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

Myofascial Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436459
• Other study ID #: PetzAladarCTH
• Status: Completed
• Phase: N/A
• First received: February 11, 2018
• Last updated: February 17, 2018
• Start date: February 2016
• Est. completion date: September 2017

Study information

• Verified date: February 2018
• Source: Petz Aladar County Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
Hungary	Petz Aladár County Teaching Hospital	Gyor

Sponsors (1)

Lead Sponsor	Collaborator
Petz Aladar County Teaching Hospital

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in severity of pain at rest	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.	week 0 and week
Primary	change in severity of pain at rest	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.	week 0 and week 15
Primary	change in severity of pressure pain	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.	week 0 and week 3
Primary	change in severity of pressure pain	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.	week 0 and week 15
Primary	change in function (percentage of disability)	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.	week 0 and week 3
Primary	change in function (percentage of disability)	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.	week 0 and week 15
Primary	change in quality of life	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.	week 0 and week 3
Primary	change in quality of life	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.	week 0 and week 15