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Dry Needling and High Intensity Laser Therapy in Treatment of Myofascial Pain Syndrome

Primary Purpose

Myofascial Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
dry needle
high intensity laser therapy
Sponsored by
Emine Dundar Ahi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Myofascial pain syndrome, high-intensity laser therapy, dry needling, exercise

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Private Medar Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

exercise

exercise+HILT

exercise+dry needling

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 20, 2021
Last Updated
January 8, 2022
Sponsor
Emine Dundar Ahi
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1. Study Identification

Unique Protocol Identification Number
NCT05078333
Brief Title
Dry Needling and High Intensity Laser Therapy in Treatment of Myofascial Pain Syndrome
Official Title
Comparison of Effectiveness of Dry Needling and High Intensity Laser Therapy in Treatment of Myofascial Pain Syndrome: A Randomized Single-blind Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emine Dundar Ahi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
Keywords
Myofascial pain syndrome, high-intensity laser therapy, dry needling, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exercise
Arm Type
No Intervention
Arm Description
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.
Arm Title
exercise+HILT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
exercise+dry needling
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
dry needle
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
high intensity laser therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual anolog scale (VAS)
Description
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.
Time Frame
10 seconds
Secondary Outcome Measure Information:
Title
neck range of motion (ROM)
Description
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.
Time Frame
3 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
emine dundar ahi, assoc prof
Organizational Affiliation
private medar hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Medar Hospital
City
Kocaeli
ZIP/Postal Code
41650
Country
Turkey

12. IPD Sharing Statement

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Dry Needling and High Intensity Laser Therapy in Treatment of Myofascial Pain Syndrome

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