跳至主要内容
临床试验/NCT07150143
NCT07150143招募中不适用

Comparative Effects of Connective Tissue Massage and Physical Modalities Added to Cervical and Scapulothoracic Stabilization Exercises on Pain, Function, and Endurance in Individuals With Chronic Neck Pain

Fenerbahce University1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2025年9月12日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
27
试验地点
1
主要终点
Neck Disability Index

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Neck Disability Index

时间窗: From enrollment to the end of treatment at 8 weeks

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.

Deep Cervical Flexor Test

时间窗: From enrollment to the end of treatment at 8 weeks.

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.

Cervical Range of Motion Assessment

时间窗: From enrollment to the end of treatment at 8 weeks

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.

Bournemouth Neck Questionnaire

时间窗: From enrollment to the end of treatment at 8 weeks.

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.

次要结局

  • 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.)
  • 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.)

研究者

发起方
Fenerbahce University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burcu AKKURT

Assistant Professor

Fenerbahce University

研究点 (1)

Loading locations...

相似试验