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
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.
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.
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