Effectiveness of Pressure Biofeedback-Assisted Deep Cervical Flexor Training With and Without Scapular Stabilization Exercises on Pain, Range of Motion and Neck Disability in Cervical Spondylosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Neck Disability - Neck Disability Index (NDI)
研究概览
简要总结
This randomized controlled trial will evaluate the effectiveness of pressure biofeedback-assisted deep cervical flexor training with and without scapular stabilization exercises in patients with cervical spondylosis. The study will compare the effects of the two treatment approaches on pain intensity, cervical range of motion and neck disability.
详细描述
Participants with radiologically confirmed cervical spondylosis will be recruited according to predefined inclusion and exclusion criteria. A total of 44 participants will be recruited, with 22 participants allocated to each group after accounting for an anticipated 10% loss to follow-up. Participants will be randomly allocated using the sealed envelope method into two groups. Group A will receive pressure biofeedback-assisted deep cervical flexor training combined with scapular stabilization exercises and standard physiotherapy. Group B will receive pressure biofeedback-assisted deep cervical flexor training without scapular stabilization exercises, along with standard physiotherapy. Treatment will be provided three times per week for four weeks, with each session lasting approximately 30-40 minutes. Outcomes will be assessed at baseline and after completion of the four-week intervention.
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)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders aged 40-60 years.
- •Presence of chronic neck pain for ≥3 months with NPRS ≥
- •Radiologically confirmed cervical spondylosis, including cervical spine X-ray showing disc space narrowing and/or osteophyte formation.
- •Ability to perform active cervical and shoulder movements without neurological deficits.
- •Willingness to participate in the study and comply with the intervention protocol.
排除标准
- •History of cervical spine surgery or trauma in the past 6 months.
- •Severe neurological involvement, including cervical myelopathy or severe radiculopathy with motor weakness, gait disturbance, or bowel/bladder involvement.
- •Inflammatory or systemic musculoskeletal disorders, e.g., rheumatoid arthritis or ankylosing spondylitis.
- •Current participation in structured neck/shoulder rehabilitation programs.
- •Uncontrolled medical conditions contraindicating exercise, e.g., uncontrolled hypertension or cardiovascular disease.
研究组 & 干预措施
Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization Exerci
干预措施: Scapular Stabilization Exercises (Other)
Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization Exerci
干预措施: Pressure Biofeedback-Assisted Deep Cervical Flexor Training (Other)
Group B: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Standard Physiotherapy
干预措施: Pressure Biofeedback-Assisted Deep Cervical Flexor Training (Other)
Group B: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Standard Physiotherapy
干预措施: Standard Physiotherapy (Other)
Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization Exerci
干预措施: Standard Physiotherapy (Other)
结局指标
主要结局
Neck Disability - Neck Disability Index (NDI)
时间窗: Baseline and 4 weeks of treatment.
Measure: Functional disability related to neck pain measured using the Neck Disability Index.
Pain Intensity - Numeric Pain Rating Scale (NPRS)
时间窗: Baseline and 4 weeks of treatment
Neck pain intensity measured using the 0-10 Numeric Pain Rating Scale.
Universal Goniometer
时间窗: Baseline and 4 weeks of treatment.
Measure: Cervical Range of Motion - Cervical flexion, extension, right/left lateral flexion, and right/left rotation.
Neck Disability - Neck Disability Index (NDI)
时间窗: Baseline and after 4 weeks of treatment.
Measure: Functional disability related to neck pain measured using the Neck Disability Index.
Pain Intensity - Numeric Pain Rating Scale (NPRS)
时间窗: Baseline and after 4 weeks of treatment
Neck pain intensity measured using the 0-10 Numeric Pain Rating Scale
Universal Goniometer
时间窗: Baseline and after 4 weeks of treatment.
Measure Cervical Range of Motion - Cervical flexion, extension, right/left lateral flexion and right/left rotation
次要结局
- The Neck Flexor Endurance Test(Baseline and 4 weeks of treatment)
- The Neck Flexor Endurance Test(Baseline and after 4 weeks of treatment)