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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Ricardo Kobayashi, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01835795
First received: April 14, 2013
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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 Intervention
Myofascial Pain Syndromes
Myofascial Trigger Point
Low Back Pain
Lumbago
Device: Radial Extracorporeal Shock Wave
Device: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    The outcome will be assessed by Visual Analogue Scale (VAS)


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835795

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

No publications provided

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
Study First Received: April 14, 2013
Last Updated: April 18, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by 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:
Low Back Pain
Back Pain
Myofascial Pain Syndromes
Fibromyalgia
Shock
Somatoform Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Pathologic Processes
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014