Clinical trial NCT03436459: Effects of Extracorporeal Shock Wave Therapy and Low Level Laser Therapy in Myofascial Pain Syndrome
Official title: Comparative Study of Shock Wave Therapy and Low Level Laser Therapy Effect in Patients With Myofascial Pain Syndrome of the Trapezius
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Keywords: extracorporeal shock wave therapy (ESWT)
Low level laser therapy (LLLT)
Myofascial Pain Syndrome
Lead sponsor: Petz Aladar County Teaching Hospital
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of low level laser therapy and extracorporeal shock wave therapy in patients with myofascial pain syndrome of the upper trapezius. Half of the patients receive laser therapy, half of them receive shock wave therapy for three weeks.

Detailed description: Low Level Laser Therapy (LLLT) inducing photochemical and photothermal effect, increases blood flow and vascular permeability and improves cell metabolism. All these lead to muscle recovery. It also activates somatosensory receptors of the skin and reduces local pain and muscle spasm.

The specific mechanisms of extracorporeal shock wave therapy (ESWT) in treating musculoskeletal pain remain unclear. It reduces pain and inflammation by modulating nitrogen-monoxide (NO) and vascular endothelial growth factor (VEGF). It can destroy sensory unmyelinated nerve fibers, and stimulate neovascularization and collagen synthesis in degenerative tissues.

Eligibility criteria: Inclusion Criteria:

* patients over 18 years of age with myofascial pain syndrome meeting the Simon's diagnostic criteria (5 major and 1 minor) for at least 8 weeks (chronic pain)
* no physiotherapy or local injection within 3 months before starting the study

Exclusion Criteria:

* acute onset of neck pain
* physiotherapy or local injection within 3 months before starting the study
* abnormal lab test (ESR, hematology)
* infection, fever
* cervical radiculopathy
* uncontrolled hypertension, anticoagulation or defect in blood coagulation
* previous cervical operaton

Primary outcomes:
measure: change in severity of pain at rest
timeFrame: week 0 and week
measure: change in severity of pain at rest
timeFrame: week 0 and week 15
measure: change in severity of pressure pain
timeFrame: week 0 and week 3
measure: change in severity of pressure pain
timeFrame: week 0 and week 15
measure: change in function (percentage of disability)
timeFrame: week 0 and week 3
measure: change in function (percentage of disability)
timeFrame: week 0 and week 15
measure: change in quality of life
timeFrame: week 0 and week 3
measure: change in quality of life
timeFrame: week 0 and week 15
Secondary outcomes:
Other outcomes:
Locations:
city: Győr
country: Hungary
facility: Petz Aladár County Teaching Hospital
Study officials:
References:
citation: Kiraly M, Bender T, Hodosi K. Comparative study of shockwave therapy and low-level laser therapy effects in patients with myofascial pain syndrome of the trapezius. Rheumatol Int. 2018 Nov;38(11):2045-2052. doi: 10.1007/s00296-018-4134-x. Epub 2018 Aug 31.