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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05078333
Other study ID # K-064
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 16, 2021
Est. completion date January 1, 2022

Study information

Verified date January 2022
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

108 myofascial pain syndrome (MPS) diagnosed patients will be randomly divided into 3 groups. To groups; exercise, exercise+high-intensity laser therapy (HILT) and exercise+dry needling will be applied. Visual anolog scale (VAS) scores and neck range of motion (ROM) of the patients before-after treatment will be recorded and will be evaluated statistically.


Description:

Myofascial pain syndrome (MPS) is a very common disease in the population that seriously affects the quality of life. Although many modalities are used in its treatment, there is still no common protocol. In this study, the investigators aim to compare the effectiveness of high-intensity laser therapy (HILT), which has been popular in recent years, with exercise and dry needling options that have been used for years. In our study 108 myofascial pain syndrome (MPS) diagnosed patients will be randomly divided into 3 groups. To groups; exercise, exercise+high-intensity laser therapy (HILT) and exercise+dry needling will be applied. Visual anolog scale (VAS) scores and neck range of motion (ROM) of the patients before-after treatment will be recorded and will be evaluated statistically.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date January 1, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - diagnosed with neck and / or back pain - diagnosed with MPS - had a taut band on the trapezius muscle and at least one active trigger point Exclusion Criteria: - Diagnosed with fibromyalgia, - had systemic disease, - significant cervical disc lesion / radiculopathy / myelopathy, - had trigger point injection in the last 6 months, - had neck or shoulder surgery in the year before being included in the study, - was pregnant, - received anticoagulant therapy, - used aspirin in the last three days, and - with the cognitive dysfunction patients

Study Design


Intervention

Other:
dry needle
dry needling (on 3 trigger points on the bilateral trapezius muscle) will applied to the other 36 randomly selected patients with an acupuncture needle with a size of 0.25x0.25 by the PMR specialist for a total of 6 sessions twice a week for 3 weeks.
Device:
high intensity laser therapy
High intensity laser therapy (HILT), one of the physical therapy methods, was approved by the FDA in 2002. Its beneficial and versatile effect has been proven in the treatment of many musculoskeletal diseases. In addition to the exercise program, randomly selected 36 case patients + HILT (BTL brand 6000 series, United Kingdom), to the cervical area, for the a period of 3 week-weekdays, 15-minute period and 15 sessions (1.02 minutes for each 25 cm² painful area, analgesic phase, with an anergy 8.0 W, a dose 5 J / cm², a frequency of 25 Hz and total 125 joules) will be applied.

Locations

Country Name City State
Turkey Private Medar Hospital Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Emine Dundar Ahi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual anolog scale (VAS) A Visual Analogue Scale (VAS) is a horizontal line, 100 mm in length measurement instrument that tries to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. 10 seconds
Secondary neck range of motion (ROM) Range of motion (ROM) of the cervical vertebra (flexion, extansion, right-left lateral flexion, right-left rotation) will be measured with goniometre 3 times by a physiotherapist, who does not know the content of the study and mean values will be recorded. 3 minutes
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