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Completed

NCT Number: NCT03436459

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

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.

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Key information

Conditions

Myofascial Pain Syndrome Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Petz Aladár County Teaching Hospital

Győr, 9025, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extracorporeal Shock Wave Therapy

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

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

Primary outcomes

  1. change in severity of pain at rest

    Time frame: week 0 and week

    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.

  2. change in severity of pain at rest

    Time frame: 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.

  3. change in severity of pressure pain

    Time frame: week 0 and week 3

    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.

  4. change in severity of pressure pain

    Time frame: 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.

  5. change in function (percentage of disability)

    Time frame: week 0 and week 3

    change from baseline Neck Disability Index (NDI) at week 3. 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.

  6. change in function (percentage of disability)

    Time frame: 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.

  7. change in quality of life

    Time frame: week 0 and week 3

    change from baseline quality of life (36-Item Short Form Health Survey /SF-36/) at week 3. 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.

  8. change in quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Petz Aladar County Teaching Hospital

Other

Registry information

Official study title

Comparative Study of Shock Wave Therapy and Low Level Laser Therapy Effect in Patients With Myofascial Pain Syndrome of the Trapezius

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 19, 2018
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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