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

Not Applicable

Completed

• Conditions: Myofascial Pain Syndromes; Low Back Pain; Lumbago
• Interventions: Device: Swiss DolorClast® CLASSIC placebo applicator; Device: Swiss DolorClast® CLASSIC applicator

• Registration Number: NCT01835795
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01-07
• Study First Submitted: 2013-04-14
• Study First Submitted QC: 2013-04-18
• Study First Posted: 2013-04-19
• Primary Completion: 2018-03-19
• Study Completion: 2019-01-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-27
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Swiss DolorClast® CLASSIC placebo applicator	Swiss DolorClast® CLASSIC placebo applicator
Radial Extracorporeal Shock Wave	Swiss DolorClast® CLASSIC applicator	Swiss DolorClast® CLASSIC applicator

Primary Outcome Measures

Name	Time	Method
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	12 weeks after the last session of shockwave	The outcome will be assessed by Visual Analogue Scale (VAS)

Trial Locations

Locations (1)

IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP; 🇧🇷 Sao Paulo, Brazil