Radial Extracorporeal Shock Wave Treatment (rESWT) of Myofascial Pain Syndrome in Low Back Pain
Primary Purpose
Myofascial Pain Syndromes, Low Back Pain, Lumbago
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Swiss DolorClast® CLASSIC applicator
Swiss DolorClast® CLASSIC placebo applicator
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndromes focused on measuring Myofascial Pain Syndromes, Myofascial Trigger Point, Low Back Pain, Lumbago, Shock Waves, High-Energy, High-Energy Shock Waves, Interdisciplinary Health Team, Multidisciplinary Pain Centers
Eligibility 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
Sites / Locations
- IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Radial Extracorporeal Shock Wave
Placebo
Arm Description
Swiss DolorClast® CLASSIC applicator
Swiss DolorClast® CLASSIC placebo applicator
Outcomes
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
The outcome will be assessed by Visual Analogue Scale (VAS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01835795
Brief Title
Radial Extracorporeal Shock Wave Treatment (rESWT) of Myofascial Pain Syndrome in Low Back Pain
Official Title
Prospective, Comparative, Randomized Study of the Effectiveness of Shock Wave Treatment in Myofascial Pain Syndrome in Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 7, 2013 (Actual)
Primary Completion Date
March 19, 2018 (Actual)
Study Completion Date
January 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndromes, Low Back Pain, Lumbago
Keywords
Myofascial Pain Syndromes, Myofascial Trigger Point, Low Back Pain, Lumbago, Shock Waves, High-Energy, High-Energy Shock Waves, Interdisciplinary Health Team, Multidisciplinary Pain Centers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radial Extracorporeal Shock Wave
Arm Type
Active Comparator
Arm Description
Swiss DolorClast® CLASSIC applicator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Swiss DolorClast® CLASSIC placebo applicator
Intervention Type
Device
Intervention Name(s)
Swiss DolorClast® CLASSIC applicator
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Swiss DolorClast® CLASSIC placebo applicator
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
The outcome will be assessed by Visual Analogue Scale (VAS)
Time Frame
12 weeks after the last session of shockwave
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Kobayashi
Organizational Affiliation
IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP
City
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil
12. IPD Sharing Statement
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Radial Extracorporeal Shock Wave Treatment (rESWT) of Myofascial Pain Syndrome in Low Back Pain
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