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Completed

NCT Number: NCT01835795

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

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.

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Key information

Conditions

Myofascial Pain Syndromes Back Pain Low Back Pain Lumbago Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, 05403-010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swiss DolorClast® CLASSIC applicator

Device

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 applicator

Device

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

Primary outcomes

  1. 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

    Time frame: 12 weeks after the last session of shockwave

    The outcome will be assessed by Visual Analogue Scale (VAS)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Apr 19, 2013
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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