Effects of Extracorporeal Shock Wave Therapy and Low Level Laser Therapy in Myofascial Pain Syndrome

NCT ID: NCT03436459

Last Updated: 2018-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Myofascial Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Extracorporeal shock wave therapy group

Patients in the shock wave therapy group received total of 1000 shock waves for each treatment at the frequency of 10Hz, with 2 Bar pressure and energy flux density (EFD) of 0.25 mJ/mm2 per minute by using BTL-6000 SWT Topline Power® 3 times with a week's interval between the treatments.

Group Type ACTIVE_COMPARATOR

Extracorporeal Shock Wave Therapy

Intervention Type DEVICE

shock wave therapy once a week for three weeks, total of 1000 shock waves for each treatment at the frequency of 10Hz, with 2 Bar pressure and energy flux density (EFD) of 0.25 mJ/mm2 per minute using a BTL-6000 SWT Topline Power® device

Low Level Laser Therapy group

Patients in the laser therapy group received LLLT once a day for three weeks (altogether 15 working days) to the trigger points and around them in the upper trapezius. The type of laser used: PR999 4 Watt (W) scanning laser; Medical Italia®, around trigger points with 3 Joule /centimeter² (J/cm²), power 800 milliwatt (mW), frequency 2000 Hertz (Hz), on trigger points with 9 J/cm², power 2000mW, frequency 5000Hz for total of 2 minutes on each spot.

Group Type ACTIVE_COMPARATOR

Low Level Laser Therapy

Intervention Type DEVICE

LLLT once a day for three weeks (altogether 15 working days) using a PR999 4W scanning laser device; around trigger points with 3 J/cm2, power 800 mW, frequency 2000Hz, on trigger points with 9 J/cm², power 2000mW, frequency 5000Hz for total of 2 minutes on each spot

Interventions

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Extracorporeal Shock Wave Therapy

shock wave therapy once a week for three weeks, total of 1000 shock waves for each treatment at the frequency of 10Hz, with 2 Bar pressure and energy flux density (EFD) of 0.25 mJ/mm2 per minute using a BTL-6000 SWT Topline Power® device

Intervention Type DEVICE

Low Level Laser Therapy

LLLT once a day for three weeks (altogether 15 working days) using a PR999 4W scanning laser device; around trigger points with 3 J/cm2, power 800 mW, frequency 2000Hz, on trigger points with 9 J/cm², power 2000mW, frequency 5000Hz for total of 2 minutes on each spot

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Petz Aladar County Teaching Hospital

OTHER

Sponsor Role lead

Responsible Party

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Márta Király

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Petz Aladár County Teaching Hospital

Győr, , Hungary

Site Status

Countries

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Hungary

References

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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.

Reference Type DERIVED
PMID: 30171341 (View on PubMed)

Other Identifiers

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PetzAladarCTH

Identifier Type: -

Identifier Source: org_study_id

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