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

Low Back Pain Clinical Trial

Official title:

Prospective, Comparative, Randomized Study of the Effectiveness of Shock Wave Treatment in Myofascial Pain Syndrome in Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835795
• Other study ID #: CAAE 06251612.7.0000.0068
• Status: Completed
• Phase: N/A
• Start date: January 7, 2013
• Est. completion date: January 18, 2019

Study information

• Verified date: April 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 18, 2019
• Est. primary completion date: March 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Fibromyalgia
• Low Back Pain
• Lumbago
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 weeks after the last session of shockwave