Low Back Pain, Lumbago, Myofascial Pain Syndromes
Conditions
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
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.
Interventions
DEVICESwiss 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
DEVICESwiss 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
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 weeks after the last session of shockwave | The outcome will be assessed by Visual Analogue Scale (VAS) |
Countries
Brazil
Outcome results
None listed