Effects of Connective Tissue Massage and Physical Modalities Combined With Stabilization Exercises in Chronic Neck Pain

NCT ID: NCT07150143

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-12

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Chronic non-specific neck pain is a prevalent musculoskeletal disorder that adversely affects pain, functional capacity, and quality of life. Stabilization-based exercise programs are commonly recommended; however, the added benefits of connective tissue massage and physical modalities require further investigation.

This randomized, double-blinded controlled trial is designed to compare the effects of (1) stabilization exercises alone, (2) stabilization exercises combined with connective tissue massage, and (3) stabilization exercises combined with electrotherapy modalities (infrared therapy, continuous ultrasound, and TENS) on clinical outcomes in individuals with chronic non-specific neck pain.

A total of 51 participants between 18 and 65 years of age will be randomly allocated into three equal groups. All groups will receive supervised exercise sessions twice weekly for 8 weeks, each lasting 50 minutes (10 minutes of warm-up, 30 minutes of cervical and scapulothoracic stabilization, and 10 minutes of cool-down). Additionally, participants will be instructed to perform a one-hour home exercise program daily, supported with illustrated brochures.

The primary outcomes are:

* Pain (Bournemouth Neck Questionnaire)
* Disability (Neck Disability Index)
* Endurance (Deep Cervical Flexor Test)

The secondary outcomes are:

* Quality of life (WHOQOL-BREF)
* Cervical range of motion
* Scapular function (Lateral Scapular Slide Test and Scapular Dyskinesis Test)

By comparing these approaches, the study aims to determine whether the addition of connective tissue massage or physical modalities enhances the therapeutic effects of stabilization exercises on pain, function, and endurance in patients with chronic non-specific neck pain.

Conditions

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Non-specific Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Exercise

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.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

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.

Exercise, and Connective tissue massage

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

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.

Connective tissue massage

Intervention Type OTHER

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

Exercise, and Electro-physical modalities

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

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.

Infrared therapy

Intervention Type OTHER

Infrared therapy will be applied for 20 minutes

Continuous ultrasound

Intervention Type OTHER

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

Conventional TENS

Intervention Type OTHER

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

Interventions

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Exercise

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.

Intervention Type OTHER

Connective tissue massage

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

Intervention Type OTHER

Infrared therapy

Infrared therapy will be applied for 20 minutes

Intervention Type OTHER

Continuous ultrasound

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

Intervention Type OTHER

Conventional TENS

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fenerbahce University

OTHER

Sponsor Role lead

Responsible Party

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Burcu AKKURT

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burcu AKKURT, PhD

Role: STUDY_DIRECTOR

Fenerbahçe University

Locations

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Fenerbahçe Üniversitesi

Ataşehir, Istanbul, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Burcu AKKURT, PhD

Role: CONTACT

+905536046713

Facility Contacts

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Burcu AKKURT, Assistant Professor

Role: primary

05536046713

Role: backup

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2015-KAEK-63-22-07

Identifier Type: -

Identifier Source: org_study_id

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