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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Myofascial Pain Syndromes; Myofascial Trigger Point; Low Back Pain; Lumbago	Device: Radial Extracorporeal Shock Wave; Device: Placebo	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Prospective, Comparative, Randomized Study of the Effectiveness of Shock Wave Treatment in Myofascial Pain Syndrome in Low Back Pain
Study Start Date :	January 2013
Estimated Primary Completion Date :	December 2014
Estimated Study Completion Date :	January 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Radial Extracorporeal Shock Wave; Radial Extracorporeal Shock Wave applicator	Device: Radial Extracorporeal Shock Wave; Radial Extracorporeal Shock Wave applicator use in 6 sessions with 1 week of interval, 1000 impulses per myofascial trigger point, 10 to 15 hertz frequency, 2 to 4 bar pressure; Other Name: Swiss DolorClast® CLASSIC applicator
Placebo Comparator: Placebo; Placebo applicator	Device: Placebo; Placebo applicator, use in 6 sessions with 1 week of interval, 1000 impulses per myofascial trigger point, 10 to 15 hertz frequency, 2 to 4 bar pressure; Other Name: Swiss DolorClast® CLASSIC placebo applicator

Outcome Measures

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Primary Outcome Measures :

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: 6 weeks after the last session of shockwave results will be measured ]
   The outcome will be assessed by Visual Analogue Scale (VAS)

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Brazil
IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP	Recruiting
Sao Paulo, Brazil, 05403-010
Contact: Ricardo Kobayashi koba@globo.com
Principal Investigator: Ricardo Kobayashi

Sponsors and Collaborators

University of Sao Paulo

Investigators

Principal Investigator:	Ricardo Kobayashi	IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ricardo Kobayashi, Researcher and Collaborator of Pain Group, University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT01835795 History of Changes
Other Study ID Numbers:	CAAE 06251612.7.0000.0068
First Posted:	April 19, 2013
Last Update Posted:	April 19, 2013
Last Verified:	April 2013

Keywords provided by Ricardo Kobayashi, University of Sao Paulo:

Myofascial Pain Syndromes; Myofascial Trigger Point; Low Back Pain; Lumbago	Shock Waves, High-Energy; High-Energy Shock Waves; Interdisciplinary Health Team; Multidisciplinary Pain Centers

Additional relevant MeSH terms:

Syndrome; Back Pain; Low Back Pain; Somatoform Disorders; Myofascial Pain Syndromes; Fibromyalgia; Disease; Pathologic Processes; Pain	Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases