NCT07637552

Brief Summary

The purpose of this clinical trial is to compare the effects of deep versus superficial dry needling (DN) on the ultrasound and electromyographic (EMG) characteristics of myofascial trigger points (MTrPs) in the upper trapezius muscle of patients with neck pain. Researchers aim to determine which dry needling technique produces greater improvements in muscle properties (ultrasound and EMG findings), pain intensity, and functional disability. Intervention: Participants will be randomly assigned to receive either deep DN or superficial DN. Each participant will undergo four treatment sessions over a two-week period. Assessments: Outcomes will be measured at three time points:

  • Baseline (before treatment)
  • Post-treatment (end of week 2)
  • Follow-up (4 weeks after treatment)

Trial Health

75
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress70%
Oct 2025Oct 2026

First Submitted

Initial submission to the registry

September 17, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

September 17, 2025

Last Update Submit

June 4, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Upper Trapezius Muscle Thickness by B-mode Sonography

    B-mode sonography will be used to measure the thickness at rest of the upper trapezius muscle by calculating the greatest distance between the lower and upper boundaries of the muscle, expressed in millimeters. The ultrasonic probe was positioned in alignment with the muscle fibers of the upper trapezius muscle. The MTrP should appear as a concentrated area with reduced echogenicity (darker) and an uneven echotexture (Taheri et al., 2016; Adigozali et al., 2017). B-mode sonography is highly reliable in assessing muscle thickness (ICC = 0.98) (Adigozali et al., 2016).

    Baseline, Post two weeks and post 4 weeks

  • Upper Trapezius Muscle Stiffness by Strain Elastography

    Strain elastography will be used to measure tissue stiffness. Images will be obtained with the linear transducer positioned longitudinally along the muscle fibers, while applying gentle, rhythmic compression to ensure adequate tissue deformation. Care will be taken to maintain consistent pressure and probe alignment throughout the examination. Regions of interest (ROIs) will be selected within the upper trapezius muscle with a size of 5 mm2. The reference ROI will be positioned within the subcutaneous tissue, while a second ROI will be placed in the upper trapezius muscle fiber. Strain ratio will be measured (Sawada et al., 2020). In this imaging setup, softer tissues is displayed in red, whereas stiffer tissues is represented in blue. Strain elastography has demonstrated moderate to good reliability (ICC = 0.70-0.81) (Salavati et al., 2017)

    Baseline, Post two weeks and post 4 weeks

  • Blood Flow by Doppler ultrasonography

    Doppler ultrasonography will be used to visualize blood vessels and measure the speed of blood flow at both active MTrPs and muscle throughout both the systolic and diastolic periods. The sonographer will use the ultrasound transducer to apply two distinct levels of pressure to the muscle fibers of the upper trapezius muscle. The first level involves minimum pressure, with the transducer barely making contact with the skin surface. The second level provides moderate pressure and visible squeezing of the muscle. The peak systolic velocity (PSV; cm/s), end diastolic velocity (EDV; cm/s), and resistance index (RI) (Adigozali et al., 2017) will be calculated. The reliability of doppler ultrasonography in measuring blood flow is moderate to excellent (ICC = 0.67-0.87) (Adigozali et al., 2017; Sikdar et al., 2010).

    Baseline, Post two weeks and post 4 weeks

  • Upper Trapezius Muscle Activity and Fatigability by Surface Electromyography

    In this study, muscle activity of the affected upper trapezius was assessed using a Delsys Trigno™ wireless surface electromyography (sEMG) system (Delsys Inc., Natick, MA, USA). All measurements were performed by a well-trained physiotherapist. Skin preparation and sensor placement followed the Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM recommendations, adapted for wireless integrated EMG sensors (Hermens et al., 2000). A single Trigno sensor was positioned over the upper trapezius muscle at approximately 50% of the distance between the spinous process of the seventh cervical vertebra (C7) and the acromion. The sensor was oriented with its long axis aligned parallel to the direction of the muscle fibers. Prior to sensor fixation using adhesive tape, the skin was prepared by shaving (if necessary), light abrasion, and cleaning with an alcohol swab to reduce skin impedance. EMG signals were sampled at a frequency of 1,000 Hz with a band width of 20-450

    Baseline, Post two weeks and post 4 weeks

Secondary Outcomes (2)

  • Pain Intensity

    Baseline, post two weeks and post 4 weeks

  • Neck Disability

    Baseline, post two weeks and post 4 weeks

Study Arms (2)

Group 1: Deep Dry Needling

EXPERIMENTAL

22 Participants randomly assigned to this group will receive deep dry needling targeting the myofascial trigger points (MTrPs) of the upper trapezius muscle. The procedure will be performed by a licensed physiotherapist at Qatif Central Hospital. The needle will be inserted into the muscle to reach the MTrP and provoke a local twitch response.

Other: Deep Dry Needling and Superficial Dry Needling

Group 2: Superficial Dry Needling

ACTIVE COMPARATOR

22 Participants randomly assigned to this group will receive superficial dry needling applied to the skin area overlying the identified MTrPs of the upper trapezius muscle. The same physiotherapist will perform all procedures in the same clinical setting. The needle will be inserted minimally without penetrating the muscle or eliciting a local twitch response.

Other: Deep Dry Needling and Superficial Dry Needling

Interventions

* Deep Dry needling is performed by a trained physiotherapist using a sterile solid filiform needle inserted deeply into the muscle tissue to directly reach the myofascial trigger point (MTrP) within the upper trapezius. The needle is advanced until a local twitch response is elicited, aiming to disrupt dysfunctional motor endplate activity, improve local circulation, and reduce pain and muscle tension. Participants will receive four treatment sessions over two weeks. * Superficial dry needling is performed by a trained physiotherapist using a sterile solid filiform needle inserted superficially into the skin overlying the identified MTrP in the upper trapezius, without penetrating the muscle or eliciting a local twitch response. The technique aims to modulate pain through stimulation of cutaneous Aδ fibers and spinal inhibitory pathways. Participants will receive four treatment sessions over two weeks.

Group 1: Deep Dry NeedlingGroup 2: Superficial Dry Needling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with neck pain
  • Has least one active myofascial trigger point in the upper trapezius muscle

You may not qualify if:

  • whiplash injury
  • Prior cervical surgery
  • Cervical radiculopathy
  • Fibromyalgia
  • Using analgesic treatment (e.g., physiotherapy or medication) within the week preceding participation
  • Psychiatric disorders
  • Any contraindication to dry needling (e.g., needle phobia and/or anticoagulant use).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qatif Central Hospital

Dammam, Eastern Province, 32654, Saudi Arabia

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ali M Alshami, PhD

    Professor, Imam Abdulrahman Bin Faisal University

    STUDY DIRECTOR

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
Senior Musculoskeletal Rehabilitation Specialist

Study Record Dates

First Submitted

September 17, 2025

First Posted

June 9, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations