Radial Extracorporeal Shock Wave Treatment (rESWT) of Myofascial Pain Syndrome in Low Back Pain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of treatment of radial shockwave in myofascial pain syndrome in the lumbar region compared to placebo through questionnaires and imaging exams.

Detailed Description
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BACKGROUND: Extracorporeal shockwave treatment has been used widely for musculoskeletal conditions, however no randomized controlled trial are available about its use for chronic low back pain with myofascial pain syndrome (MPS). HYPOTHESIS: Radial extracorporeal shockwave treatment (rESWT) improves pain intensity and functional disability compared with placebo in patients with chronic low back pain due to MPS. STUDY DESIGN: Randomized controlled clinical trial METHODS: A prospective, randomized, double-blind, placebo-controlled study will be carried out on 40 patients who has moderate to severe pain (VAS > 4) for more than 6 months, despite 6 weeks of conservative treatment with antidepressants associated with rehabilitation. Six interventions of rESWT (3-4 bar; 1000 impulses per trigger point (TP) or 2500 impulses per muscle) will be compared with placebo. The outcome measures were pain visual analogue scale (VAS), Oswestry Disability Index, Short-form McGill Pain Questionnaire, Roland Morris Disability Questionnaire and the temperature of the treated area will be evaluated with Thermography. The assessments will be apply before treatment, after conservative treatment, 6 and 12 weeks after rESWT.

Official Title
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Prospective, Comparative, Randomized Study of the Effectiveness of Shock Wave Treatment in Myofascial Pain Syndrome in Low Back Pain

Conditions
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Myofascial Pain Syndromes, Low Back Pain, Lumbago

Intervention / Treatment
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* Device: Swiss DolorClast® CLASSIC applicator
* Device: Swiss DolorClast® CLASSIC placebo applicator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presenting clinical complaints of lumbar and / or gluteal pains for 3 months or more Display pain of moderate to severe intensity: visual analogue scale (VAS)> 4 Diagnosis of myofascial pain syndrome in the lumbar and / or gluteal Authorize in writing the term of free and informed consent to participate in the study Availability of frequent attendance at hospital Exclusion Criteria: Organic or psychological disorders that contraindication participation of patients in study Metabolic, infectious, oncological or rheumatologic disorders Fibromyalgia Labor dispute Indication for surgery in column Contraindications to therapy of shock waves: Coagulopathy and / or anticoagulant Pregnancy Acute infection in soft tissue or bone Systemic Infections Presence of ulcers at treatment sites Presence of larger vessels or nerves at treatment sites Polyneuropathies Malignancies Cardiac arrhythmias or use of pacemaker Epilepsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radial Extracorporeal Shock Wave<br>Swiss DolorClast® CLASSIC applicator | Device: Swiss DolorClast® CLASSIC applicator<br>* Radial Extracorporeal Shock Wave applicator use in 6 sessions with 1 week of interval, 1000 impulses per myofascial trigger point, 5 to 7 hertz frequency, 2 to 4 bar pressure<br>|
| Placebo Comparator: Placebo<br>Swiss DolorClast® CLASSIC placebo applicator | Device: Swiss DolorClast® CLASSIC placebo applicator<br>* Placebo applicator, use in 6 sessions with 1 week of interval, 1000 impulses per myofascial trigger point, 5 to 7 hertz frequency, 2 to 4 bar pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of pain relief by visual analogue scale (VAS) of radial extracorporeal shock waves in myofascial pain syndrome in the lumbar and gluteal region compared to placebo | The outcome will be assessed by Visual Analogue Scale (VAS) | 12 weeks after the last session of shockwave | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myofascial Pain Syndromes, Myofascial Trigger Point, Low Back Pain, Lumbago, Shock Waves, High-Energy, High-Energy Shock Waves, Interdisciplinary Health Team, Multidisciplinary Pain Centers