NCT07169084

Brief Summary

Chronic neck pain is a common musculoskeletal disorder that negatively affects daily life and quality of life. Exercise and manual therapy are widely used treatment strategies, but there is limited evidence comparing different rehabilitation approaches. This randomized controlled trial aims to compare the effects of instrument-assisted soft tissue mobilization and manual therapy on pain, functional status, cervical muscle endurance, and range of motion in individuals with chronic neck pain. Twenty-four participants will be randomly assigned to two groups and receive treatment three times per week for four weeks. Assessments will include the Visual Analog Scale, Neck Disability Index, cervical muscle endurance tests, and goniometric range of motion. The results are expected to support evidence-based strategies for managing chronic neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 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

September 1, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

February 9, 2026

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

September 5, 2025

Last Update Submit

February 5, 2026

Conditions

Keywords

Rehabilitation ApproachesManual TherapyInstrument-Assisted Soft Tissue MobilizationPhysical TherapyMusculoskeletal Disorders

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS), 0-10 cm (0 = no pain, 10 = worst pain imaginable)

    The VAS will be used to assess the intensity of neck pain. A higher score indicates greater pain intensity.

    Change from baseline to 4 weeks

Study Arms (2)

Manual Therapy Group

EXPERIMENTAL

Participants receive manual therapy interventions, including posterior-anterior mobilizations, lateral glides, suboccipital release, and traction techniques based on Maitland principles.

Other: Manual Therapy

Instrument-Assisted Soft Tissue Mobilization Group

EXPERIMENTAL

Participants receive instrument-assisted soft tissue mobilization using specialized tools on the cervical and upper thoracic regions.

Other: Instrument-Assisted Soft Tissue Mobilization (IASTM)

Interventions

Manual mobilization techniques applied to the cervical and upper thoracic regions, 3 sessions/week for 4 weeks.

Manual Therapy Group

Mobilization applied with instruments to cervical and upper thoracic muscles, 3 sessions/week for 4 weeks.

Instrument-Assisted Soft Tissue Mobilization Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-40 years
  • Diagnosis of chronic neck pain (≥12 weeks duration)
  • Pain intensity ≥ 3 cm on the Visual Analog Scale (VAS)
  • Voluntary participation and signed informed consent

You may not qualify if:

  • Previous cervical spine surgery
  • History of acute trauma, fracture, or dislocation in the cervical region
  • Presence of neurological deficit, inflammatory disease, or systemic rheumatic condition
  • Malignancy, severe cardiovascular or neurological disorder
  • Participation in a similar treatment program within the past 6 months
  • Current use of corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Atlas University

Kâğıthane, Istanbul, 34408, Turkey (Türkiye)

Location

Related Publications (3)

  • Mylonas K, Angelopoulos P, Billis E, Tsepis E, Fousekis K. Combining targeted instrument-assisted soft tissue mobilization applications and neuromuscular exercises can correct forward head posture and improve the functionality of patients with mechanical neck pain: a randomized control study. BMC Musculoskelet Disord. 2021 Feb 21;22(1):212. doi: 10.1186/s12891-021-04080-4.

  • Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.

  • Tunwattanapong P, Kongkasuwan R, Kuptniratsaikul V. The effectiveness of a neck and shoulder stretching exercise program among office workers with neck pain: a randomized controlled trial. Clin Rehabil. 2016 Jan;30(1):64-72. doi: 10.1177/0269215515575747. Epub 2015 Mar 16.

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 11, 2025

Study Start

September 1, 2025

Primary Completion

November 15, 2025

Study Completion

December 15, 2025

Last Updated

February 9, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations