.gov