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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radial Extracorporeal Shock Wave | Active Comparator | Swiss DolorClast® CLASSIC applicator |
|
| Placebo | Placebo Comparator | Swiss DolorClast® CLASSIC placebo applicator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swiss DolorClast® CLASSIC applicator | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo Kobayashi | IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IOT HCFMUSP - Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da USP | São Paulo | 05403-010 | Brazil |
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| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D001416 | Back Pain |
| D010146 | Pain |
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| Swiss DolorClast® CLASSIC placebo applicator | Device | 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 |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |