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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
Sponsor:
Information provided by (Responsible Party):
Simon Doessing, M.D., PhD, Bispebjerg Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Compartment Syndrome Nontraumatic Lower Leg Procedure: Surgery/Fasciotomy Other: Physiotherapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Procedure: Surgery/Fasciotomy
Open fasciotomy of the anterior and lateral compartment + standard post-operative physiotherapy for 12 weeks

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.
Other: Physiotherapy
Intensive physiotherapy for 12 weeks including a change to forefoot/midfoot strike during running




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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 criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Simon Doessing, M.D. PhD. +4538635042 simon.doessing.01@regionh.dk

Locations
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Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Copehagen, Denmark, 2400
Contact: Simon Doessing, M.D. PhD         
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Simon Doessing, M.D. PhD    +4535316089    simondoessing@gmail.com   
Contact: Michael Kjaer, M.D. PhD    +4535316089    Michael.Kjaer@regionh.dk   
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
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Principal Investigator: Simon Doessing, M.D. PhD Institute of Sports Medicine, Bispebjerg Hospital

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Responsible Party: Simon Doessing, M.D., PhD, Chief Surgeon. M.D. PhD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03584815     History of Changes
Other Study ID Numbers: H-18001263
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Compartment Syndromes
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases