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

NCT ID: NCT01835795

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-07
• Study Completion Date: 2019-01-18

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.

Conditions

Myofascial Pain Syndromes; Low Back Pain; Lumbago

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Radial Extracorporeal Shock Wave

Swiss DolorClast® CLASSIC applicator

Group Type: ACTIVE_COMPARATOR

Swiss DolorClast® CLASSIC applicator

Intervention Type: DEVICE

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

Swiss DolorClast® CLASSIC placebo applicator

Group Type: PLACEBO_COMPARATOR

Swiss DolorClast® CLASSIC placebo applicator

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ricardo Kobayashi

Researcher and Collaborator of Pain Group

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ricardo Kobayashi

Role: PRINCIPAL_INVESTIGATOR

IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP

Locations

IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

CAAE 06251612.7.0000.0068

Identifier Type: -

Identifier Source: org_study_id