NCT06459804

Brief Summary

Mechanical neck pain is posteriorly occurring non-specific pain that originates from the superior nuchal line and extends to the first thoracic vertebrae. It is exacerbated by sustained neck postures, neck movements or cervical muscle palpation. The aim of study will be to compare the effects of Electro Dry Needling and Dry Needling on pain, muscle strength, disability and range of motion in patients with Levator Scapulae Syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

June 30, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

June 11, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

neck paindisabilitymuscle strengthRange of Motion

Outcome Measures

Primary Outcomes (3)

  • Numeric pain rate scale (NPRS)

    The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. the NPRS is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    upto 3 weeks

  • Neck Disability index (NDI)

    The results of this questionnaire have been utilized to evaluate the disability. It consists of 10 items: 7 linked to activities of daily living, 2 to pain, and 1 to concentration. From 0 to 5, each item received a score. Higher scores corresponded to more disability, and the total score was reported as a percentage.

    upto 3 weeks

  • Universal Goniometer

    An instrument called a goniometer is used to measure a joint's range of motion. Physical therapists typically use a goniometer to measure a range of motion. At the initial evaluation, the therapist can determine the possible range of motion using a goniometer . Range of motion: Side flexion and Rotation of neck measured with Goniometer.

    upto 3 weeks

Study Arms (2)

Group A: Electro Dry Needling

EXPERIMENTAL

Group A: will receive Electro Dry Needling along with conventional physiotherapy. The parameters for Electro dry needling will be needles of 30×0.25 mm, 50×0.25 mm sizes, Frequency 80-100 Hz, Duration 10-20 minutes and intensity as tolerated.

Procedure: Electro Dry Needling

Group B: Dry Needling

ACTIVE COMPARATOR

Group B will receive Dry Needling along with conventional Physiotherapy in which parameters will be dry needles will be 30×0.25 and 50×0.25 mm sizes, Frequency 80-100 Hz, Duration 10-20 minutes and intensity as tolerated.

Procedure: Dry Needling

Interventions

Standard Physiotherapy: It will include Hot pack (10 min), Stretching of levator scapulae (3 times with 30 seconds hold), Scapular stabilization exercises (10 times with 5 seconds hold). Scapular Stabilization exercises will be comprised of four exercise programs. The participants will sit on the knees in 90° flexion position, and a Swiss ball will be propped up between the stomach and chest.

Group A: Electro Dry Needling
Dry NeedlingPROCEDURE

Dry Needling

Group B: Dry Needling

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ranges of 18-45 years
  • Both genders, males and females
  • Positive Levator Scapular length Test (7)
  • Positive Simon's criteria for Levator scapulae
  • Neck pain -NPRS \< 7 (8)
  • Neck and upper back pain for at least 3months.
  • Examination - Increased muscle tone and tenderness at neck and upper back
  • Reduced ROM-Side flexion and Rotation of neck
  • Non traumatic unilateral mechanical neck pain of three or more months of duration, presenting an latent MTrP in the levator scapulae muscle on the painful side

You may not qualify if:

  • Neuropathies
  • Radiated pain towards the arm
  • Vertebral fractures
  • Traumatic neck injury
  • whiplash injury (9)
  • previous surgical procedures in the cervical spine
  • Previous cognitive and functional disorders
  • psychological disorders (mood and psychotic disorders such as schizophrenia, depression,and anxiety disorders),
  • Fibromyalgia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aqsa Clinic

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

  • Garcia-de-Miguel S, Pecos-Martin D, Larroca-Sanz T, Sanz-de-Vicente B, Garcia-Montes L, Fernandez-Matias R, Gallego-Izquierdo T. Short-Term Effects of PENS versus Dry Needling in Subjects with Unilateral Mechanical Neck Pain and Active Myofascial Trigger Points in Levator Scapulae Muscle: A Randomized Controlled Trial. J Clin Med. 2020 Jun 1;9(6):1665. doi: 10.3390/jcm9061665.

    PMID: 32492884BACKGROUND
  • Hernandez-Secorun M, Abenia-Benedi H, Borrella-Andres S, Marques-Garcia I, Lucha-Lopez MO, Herrero P, Iguacel I, Tricas-Moreno JM, Hidalgo-Garcia C. Effectiveness of Dry Needling in Improving Pain and Function in Comparison with Other Techniques in Patients with Chronic Neck Pain: A Systematic Review and Meta-Analysis. Pain Res Manag. 2023 Aug 23;2023:1523834. doi: 10.1155/2023/1523834. eCollection 2023.

    PMID: 37664417BACKGROUND
  • ALchlaihawi A, Tajali SB, Malmir K, Mahdi TS (2023) Effects of Dry Needling and Dry Needling Combined with Electrical Stimulation on Pain and Function in Patients with Subacute Musculoskeletal Neck Pain Following Myofascial Trigger Points. History of Medicine 9(1): 1845-1858. https://doi.org/10.17720/24095834.v9.1.2023.237

    BACKGROUND
  • Song Young-mun, Weon Jong-hyuck, Jung Do-young. Reliability of a New Test of Levator Scapula Muscle Length. J Musculoskelet Sci Technol 2019;3(1):1-6. https://doi.org/10.29273/jmst.2019.3.1.1

    BACKGROUND
  • Gattie E, Cleland JA, Snodgrass S. The Effectiveness of Trigger Point Dry Needling for Musculoskeletal Conditions by Physical Therapists: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Mar;47(3):133-149. doi: 10.2519/jospt.2017.7096. Epub 2017 Feb 3.

    PMID: 28158962BACKGROUND
  • 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

MeSH Terms

Conditions

Neck Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Aqsa Wahid, MSPT*

    Riphah International University,Lahore

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 14, 2024

Study Start

June 30, 2024

Primary Completion

September 30, 2024

Study Completion

October 10, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations