Physiotherapy or Fasciotomy as Treatment for Chronic Exertional Compartment Syndrome in the Lower Leg?
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|ClinicalTrials.gov Identifier: NCT03584815|
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 31, 2019
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:
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Compartment Syndrome Nontraumatic Lower Leg||Procedure: Surgery/Fasciotomy Other: Physiotherapy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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.|
|Actual Study Start Date :||May 5, 2019|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2022|
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.
Open fasciotomy of the anterior and lateral compartment + standard post-operative physiotherapy for 12 weeks
Active Comparator: Physiotherapy
Intensive physiotherapy for 12 weeks including a change to forefoot/midfoot strike during running
- Exercise induced leg pain Questionnaire (EILP) [ Time Frame: 1 year ]The primary outcome is 10-item uni-dimensional PROM, the "Exercise induced leg pain Questionnaire" (EILP) (Nauck, Lohrer, Padhiar, & King, 2015). Each item is scored on a five point Likert scale from 4 (no difficulty) to 0 (unable to do) with a total score of 40 points. This PROM is developed specifically to quantify the patients perceived severity of exercise induced lower leg symptoms and has a high validity and reliability. We have translated the original German version of the questionnaire into Danish for the purpose of the present study. The translation is in accordance with international standards (Beaton, Bombardier, Guillemin, & Ferraz, 2000) and have been approved by the authors of the original German version.
- Intracompartmental pressure (ICP) testing [ Time Frame: 12 weeks ]Following treadmill running until symptoms occur with pain reaching 8 on a visual analogue scale (VAS) the patients are positioned supine with a soft pad under the knee, and the knee in 10 degrees flexion and the ankle relaxed in 30 degree plantar-flexion, confirmed with a goniometer. The catheter is inserted at a 90 degree angle with ultrasound guidance to insure correct positioning. To save time, ultrasound is performed before exercise is begun to get the approximate position of the compartments, and the skin is anesthetised, specifically avoiding anesthetizing deep to the skin, using a 23g needle and 0.5% lidocain. Compartment pressure is measured immediately after exercise, after 1-minute and after 5 minutes . We use the handheld Stryker Intracompartmental Monitor System with an 18g side-ported needle (Stryker) as described by Braver. This equipment has proven both accurate and reliable.
- Ultrasonic measurement of anterior compartment thickness (ACT) [ Time Frame: 12 weeks ]The thickness of the anterior compartment is determined at rest and 0.5 min., 2.5 min., and 4.5 min after treadmill running (described above). The patients are positioned in the same supine position (see above). As described by Rajasekaran (Rajasekaran et al., 2013), ACT is measured at 20% of the distance from the head of the fibula to the lateral tip of the lateral malleolus. The site of measurement is located and marked on the skin prior to exercise provocation. Using Hitachi Avius ultrasound machine (Hitachi Aloka, Tokyo, Japan) with a linear array transducer and general musculoskeletal settings. The ultrasound probe is positioned at an approximated 90-degree angle to the anterior muscle group and parallel to the interosseous membrane. The thickness of the anterior muscle group is determined by measuring the shortest distance from the border of the interosseous membrane facing the anterior compartment and the interior border of the fascia adjacent to the subcutaneous fat.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584815
|Contact: Simon Doessing, M.D. PhD.||+firstname.lastname@example.org|
|Copenhagen, Copehagen, Denmark, 2400|
|Contact: Simon Doessing, M.D. PhD|
|Copenhagen, Denmark, 2400|
|Contact: Simon Doessing, M.D. PhD +4535316089 email@example.com|
|Contact: Michael Kjaer, M.D. PhD +4535316089 Michael.Kjaer@regionh.dk|
|Principal Investigator:||Simon Doessing, M.D. PhD||Institute of Sports Medicine, Bispebjerg Hospital|