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

University of Sao Paulo46 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Myofascial Pain Syndromes Low Back Pain Lumbago

Interventions

Swiss DolorClast® CLASSIC applicatorDEVICE

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

Swiss DolorClast® CLASSIC placebo applicatorDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, Brazil

Outcomes

Primary Outcomes

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)

Time frame: 12 weeks after the last session of shockwave

Data from ClinicalTrials.gov

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