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RecruitingNCT03584815Updated Nov 2, 2026

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

An interventional study of Surgery/Fasciotomy and Physiotherapy in Compartment Syndrome Nontraumatic Lower Leg, sponsored by Bispebjerg Hospital. Recruiting at 2 sites in Denmark. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2019; still recruiting 7 years 6 months later.
Updated Nov 2, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.
Read the detailed description

CECS of the lower leg is a condition of pain induced by exercise. CECS accounts for 14-33% of lower leg pain in athletes, evenly divided among males and females. Symptoms are described as a tight, cramp like ache that occurs at a well-defined and reproducible point in the exercise bout and increases if the training persists. Relief of symptoms typically occurs within 30 minutes of ending the activity.

The anterior compartment is most commonly affected, followed by the deep posterior, the lateral and the superficial posterior compartment. Often more than one compartment in the same leg is involved, and the condition is reported bilateral in up to 95% of affected athletes.

The pathophysiology of CECS is not fully understood. It is, however, generally agreed that exercise induces abnormal elevation in ICP, which interferes with tissue perfusion and cause painful ischemia affecting the nerves and impairing muscle function. A noncompliant muscle compartment, which is unresponsive to the expansion of muscle volume that occurs with exercise, offer a possible pathophysiological explanation for CECS. However, this view is challenged by a study reporting no difference in fascial thickness and stiffness between CECS patients and healthy controls. Furthermore, the thickness of the anterior compartment increased more with exercise in CECS patients relative to controls, questioning decreased compliance as the main pathophysiology in CECS. The definition of a pathologically elevated ICP during exercise is important for the diagnosis of CECS and is currently debated. The criteria suggested by Pedowitz is used as standard by most clinicians for the diagnosis of CECS: 1) a pre-exercise pressure of 15 mmHg or greater, and/or 2) a 1-minute post-exercise pressure of 30 mmHg or greater, and/or 3) a 5-minute post-exercise pressure of 20 mmHg or greater. The precision and diagnostic value of these commonly used criteria is debated, due to a reported overlap in ICP readings between patients and healthy controls at certain time points. Interestingly, in a small cohort of asymptomatic rollerskiers ICP was elevated, according to the Pedowitz criteria, in 100% of participants after 20 minutes of exercise. Despite these uncertainties, it is suggested that ICP measured 1-minute after ceasing exercise has the highest diagnostic value, as it most consistently display higher values in patients with CECS symptoms relative to healthy controls. The different types of catheters (slid catheter, side-port, straight-needle) also clearly influence the absolute values of the measurements and the catheter tip can be wrongfully placed outside the compartment by experienced health professionals in up to 21% of cases when positioned without ultrasound guidance.

Non-invasive modalities such as magnetic resonance imaging (MRI), near infrared spectroscopy (NIRS) and ultrasound measurements have been suggested as future adjuncts or alternatives for diagnosing CECS, but their diagnostic value remains to be established.

In summary, it is generally agreed that ICP measurements are important for diagnosing CECS, but several studies question current practice including the mentioned criteria and particularly the use of non-ultrasound guided catheter positioning.

Both conservative and surgical treatment options are suggested in the literature.

Conservative treatment, including physiotherapy, has been attempted with varying success and is generally believed by many to be insufficient for the long-term treatment of CECS. However, inducing muscle hypotrophy via injection of botulinum toxin, was efficient in reducing exercise induced pain in CECS patients, but also resulted in decreased muscle strength, although without measurable functional consequences. Interestingly, changing the gait pattern in order to achieve a forefoot/midfoot strike during running, which potentially decrease pressure in the anterior compartment and eccentric load of the anterior compartment muscles has proven successful for treatment of anterior CECS. These studies suggest a role for non-operative treatment of CECS, but to our knowledge, no randomized controlled studies exist regarding the effect of physiotherapy or other non-surgical interventions.

Surgical fasciotomy, with release of the compartment(s) with elevated intra-compartmental pressure, has been shown by many investigators to be effective using both open, mini-open and endoscopically assisted techniques. There are, however, considerable variations in the reported outcomes of surgery. In a large cohort, 45% had symptom recurrence after surgery and 16% experienced surgical complications including infection, neurological damage, and hematoma. Moreover, the need for revision surgery can be as high as 11%. Other groups report more successful outcome of surgery with patient satisfaction of 60 to 90%, including a retrospective follow-up study, in which operation was successful in 81% of patients and non-operative treatment successful in only 41% of patients.

CECS is a common condition in athletes and although disagreements exist, the diagnosis is typically made based on a history of pain in the calf muscles during exercise that resolves within 30 minutes of ending the activity as well as a positive ICP reading. Typically the patients are offered fasciotomy if the symptoms persist.

No studies have compared the effect of fasciotomy to any non-surgical treatment strategies in a randomized controlled setting. Moreover, correlation between symptom severity, ICP measurements, muscle compartment compliance and perfusion, and effect of treatment is not fully elucidated. Finally, the possible effect of changing the landing pattern in combination with physical therapy has not been attempted in a randomized setting.

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.
02

Conditions studied

  • Compartment Syndrome Nontraumatic Lower Leg

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03

In context

Compartment Syndromes

52 studies on the registry are indexed under Compartment Syndromes; 8 are open to participants now.

This study's planned enrollment of 72 is above the median of 42 across 31 interventional studies indexed under Compartment Syndromes.

Browse Compartment Syndromes studies →

Lead sponsor

Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureSurgery/Fasciotomy

    Open fasciotomy of the anterior and lateral compartment + standard post-operative physiotherapy for 12 weeks

  • OtherPhysiotherapy

    Intensive physiotherapy for 12 weeks including a change to forefoot/midfoot strike during running

06

What researchers measure

Primary outcomes

  1. Exercise induced leg pain Questionnaire (EILP)

    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.

    Time frame: 1 year

Secondary outcomes

  1. Intracompartmental pressure (ICP) testing

    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.

    Time frame: 12 weeks

  2. Ultrasonic measurement of anterior compartment thickness (ACT)

    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.

    Time frame: 12 weeks

07

Study locations

2 of 2 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started May 2019 (actual). Primary completion is estimated for Aug 2027, 99 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 2, 2026: primary completion Aug 2026 → Aug 2027 and completion Aug 2027 → Aug 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 30, 2018
First posted
Jul 12, 2018
StartActual
May 5, 2019
Primary completionEst.
Aug 2027was Aug 2026
CompletionEst.
Aug 2028was Aug 2027
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Aug 2026→Aug 2027
Nov 2, 2026
Study completion
Aug 2027→Aug 2028
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Primary completion Aug 2026→Aug 2027
    Study completion Aug 2027→Aug 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03584815
Responsible party
Simon Doessing, M.D., PhD (Chief Surgeon. M.D. PhD, Bispebjerg Hospital) — Principal investigator
First posted
Jul 12, 2018
Start date
May 5, 2019
Primary completion
Aug 2027 (estimated)
Completion
Aug 2028 (estimated)
Last update
Nov 2, 2026

Study contacts

Simon Doessing, M.D. PhD.
Contact
simon.doessing.01@regionh.dk
+4538635042
Simon Doessing, M.D. PhD
principal investigator · Institute of Sports Medicine, Bispebjerg Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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