Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-25 @ 12:55 PM
Study NCT ID:
NCT01835795
Status:
COMPLETED
Last Update Posted:
2019-04-30
First Post:
2013-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radial Extracorporeal Shock Wave Treatment (rESWT) of Myofascial Pain Syndrome in Low Back Pain
Sponsor:
University of Sao Paulo
Organization:
Study Overview
Official Title:
Prospective, Comparative, Randomized Study of the Effectiveness of Shock Wave Treatment in Myofascial Pain Syndrome in Low Back Pain
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: