Radial Extracorporeal Shock Wave Treatment (rESWT) of Myofascial Pain Syndrome in Low Back Pain
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ClinicalTrials.gov Identifier: NCT01835795 |
Recruitment Status
: Unknown
Verified April 2013 by Ricardo Kobayashi, University of Sao Paulo.
Recruitment status was: Recruiting
First Posted
: April 19, 2013
Last Update Posted
: April 19, 2013
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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 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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Radial Extracorporeal Shock Wave
Radial Extracorporeal Shock Wave applicator
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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
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Placebo Comparator: Placebo
Placebo applicator
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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
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- 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)

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

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