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

University of Sao Paulo

Status: Completed

Conditions: Myofascial Pain Syndromes; Lumbago; Low Back Pain

Treatments: Device: Swiss DolorClast® CLASSIC placebo applicator; Device: Swiss DolorClast® CLASSIC applicator

Study type: Interventional

Funder types: Other

Identifiers

NCT01835795

CAAE 06251612.7.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups, including a placebo group

Radial Extracorporeal Shock Wave

Active Comparator group

Description:

Swiss DolorClast® CLASSIC applicator

Treatment:

Device: Swiss DolorClast® CLASSIC applicator

Placebo

Placebo Comparator group

Description:

Swiss DolorClast® CLASSIC placebo applicator

Treatment:

Device: Swiss DolorClast® CLASSIC placebo applicator