Clinical trial NCT01835795: Radial Extracorporeal Shock Wave Treatment (rESWT) of Myofascial Pain Syndrome in Low Back Pain
Official title: Prospective, Comparative, Randomized Study of the Effectiveness of Shock Wave Treatment in Myofascial Pain Syndrome in Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndromes
Low Back Pain
Lumbago
Keywords: Myofascial Pain Syndromes
Myofascial Trigger Point
Low Back Pain
Lumbago
Shock Waves, High-Energy
High-Energy Shock Waves
Interdisciplinary Health Team
Multidisciplinary Pain Centers
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: 12 weeks after the last session of shockwave
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP
Study officials:
affiliation: IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP
name: Ricardo Kobayashi
role: PRINCIPAL_INVESTIGATOR
References: