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

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ClinicalTrials.gov Identifier: NCT01835795
Recruitment Status : Active, not recruiting
First Posted : April 19, 2013
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ricardo Kobayashi, University of Sao Paulo

Study Description
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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 Low Back Pain Lumbago Device: Swiss DolorClast® CLASSIC applicator Device: Swiss DolorClast® CLASSIC placebo applicator Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Comparative, Randomized Study of the Effectiveness of Shock Wave Treatment in Myofascial Pain Syndrome in Low Back Pain
Actual Study Start Date : January 7, 2013
Actual Primary Completion Date : March 19, 2018
Estimated Study Completion Date : December 14, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Radial Extracorporeal Shock Wave
Swiss DolorClast® CLASSIC applicator
 Device: Swiss DolorClast® CLASSIC applicator
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
Placebo Comparator: Placebo
Swiss DolorClast® CLASSIC placebo applicator
 Device: Swiss DolorClast® CLASSIC placebo applicator
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


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: 12 weeks after the last session of shockwave ]
    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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835795


Locations
Brazil
IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP
Sao Paulo, Brazil, 05403-010
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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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    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018

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