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临床试验/NCT07368517
NCT07368517
已完成
不适用

Effect of Dry Needling in the Treatment of Patients With Mechanical Neck Pain

Deraya University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月5日最近更新:

概览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Change in Neck Disability Index (NDI)

概览

简要总结

Mechanical neck pain is one of the most common musculoskeletal disorders among adults. It is characterized by pain and stiffness in the cervical region, often related to poor posture, repetitive movements, or prolonged sitting. The condition can lead to functional limitations and decreased quality of life.

This randomized controlled clinical trial aims to evaluate the effectiveness of dry needling therapy on pain intensity, cervical range of motion, and functional ability in patients with mechanical neck pain. Forty participants aged 25 - 65 years will be randomly assigned to two groups. Group A will receive dry needling combined with neck exercises, while Group B will receive transcutaneous electrical nerve stimulation (TENS), ultrasound, and the same neck exercise program. Both groups will undergo treatment three times per week for four weeks.

Primary outcomes include changes in the Neck Disability Index (NDI), pressure pain threshold (PPT) measured by algometer, and cervical range of motion (CROM). The study will determine whether dry needling provides superior clinical improvement compared with conventional electrotherapy and exercise.

详细描述

Mechanical neck pain (MNP) affects a large proportion of adults between 25 and 65 years of age. It is commonly associated with sustained poor posture, repetitive movement, or prolonged sitting, leading to muscular tightness and joint stiffness in the cervical region. Patients typically present with pain, limited cervical mobility, and decreased ability to perform daily activities.

Dry needling is a minimally invasive technique that involves inserting fine monofilament needles into myofascial trigger points to reduce muscle tension, improve circulation, and alleviate pain. It is increasingly used in physiotherapy practice as a targeted intervention for musculoskeletal pain conditions. By releasing taut muscle bands, dry needling is believed to normalize muscle tone and restore normal movement patterns.

The current randomized controlled trial is designed to assess the effectiveness of dry needling combined with therapeutic exercise compared with conventional physiotherapy including TENS, ultrasound, and the same exercise regimen. Forty participants with mechanical neck pain will be randomly allocated into two equal groups (n = 20 per group).

Group A (Experimental): Dry needling will be applied to the upper trapezius and deltoid muscles under aseptic technique. Each needle will be inserted 5 - 10 mm deep and retained for approximately 30 seconds. This intervention will be combined with a neck exercise program consisting of chin-in exercises (3 sets × 10 repetitions, 5-second hold) and a muscle-energy technique for the upper trapezius (3 repetitions per side, 5 - 10 second holds).

Group B (Active Comparator): Participants will receive TENS at 80 - 100 Hz frequency, 100 µs pulse duration for 20 minutes, and pulsed ultrasound at 1 MHz, 1.0 - 1.5 W/cm² for 5 minutes. The same chin-in and muscle-energy exercise protocol will be applied.

Both groups will receive three sessions per week for four weeks. Assessments will include:

Pain and disability using the Neck Disability Index (NDI).

Pressure pain threshold (PPT) using a handheld algometer.

Cervical range of motion (CROM) using a cervical range-of-motion device.

Outcomes will be recorded at baseline and after four weeks of treatment. It is hypothesized that dry needling will produce greater reductions in pain and disability and larger improvements in cervical motion compared with conventional therapy.

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
None

盲法说明

This is an open-label study. Both participants and care providers are aware of the assigned interventions due to the physical nature of the treatments.

入排标准

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

入选标准

  • Medically stable individuals who provide written informed consent to participate in the study.
  • Age between 25 and 65 years.
  • Both male and female participants.
  • Patients diagnosed with mechanical neck pain lasting more than three months.
  • Presence of myofascial trigger points in the upper trapezius or cervical muscles confirmed by palpation.
  • Ability to follow treatment instructions and attend all scheduled sessions.

排除标准

  • History of neck surgery or cervical spine fracture.
  • Previous dry needling or invasive therapy for neck pain in the past six months.
  • History of neurological disorders (e.g., cervical radiculopathy, myelopathy).
  • Current acute infection, skin disease, or open wound in the neck or shoulder region.
  • Use of anticoagulant medication or any bleeding disorder.
  • Pregnancy or suspected pregnancy.
  • Any systemic illness (e.g., diabetes mellitus, rheumatoid arthritis) that may affect healing or pain perception.

研究组 & 干预措施

Dry Needling with Exercise

Experimental

Participants in this group will receive dry needling to the upper trapezius and deltoid muscles under aseptic conditions. Needles will be inserted 5-10 mm deep and held for approximately 30 seconds, then discarded.

This intervention will be combined with a neck exercise program including chin-in exercises (3 sets × 10 repetitions, 5-second holds) and a muscle energy technique (3 repetitions per side, holding 5-10 seconds).

Sessions: three per week for four weeks.

干预措施: Dry Needling with Exercise (Other)

Conventional Physiotherapy with Exercise

Active Comparator

Participants in this group will receive conventional physiotherapy including transcutaneous electrical nerve stimulation (TENS) at 80-100 Hz, 100 µs pulse duration for 20 minutes, and pulsed ultrasound at 1 MHz, 1.0-1.5 W/cm² for 5 minutes.

The same exercise program will be applied (chin-in and muscle-energy technique).

Sessions: three per week for four weeks.

干预措施: Conventional Physiotherapy with Exercise (Other)

结局指标

主要结局

Change in Neck Disability Index (NDI)

时间窗: Baseline and after 4 weeks of treatment

The Neck Disability Index (NDI) is a 10-item self-reported questionnaire used to assess how mechanical neck pain affects daily activities. Each item is scored from 0 to 5, and total scores are converted to a percentage, with higher values indicating greater disability. It is a valid and reliable tool for monitoring functional improvement after physiotherapy interventions.

Change in Pressure Pain Threshold (PPT)

时间窗: Baseline and after 4 weeks of treatment

Pressure Pain Threshold (PPT) will be measured using a digital algometer. It represents the minimum pressure that elicits pain and provides an objective assessment of muscle tenderness and trigger point sensitivity. Higher values indicate reduced pain sensitivity. Measurements will be taken over the upper trapezius muscle in kg/cm².

Change in Cervical Range of Motion (CROM)

时间窗: Baseline and after 4 weeks of treatment

Cervical Range of Motion (CROM) will be assessed using a CROM device that quantifies cervical flexion, extension, lateral flexion, and rotation. Measurements will be taken in degrees. The device provides objective and reproducible data on cervical spine mobility and is used to evaluate the effect of treatment on movement limitations.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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