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临床试验/NCT07477145
NCT07477145尚未招募不适用

Effect of Body Mind Exercises and Specific Neck Exercises in Chronic Mechanical Neck Pain

Cairo University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年3月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Pain Intensity

研究概览

简要总结

To investigate the effect of body mind exercise and specific neck exercises in chronic mechanical neck pain on neck pain severity, functional disability, neck flexion range of motion, isometric neck muscle strength and quality of life.

详细描述

Chronic mechanical neck pain is one of the most common musculoskeletal disorders affecting middle-aged and older adults and is associated with pain, reduced cervical mobility, functional disability, and decreased quality of life. Exercise therapy is widely recommended as a first-line conservative treatment for chronic neck pain. Previous studies have shown that both specific neck exercises and general physical activity can reduce pain and improve functional outcomes.

Body-mind exercises, which combine physical movement with focused attention and breathing control, may provide additional benefits by improving both physical and psychological aspects of chronic pain. However, the comparative effectiveness of body-mind exercises and specific neck exercises when combined with conventional physical therapy remains unclear.

The aim of this randomized controlled trial is to investigate the effect of body-mind exercises and specific neck exercises on pain intensity, functional disability, cervical range of motion, isometric neck muscle strength, and quality of life in individuals with chronic mechanical neck pain.

A total of 80 participants aged 50 to 65 years with chronic mechanical neck pain will be recruited and randomly allocated into four groups using a parallel-group design. Group A will receive conventional physical therapy alone. Group B will receive conventional physical therapy combined with body-mind exercises in the form of mindful aerobic treadmill walking. Group C will receive conventional physical therapy combined with specific cervical and scapular stabilization exercises. Group D will receive a combination of conventional physical therapy, body-mind exercises, and specific neck exercises.

All interventions will be performed over a treatment period of six weeks. Outcome measures will include pain intensity measured by the Numeric Pain Rating Scale (NPRS), functional disability assessed by the Neck Disability Index (NDI), cervical range of motion measured using a Cervical Range of Motion (CROM) device, isometric neck muscle strength measured using a handheld dynamometer, and quality of life assessed using the RAND-36 Health Survey. Measurements will be taken before the intervention and after completion of the six-week treatment period.

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
Single (Outcomes Assessor)

盲法说明

Due to the nature of the exercise interventions, participants and treating therapists cannot be blinded. However, the outcome assessor responsible for measuring pain, cervical range of motion, and neck muscle strength will be blinded to group allocation to reduce measurement bias.

入排标准

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

入选标准

  • Adults aged between 50-65 years
  • Diagnosis of chronic mechanical neck pain (pain duration ≥ 3 months)
  • Pain intensity of at least 3/10 on the NPRS

排除标准

  • History of cervical surgery
  • Specific neck conditions (fractures, neoplasm, infection)
  • Pregnancy
  • Severe cardiopulmonary disease or other systemic illness affecting participation

研究组 & 干预措施

Group D : Combined exercise group.

Experimental

Group D will receive conventional therapy in addition to mindful aerobic exercises, cervical and scapular stabilization.

干预措施: specific neck exercise group (Behavioral)

Group A: Conventional physical therapy group (Control group)

Experimental

Group A will receive conventional therapy which includes: heat therapy (infrared) for 10 minutes, massage therapy 10 min, stretching of neck (Scalene, SCM, UFT, Levator scapulae) and pectoral muscles 20 min.

干预措施: Conventional physical therapy group. (Behavioral)

Group B: Body mind exercises group (mindful aerobic exercises)

Experimental

Group B will receive conventional physical therapy (infrared, massage, and neck stretching) in addition to Body mind exercises (mindful aerobic exercises). The aerobic exercise will be performed at an intensity of at least 60% of maximal oxygen consumption (VO₂ max) to effectively improve cardiorespiratory fitness. The program will include treadmill walking 30 minutes.

干预措施: Conventional physical therapy group. (Behavioral)

Group B: Body mind exercises group (mindful aerobic exercises)

Experimental

Group B will receive conventional physical therapy (infrared, massage, and neck stretching) in addition to Body mind exercises (mindful aerobic exercises). The aerobic exercise will be performed at an intensity of at least 60% of maximal oxygen consumption (VO₂ max) to effectively improve cardiorespiratory fitness. The program will include treadmill walking 30 minutes.

干预措施: Body mind exercises group (mindful aerobic exercises) (Behavioral)

Group C: specific neck exercise group

Experimental

Group C will receive conventional therapy in addition to specific neck exercises. Specific exercises will include: cervical and scapular stabilization exercises.

干预措施: Conventional physical therapy group. (Behavioral)

Group C: specific neck exercise group

Experimental

Group C will receive conventional therapy in addition to specific neck exercises. Specific exercises will include: cervical and scapular stabilization exercises.

干预措施: specific neck exercise group (Behavioral)

Group D : Combined exercise group.

Experimental

Group D will receive conventional therapy in addition to mindful aerobic exercises, cervical and scapular stabilization.

干预措施: Conventional physical therapy group. (Behavioral)

Group D : Combined exercise group.

Experimental

Group D will receive conventional therapy in addition to mindful aerobic exercises, cervical and scapular stabilization.

干预措施: Body mind exercises group (mindful aerobic exercises) (Behavioral)

Group D : Combined exercise group.

Experimental

Group D will receive conventional therapy in addition to mindful aerobic exercises, cervical and scapular stabilization.

干预措施: Combined exercise group. (Behavioral)

结局指标

主要结局

Pain Intensity

时间窗: (pre-intervention) and after 6 weeks (post-intervention).

Numeric Pain Rating Scale (NPRS, Arabic version) 0-10 scale; validated for Arabic-speaking populations (Alghadir et al., 2016)

Quality of Life Measured by RAND-36 Health Survey

时间窗: (pre-intervention) and after 6 weeks (post-intervention).

Measures physical, emotional, and social functioning .

Functional Disability

时间窗: (pre-intervention) and after 6 weeks (post-intervention).

Neck Disability Index (NDI, Arabic version) 10-item questionnaire.

Cervical ROM

时间窗: (pre-intervention) and after 6 weeks (post-intervention).

CROM device. Measures flexion, extension, lateral flexion, rotation; 3 repetitions per movement (Kiatkulanusorn et al., 2023).

Isometric Neck Strength

时间窗: (pre-intervention) and after 6 weeks (post-intervention).

Handheld dynamometer (HHD) Flexion (forehead), Extension (occiput), 3 maximal contractions of 5 sec each, average recorded (Ghamkhar et al., 2011)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

RAMY GNADY I KOMIR

Principal Investigator

Cairo University

研究点 (1)

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