NCT06546124

Brief Summary

The aim of this study is to compare the effects of superficial and deep dry needling techniques, guided by ultrasound, on pain, disability, functional impairment, and quality of life in patients diagnosed with myofascial pain syndrome of the upper trapezius muscle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

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

First Submitted

Initial submission to the registry

August 7, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

August 11, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

January 27, 2026

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

August 7, 2024

Last Update Submit

January 26, 2026

Conditions

Outcome Measures

Primary Outcomes (10)

  • The Numerical Pain Rating Scale

    It is used to measure pain. The numerical scale for perceived pain intensity usually includes 11 numbers. The participant selects the number that best reflects their pain. In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.

    Before treatment

  • The Numerical Pain Rating Scale

    It is used to measure pain. The numerical scale for perceived pain intensity usually includes 11 numbers. The participant selects the number that best reflects their pain. In our study, participants were informed that '0' indicates no pain and '10' represents pain of unbearable intensity.

    1 week after treatment

  • Pressure Pain Threshold

    A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception. It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity. The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf). In our study, a manual algometer (Baseline® Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used. The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation. The average of these three measurements will be included in the evaluation.

    Before treatment

  • Pressure Pain Threshold

    A pressure algometer (dolorimeter) is a device used for assessing pain sensitivity and measuring pressure perception. It has been proven useful in evaluating trigger points, arthritis activation, and visceral pain-pressure sensitivity. The pressure algometer consists of a metal piston with a rubber disc at the end, which has a 1 cm² surface, and is connected to a gauge that measures pressure in kilograms of force (kgf). In our study, a manual algometer (Baseline® Dolorimeter, Fabrication Enterprises, Inc, NY, USA) was used. The algometric measurement will be performed three times on the most painful point as reported by the patient and detected by palpation. The average of these three measurements will be included in the evaluation.

    1 week after treatment

  • Neck disability index

    The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability. This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities. The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities. Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter. Each item is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (total disability). After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment. As the score increases, disability increases; as the score decreases, disability decreases.

    Before treatment

  • Neck disability index

    The Neck Disability Index (NDI) Turkish version was used for assessing patients' disability. This index is a scale consisting of 10 questions used to evaluate how and to what extent neck pain affects the patient's daily living activities. The scale includes parameters such as pain intensity, self-care, lifting, reading, headache, concentration, driving, sleep, and social activities. Patients were asked to mark the option that best applies to them from the 6 choices provided for each parameter. Each item is scored from 0 (no disability) to 5 (complete disability). The total score ranges from 0 (no disability) to 50 (total disability). After obtaining the total score, the value calculated according to the formula is expressed as a percentage of impairment. As the score increases, disability increases; as the score decreases, disability decreases.

    1 week after treatment

  • Neck bournemouth questionnaire

    Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain. The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies. Each of the 7 questions is scored from 0 to 10. The highest possible score is 70, with a higher score indicating a higher level of disability.

    Before treatment

  • Neck bournemouth questionnaire

    Adapted from the Bournemouth Low Back Pain Questionnaire developed by Bolton and Humphreys in 2002, this questionnaire includes variables that must be assessed in individuals with neck pain. The content of the questionnaire covers pain intensity, the impact of pain on daily living activities and social life, anxiety and depression levels, kinesiophobia, and pain coping strategies. Each of the 7 questions is scored from 0 to 10. The highest possible score is 70, with a higher score indicating a higher level of disability.

    1 week after treatment

  • Joint range of Motion Measurement

    Joint range of motion is measured using a goniometric protractor with the Neutral-0 Method. While the person sits upright in a chair, the goniometer is used to measure the range of motion of the neck in the directions of flexion, extension, lateral flexion, and rotation.

    Before treatment

  • Joint range of Motion Measurement

    Joint range of motion is measured using a goniometric protractor with the Neutral-0 Method. While the person sits upright in a chair, the goniometer is used to measure the range of motion of the neck in the directions of flexion, extension, lateral flexion, and rotation.

    1 week after treatment

Secondary Outcomes (2)

  • Advers event

    1 week after treatment

  • Cutaneous and subcutaneous thickness

    Before treatment

Study Arms (2)

Deep fascia dry needling technique

ACTIVE COMPARATOR

Deep fascia dry needling technique

Other: Deep Fascia Dry needling Technique

İntramuscular trigger point dry needling technique

ACTIVE COMPARATOR

İntramuscular trigger point dry needling technique

Other: Intramuscular Trigger Point Dry Needling Technique

Interventions

"Participants will undergo a single session of dry needling on the painful area of the upper trapezius muscle on the right and/or left side of the neck, either unilaterally or bilaterally. All participants will be positioned upright in a chair with their backs supported, heads in a neutral position, and arms at their sides. A myofascial trigger point on the upper trapezius muscle will be marked. A sterile acupuncture needle, 0.25 mm in diameter and 40 mm in length, will be used. Under ultrasound guidance, the needle will be inserted at three points, including 1 cm lateral and medial to the marked point, penetrating subcutaneously to the deep fascia. After leaving the needle in place for 5 minutes, it will be rotated clockwise and left in place for an additional 5 minutes. The needles will be removed after a total of 10 minutes. Participants will be advised to perform upper trapezius stretching exercises."

Deep fascia dry needling technique

"Participants will undergo a single session of dry needling on the painful area of the upper trapezius muscle on the right and/or left side of the neck, either unilaterally or bilaterally. All participants will be positioned upright in a chair with their backs supported, heads in a neutral position, and arms at their sides. A myofascial trigger point on the upper trapezius muscle will be marked. A sterile acupuncture needle, 0.25 mm in diameter and 40 mm in length, will be used. Under ultrasound guidance, the needle will be inserted at three points, including 1 cm lateral and medial to the marked point, penetrating through the deep fascia into the upper trapezius muscle. After leaving the needle in place for 5 minutes, it will be rotated clockwise and left in place for an additional 5 minutes. The needles will be removed after a total of 10 minutes. Participants will be advised to perform upper trapezius stretching exercises."

İntramuscular trigger point dry needling technique

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of MPS in the upper trapezius muscle in accordance with criteria defined by Travell and Simons
  • Ages between 20 and 50 years
  • No treatment, including injections, dry needling, and physical methods, applied to the cervical region in the last three months

You may not qualify if:

  • Bleeding Tendency
  • History of Neck and Shoulder Trauma
  • Other Conditions Affecting Neck and Shoulder Pain: including malignancy, infection, rheumatic diseases, degenerative joint disease, fibromyalgia, cervical radiculopathy, neuropathy, myelopathy, myopathy, adhesive capsulitis, etc.
  • Cases Where Evaluation Could Not Be Completed for Any Reason
  • Patients Who Refuse to Complete the Evaluations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant Izzet Baysal University

Bolu, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

August 7, 2024

First Posted

August 9, 2024

Study Start

August 11, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

January 27, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations