Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03436459
Other study ID # PetzAladarCTH
Secondary ID
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03161210 - Evaluation of Pain Regression in Patients With Myofascial Facial Pain Using Dextrose, Local Anaesthesia and Saline. N/A
Completed NCT01418170 - Dose Response Effects of Cervical Spinal Manipulative Therapy (SMT) on Pressure Sensitivity of Myofascial Trigger Points Phase 2
Not yet recruiting NCT01174667 - Massage of the Low Back Muscles Assessed With Ultrasound Scanning Phase 1/Phase 2
Completed NCT01167036 - Effectiveness of a Massage Instrument Compared to Placebo for Upper Trapezius Muscle Pain N/A
Completed NCT03273985 - Effectiveness of Dry Needling in Shortened Triceps Surae Muscle N/A
Not yet recruiting NCT05995639 - Dry Needling Versus Ozone in Myofascial Pain Syndrome N/A
Completed NCT05776199 - Myofascial Trigger Points of the Levator Scapulae Muscle N/A
Completed NCT05225571 - The Relationship of Cervical Sagittal Parameters With Pain and Disability in Cervical Myofascial Pain Syndrome
Completed NCT06258070 - Clinical Performance of Therapeutic Use of BTX for Bruxism N/A
Completed NCT03619889 - The Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder N/A
Completed NCT02029391 - Kinesio Taping in Subjects With Myofascial Pain Syndrome: a Randomized Controlled Trial N/A
Not yet recruiting NCT03088215 - Shock-Waves to Treat Fibromyalgia Pain N/A
Completed NCT05185050 - Prevalence of Myofascial Pain Syndrome in Adolescent Idiopathic Scoliosis
Recruiting NCT03709797 - Effectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients N/A
Withdrawn NCT00795106 - Trial to Evaluate the Efficacy of Topical Capsaicin to Reduce Pain and Improve Health-related Quality of Life in Adults With Chronic Myofascial Neck Pain Phase 2
Completed NCT04628312 - Foot Plantar Pressure Changes After Plantar Dry Needling N/A
Completed NCT04640558 - Gluteus Medius Latent Trigger Point and Muscle Strength in Healthy Subjects
Recruiting NCT05627830 - Ultrasound Guided Versus Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint. N/A
Not yet recruiting NCT05882838 - The Level of Knowledge and Awareness of Myofascial Pain Syndrome in the Turkish Population
Completed NCT04260906 - Auricular Vagus Nerve Stimulation For Fibromyalgia Syndrome N/A