NCT07150143

Brief Summary

This randomized, double-blinded controlled trial aims to investigate the comparative effects of connective tissue massage and physical modalities, when combined with cervical and scapulothoracic stabilization exercises, in individuals with chronic non-specific neck pain. A total of 51 participants aged 18-65 years will be randomly assigned into three groups. Group 1 will perform stabilization exercises alone, Group 2 will receive stabilization exercises plus connective tissue massage, and Group 3 will receive stabilization exercises plus electrotherapy modalities (infrared, continuous ultrasound, and TENS). The interventions will be conducted twice weekly for 8 weeks, and participants will also perform home-based exercises daily. Primary outcomes include pain, disability, and endurance, while secondary outcomes focus on quality of life, cervical range of motion, and scapular function.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress62%
Sep 2025Oct 2026

First Submitted

Initial submission to the registry

August 24, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

September 12, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

August 24, 2025

Last Update Submit

September 14, 2025

Conditions

Keywords

non-specific neck painscapulothoracic stabilization exercisesconnective tissue massageelectrotherapy

Outcome Measures

Primary Outcomes (4)

  • Neck Disability Index

    To assess disability in neck pain, only the Neck Disability Index (NDI), which evaluates current pain and disability, was used. The NDI consists of 10 items grouped into 6 subdomains. Each item is scored on a scale from 0 to 5, with higher scores indicating greater levels of disability.

    From enrollment to the end of treatment at 8 weeks

  • Deep Cervical Flexor Test

    To evaluate deep neck flexor muscle endurance, the Deep Cervical Flexor Test was used. This test assesses the maximal contraction capacity of the deep cervical flexor muscles. It is performed in the supine position, with the participant lifting the head approximately 2.5 cm off the surface while maintaining chin retraction. The examiner places a hand under the participant's occiput. The test is terminated when cervical flexion is lost or the participant's head touches the examiner's hand, and the duration is recorded in seconds.

    From enrollment to the end of treatment at 8 weeks.

  • Cervical Range of Motion Assessment

    Cervical range of motion was assessed using a universal goniometer. The participant was seated in an upright position, and measurements were taken for cervical flexion, extension, right and left rotation, and right and left lateral flexion. For flexion and extension, the acromion was accepted as the pivot point, with the stationary arm held parallel to the ground and the movable arm aligned with the ear line. For rotation, a straight rod was placed between the participant's teeth, the midline of the head was accepted as the pivot point, the stationary arm was kept parallel to the ground, and the movable arm was aligned with the rod. For lateral flexion, the spinous process of C7 was accepted as the pivot point, the stationary arm was positioned parallel to the ground, and the movable arm was aligned with the spinous processes of the cervical vertebrae. Care was taken to ensure that the head was not rotated during the measurements.

    From enrollment to the end of treatment at 8 weeks

  • Bournemouth Neck Questionnaire

    For pain assessment, the Bournemouth Neck Questionnaire, which focuses on the participant's current symptoms over the past week, was used. The questionnaire evaluates aspects such as onset, localization, duration, type and characteristics of pain, aggravating and relieving factors, history of previous treatments, and accompanying symptoms. The Bournemouth Neck Questionnaire consists of 7 items, each scored on a scale from 0 to 10. The maximum score is 70, with higher scores indicating greater disability.

    From enrollment to the end of treatment at 8 weeks.

Secondary Outcomes (4)

  • Quality of Life Assessment

    From enrollment to the end of treatment at 8 weeks.

  • Lateral Scapular Slide Test

    From enrollment to the end of treatment at 8 weeks.

  • Scapular Dyskinesis Test

    From enrollment to the end of treatment at 8 weeks.

  • Scapular Retraction Test

    From enrollment to the end of treatment at 8 weeks.

