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

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01835795

Collaborator

(none)

Enrollment

Location

Arms

72.3

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myofascial Pain Syndromes Low Back Pain Lumbago	Device: Swiss DolorClast® CLASSIC applicator Device: Swiss DolorClast® CLASSIC placebo applicator	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

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 :

Jan 7, 2013

Actual Primary Completion Date :

Mar 19, 2018

Actual Study Completion Date :

Jan 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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 [12 weeks after the last session of shockwave]
The outcome will be assessed by Visual Analogue Scale (VAS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP	Sao Paulo		Brazil	05403-010

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