NCT05078333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 20, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

September 20, 2021

Last Update Submit

January 8, 2022

Conditions

Keywords

Myofascial pain syndromehigh-intensity laser therapydry needlingexercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • neck range of motion (ROM)

    3 minutes

Study Arms (3)

exercise

NO INTERVENTION

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.

exercise+HILT

ACTIVE COMPARATOR

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.

Device: high intensity laser therapy

exercise+dry needling

ACTIVE COMPARATOR

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.

Other: dry needle

Interventions

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.

exercise+dry needling

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.

exercise+HILT

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Medar Hospital

Kocaeli, 41650, Turkey (Türkiye)

Location

Related Publications (1)

  • Ahi ED, Sirzai H. Comparison of the effectiveness of dry needling and high-intensity laser therapy in the treatment of myofascial pain syndrome: a randomized single-blind controlled study. Lasers Med Sci. 2022 Dec 20;38(1):3. doi: 10.1007/s10103-022-03687-w.

MeSH Terms

Conditions

Myofascial Pain SyndromesMotor Activity

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesBehavior

Study Officials

  • emine dundar ahi, assoc prof

    private medar hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 2021

First Posted

October 14, 2021

Study Start

August 16, 2021

Primary Completion

December 31, 2021

Study Completion

January 1, 2022

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations