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

Not Applicable

Completed

• Conditions: Myofascial Pain Syndrome
• Interventions: Device: Extracorporeal Shock Wave Therapy; Device: Low Level Laser Therapy

• Registration Number: NCT03436459
• Lead Sponsor: Petz Aladar County Teaching Hospital

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.

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2017-02
• Study Completion: 2017-09
• Status Verified: 2018-02
• Study First Submitted: 2018-02-11
• Study First Submitted QC: 2018-02-11
• Last Update Submitted: 2018-02-17
• Study First Posted: 2018-02-19
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extracorporeal shock wave therapy group	Extracorporeal Shock Wave Therapy	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.
Low Level Laser Therapy group	Low Level Laser Therapy	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.

Primary Outcome Measures

Name	Time	Method
change in severity of pressure pain	week 0 and week 15	change from baseline severity of pressure pain recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
change in function (percentage of disability)	week 0 and week 15	change from baseline Neck Disability Index (NDI) at week 15. It includes 10 part; pain intensity, personal care, lifting objects, reading, headache, concentration, work, driving, sleeping and entertainments. There are six presumptions; the first is given 0 and the last presumption has the score of 5. The total maximum score is 50, that represents 100% disability. The lower score represents better outcome.
change in severity of pain at rest	week 0 and week 15	change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
change in quality of life	week 0 and week 15	change from baseline quality of life (SF-36) at week 15. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more the disability, i.e. a score of zero is equivalent to maximum disability.

Trial Locations

Locations (1)

Petz Aladár County Teaching Hospital; 🇭🇺 Győr, Hungary