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临床试验/NCT03584815
NCT03584815招募中不适用

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.

Bispebjerg Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
72
试验地点
1
主要终点
Exercise induced leg pain Questionnaire (EILP)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Surgery/fasciotomy

Active Comparator

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.

干预措施: Surgery/Fasciotomy (Procedure)

Physiotherapy

Active Comparator
  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.

干预措施: Physiotherapy (Other)

结局指标

主要结局

Exercise induced leg pain Questionnaire (EILP)

时间窗: 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.

次要结局

  • Intracompartmental pressure (ICP) testing(12 weeks)
  • Ultrasonic measurement of anterior compartment thickness (ACT)(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Doessing, M.D., PhD

Chief Surgeon. M.D. PhD

Bispebjerg Hospital

研究点 (1)

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