- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05078333
Dry Needling and High Intensity Laser Therapy in Treatment of Myofascial Pain Syndrome
Comparison of Effectiveness of Dry Needling and High Intensity Laser Therapy in Treatment of Myofascial Pain Syndrome: A Randomized Single-blind Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kocaeli, Turkey, 41650
- Private Medar Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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NO_INTERVENTION: exercise
All patients in all three groups will perform 15 sessions (for 3 weeks, weekdays), cervical area isometric strengthening exercises, active ROM exercises and stretching exercises for 15 minutes a day with the same physiotherapist.
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ACTIVE_COMPARATOR: exercise+HILT
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.
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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.
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ACTIVE_COMPARATOR: exercise+dry needling
In addition to the exercise program, dry needling (on 3 trigger points on the bilateral trapezius muscle) will be 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual anolog scale (VAS)
Time Frame: 10 seconds
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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.
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10 seconds
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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neck range of motion (ROM)
Time Frame: 3 minutes
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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.
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3 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: emine dundar ahi, assoc prof, Private Medar Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K-064
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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