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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified April 2013 by Ricardo Kobayashi, University of Sao Paulo.
Recruitment status was: Recruiting

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

History of Changes

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 Intervention Model: Crossover Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Fibromyalgia Shock

U.S. FDA Resources

Further study details as provided by Ricardo Kobayashi, 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 ]
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 (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

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


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

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

ClinicalTrials.gov processed this record on June 23, 2017

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