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:
University of Sao Paulo
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
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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
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:
|
Back Pain Low Back Pain Myofascial Pain Syndromes Pain Fibromyalgia Syndrome Disease Muscular Diseases |
Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pathologic Processes Rheumatic Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on February 27, 2015