Study Arms (3)

Exercise

ACTIVE COMPARATOR

Each exercise session lasts 50 minutes, consisting of 10 minutes of warm-up, 30 minutes of stabilization exercises, and 10 minutes of cool-down. Stabilization exercises will be selected from an exercise pool according to the individual's needs, with progression ensured throughout the program. The exercises will be administered face-to-face twice a week for eight weeks, and participants will be provided with illustrated brochures and instructed to perform a one-hour home exercise program daily.

Other: Exercise

Exercise, and Connective tissue massage

EXPERIMENTAL

Each exercise session lasts 50 minutes, consisting of 10 minutes of warm-up, 30 minutes of stabilization exercises, and 10 minutes of cool-down. Stabilization exercises will be selected from an exercise pool according to the individual's needs, with progression ensured throughout the program. The exercises will be administered face-to-face twice a week for eight weeks, and participants will be provided with illustrated brochures and instructed to perform a one-hour home exercise program daily. In this group, in addition to these exercises, connective tissue massage will be applied, starting from the basic regions and gradually incorporating other regions.

Other: ExerciseOther: Connective tissue massage

Exercise, and Electro-physical modalities

EXPERIMENTAL

Each exercise session lasts 50 minutes, consisting of 10 minutes of warm-up, 30 minutes of stabilization exercises, and 10 minutes of cool-down. Stabilization exercises will be selected from an exercise pool according to the individual's needs, with progression ensured throughout the program. The exercises will be administered face-to-face twice a week for eight weeks, and participants will be provided with illustrated brochures and instructed to perform a one-hour home exercise program daily. Also, the electrotherapy program consists of 20 minutes of infrared therapy, continuous ultrasound will be applied to the right and left sides for 7 minutes each at an intensity of 2 W/cm², and 20 minutes of conventional TENS will be administered to the painful area.

Other: ExerciseOther: Infrared therapyOther: Continuous ultrasoundOther: Conventional TENS

Interventions

Each exercise session lasts 50 minutes, consisting of a 10-minute warm-up, 30 minutes of stabilization exercises, and a 10-minute cool-down. Stabilization exercises are selected from an exercise pool according to the individual's needs, with progression ensuring throughout the program. The exercises will be administered face-to-face twice a week for eight weeks, and participants will be provided with illustrated brochures and instructed to perform a one-hour home exercise program daily.

ExerciseExercise, and Connective tissue massageExercise, and Electro-physical modalities

Connective tissue massage will be applied, starting from the basic regions and gradually incorporating other regions.

Exercise, and Connective tissue massage

Infrared therapy will be applied for 20 minutes

Exercise, and Electro-physical modalities

Continuous ultrasound will be applied to the right and left sides for 7 minutes each at an intensity of 2 W/cm².

Exercise, and Electro-physical modalities

20 minutes of conventional TENS will be administered to the painful area.

Exercise, and Electro-physical modalities

Eligibility Criteria

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

You may qualify if:

  • Being between 18 and 65 years of age,
  • Having non-specific chronic neck pain localized to the posterior cervical spine between the occipital region and the spinous process of the first thoracic vertebra,
  • Being able to cooperate with the assessments to be performed in the study.

You may not qualify if:

  • Neck pain resulting from trauma within the past 6 months;
  • A history of surgery related to cervical problems;
  • Clinical signs of cervical radiculopathy and/or myelopathy;
  • Inflammatory arthritis involving the cervical spine;
  • Tumors or infections of the cervical spine;
  • Vertebrobasilar artery insufficiency;
  • Neurological disorders (such as multiple sclerosis, Parkinson's disease, or syringomyelia);
  • Congenital anomalies affecting the spine; systemic diseases (such as diabetes mellitus);
  • Shoulder pathologies (including tendinitis, bursitis, or capsulitis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fenerbahçe Üniversitesi

Ataşehir, Istanbul, 34734, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Burcu AKKURT, PhD

    Fenerbahçe University

    STUDY DIRECTOR

Central Study Contacts

Burcu AKKURT, PhD

CONTACT

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 24, 2025

First Posted

September 2, 2025

Study Start

September 12, 2025

Primary Completion

November 1, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations