Radial Extracorporeal Shock Wave Treatment (rESWT) of Myofascial Pain Syndrome in Low Back Pain
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|ClinicalTrials.gov Identifier: NCT01835795|
Recruitment Status : Completed
First Posted : April 19, 2013
Last Update Posted : April 30, 2019
|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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
|Actual Study Completion Date :||January 18, 2019|
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
- 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)
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
|IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP|
|Sao Paulo, Brazil, 05403-010|
|Principal Investigator:||Ricardo Kobayashi||IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP|