NCT07368517

Brief Summary

Mechanical neck pain is one of the most common musculoskeletal disorders among adults. It is characterized by pain and stiffness in the cervical region, often related to poor posture, repetitive movements, or prolonged sitting. The condition can lead to functional limitations and decreased quality of life. This randomized controlled clinical trial aims to evaluate the effectiveness of dry needling therapy on pain intensity, cervical range of motion, and functional ability in patients with mechanical neck pain. Forty participants aged 25 - 65 years will be randomly assigned to two groups. Group A will receive dry needling combined with neck exercises, while Group B will receive transcutaneous electrical nerve stimulation (TENS), ultrasound, and the same neck exercise program. Both groups will undergo treatment three times per week for four weeks. Primary outcomes include changes in the Neck Disability Index (NDI), pressure pain threshold (PPT) measured by algometer, and cervical range of motion (CROM). The study will determine whether dry needling provides superior clinical improvement compared with conventional electrotherapy and exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
Last Updated

January 26, 2026

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

January 16, 2026

Last Update Submit

January 16, 2026

Conditions

Keywords

Mechanical Neck PainDry NeedlingMyofascial Trigger PointsCervical SpineCervical Range of MotionPhysical Therapy

Outcome Measures

Primary Outcomes (3)

  • Change in Neck Disability Index (NDI)

    The Neck Disability Index (NDI) is a 10-item self-reported questionnaire used to assess how mechanical neck pain affects daily activities. Each item is scored from 0 to 5, and total scores are converted to a percentage, with higher values indicating greater disability. It is a valid and reliable tool for monitoring functional improvement after physiotherapy interventions.

    Baseline and after 4 weeks of treatment

  • Change in Pressure Pain Threshold (PPT)

    Pressure Pain Threshold (PPT) will be measured using a digital algometer. It represents the minimum pressure that elicits pain and provides an objective assessment of muscle tenderness and trigger point sensitivity. Higher values indicate reduced pain sensitivity. Measurements will be taken over the upper trapezius muscle in kg/cm².

    Baseline and after 4 weeks of treatment

  • Change in Cervical Range of Motion (CROM)

    Cervical Range of Motion (CROM) will be assessed using a CROM device that quantifies cervical flexion, extension, lateral flexion, and rotation. Measurements will be taken in degrees. The device provides objective and reproducible data on cervical spine mobility and is used to evaluate the effect of treatment on movement limitations.

    Baseline and after 4 weeks of treatment

Study Arms (2)

Dry Needling with Exercise

EXPERIMENTAL

Participants in this group will receive dry needling to the upper trapezius and deltoid muscles under aseptic conditions. Needles will be inserted 5-10 mm deep and held for approximately 30 seconds, then discarded. This intervention will be combined with a neck exercise program including chin-in exercises (3 sets × 10 repetitions, 5-second holds) and a muscle energy technique (3 repetitions per side, holding 5-10 seconds). Sessions: three per week for four weeks.

Other: Dry Needling with Exercise

Conventional Physiotherapy with Exercise

ACTIVE COMPARATOR

Participants in this group will receive conventional physiotherapy including transcutaneous electrical nerve stimulation (TENS) at 80-100 Hz, 100 µs pulse duration for 20 minutes, and pulsed ultrasound at 1 MHz, 1.0-1.5 W/cm² for 5 minutes. The same exercise program will be applied (chin-in and muscle-energy technique). Sessions: three per week for four weeks.

Other: Conventional Physiotherapy with Exercise

Interventions

Manual therapy procedure using sterile, single-use needles inserted into the upper trapezius and deltoid muscles for approximately 30 seconds to reduce trigger point activity. Combined with neck exercises (chin-in and muscle-energy technique). Administered three times per week for four weeks.

Dry Needling with Exercise

Standard physiotherapy treatment consisting of TENS (80-100 Hz, 100 µs, 20 min) and ultrasound (1 MHz, 1.0-1.5 W/cm², 5 min) combined with neck exercises (chin-in and muscle-energy technique). Administered three times per week for four weeks.

Conventional Physiotherapy with Exercise

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medically stable individuals who provide written informed consent to participate in the study.
  • Age between 25 and 65 years.
  • Both male and female participants.
  • Patients diagnosed with mechanical neck pain lasting more than three months.
  • Presence of myofascial trigger points in the upper trapezius or cervical muscles confirmed by palpation.
  • Ability to follow treatment instructions and attend all scheduled sessions.

You may not qualify if:

  • History of neck surgery or cervical spine fracture.
  • Previous dry needling or invasive therapy for neck pain in the past six months.
  • History of neurological disorders (e.g., cervical radiculopathy, myelopathy).
  • Current acute infection, skin disease, or open wound in the neck or shoulder region.
  • Use of anticoagulant medication or any bleeding disorder.
  • Pregnancy or suspected pregnancy.
  • Any systemic illness (e.g., diabetes mellitus, rheumatoid arthritis) that may affect healing or pain perception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy, Deraya University

Minya, Menia Governorate, Egypt

Location

Related Publications (11)

  • Ebadi, S., Ansari, N. N., Naghdi, S., & Jalaie, S. (2018). The effect of therapeutic ultrasound on neck pain: A systematic review. Ultrasound in Medicine & Biology, 44(3), 566-576. https://doi.org/10.1016/j.ultrasmedbio.2017.11.014

    BACKGROUND
  • Audette, I., Dumas, J. P., Côté, J. N., & De Serres, S. J. (2019). Validity and between-day reliability of cervical range of motion measurements. Journal of Orthopaedic & Sports Physical Therapy, 49(7), 510-517. https://doi.org/10.2519/jospt.2019.8583

    BACKGROUND
  • Tousignant-Laflamme, Y., Boutin, A., Dion, A. M., & Vallée, C. A. (2017). Reliability and criterion validity of two applications of the cervical range of motion device. Physiotherapy Theory and Practice, 33(2), 140-150. https://doi.org/10.1080/09593985.2016.1271845

    BACKGROUND
  • Vaegter HB, Handberg G, Graven-Nielsen T. Similarities between exercise-induced hypoalgesia and conditioned pain modulation in humans. Pain. 2014 Jan;155(1):158-167. doi: 10.1016/j.pain.2013.09.023. Epub 2013 Sep 26.

    PMID: 24076045BACKGROUND
  • Walton DM, Macdermid JC, Nielson W, Teasell RW, Chiasson M, Brown L. Reliability, standard error, and minimum detectable change of clinical pressure pain threshold testing in people with and without acute neck pain. J Orthop Sports Phys Ther. 2011 Sep;41(9):644-50. doi: 10.2519/jospt.2011.3666. Epub 2011 Sep 1.

    PMID: 21885906BACKGROUND
  • Vernon H. The Neck Disability Index: state-of-the-art, 1991-2008. J Manipulative Physiol Ther. 2008 Sep;31(7):491-502. doi: 10.1016/j.jmpt.2008.08.006.

    PMID: 18803999BACKGROUND
  • Navarro-Santana MJ, Sanchez-Infante J, Fernandez-de-Las-Penas C, Cleland JA, Martin-Casas P, Plaza-Manzano G. Effectiveness of Dry Needling for Myofascial Trigger Points Associated with Neck Pain Symptoms: An Updated Systematic Review and Meta-Analysis. J Clin Med. 2020 Oct 14;9(10):3300. doi: 10.3390/jcm9103300.

    PMID: 33066556BACKGROUND
  • Liu L, Huang QM, Liu QG, Ye G, Bo CZ, Chen MJ, Li P. Effectiveness of dry needling for myofascial trigger points associated with neck and shoulder pain: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2015 May;96(5):944-55. doi: 10.1016/j.apmr.2014.12.015. Epub 2015 Jan 7.

    PMID: 25576642BACKGROUND
  • Gross AR, Paquin JP, Dupont G, Blanchette S, Lalonde P, Cristie T, Graham N, Kay TM, Burnie SJ, Gelley G, Goldsmith CH, Forget M, Santaguida PL, Yee AJ, Radisic GG, Hoving JL, Bronfort G; Cervical Overview Group. Exercises for mechanical neck disorders: A Cochrane review update. Man Ther. 2016 Aug;24:25-45. doi: 10.1016/j.math.2016.04.005. Epub 2016 Apr 20.

    PMID: 27317503BACKGROUND
  • Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.

    PMID: 28666405BACKGROUND
  • Cote P, Wong JJ, Sutton D, Shearer HM, Mior S, Randhawa K, Ameis A, Carroll LJ, Nordin M, Yu H, Lindsay GM, Southerst D, Varatharajan S, Jacobs C, Stupar M, Taylor-Vaisey A, van der Velde G, Gross DP, Brison RJ, Paulden M, Ammendolia C, David Cassidy J, Loisel P, Marshall S, Bohay RN, Stapleton J, Lacerte M, Krahn M, Salhany R. Management of neck pain and associated disorders: A clinical practice guideline from the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Eur Spine J. 2016 Jul;25(7):2000-22. doi: 10.1007/s00586-016-4467-7. Epub 2016 Mar 16.

    PMID: 26984876BACKGROUND

MeSH Terms

Conditions

Neck PainMusculoskeletal Diseases

Interventions

Dry NeedlingExercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study. Both participants and care providers are aware of the assigned interventions due to the physical nature of the treatments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned into two parallel groups. Group A will receive dry needling with neck exercises, and Group B will receive TENS, ultrasound, and neck exercises. Both groups will receive treatment three times per week for four weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 26, 2026

Study Start

October 5, 2025

Primary Completion

December 1, 2025

Study Completion

December 15, 2025

Last Updated

January 26, 2026

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations