Dry Needling With Percutaneous Electrical Nerve Stimulation + Exercises Verus Therapeutic Execises in Patients With Non-specific Chronic Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Neck Disability Index
研究概览
简要总结
The aim of this study is to compare the effects of applying dry needling with percutaneous electrical nerve stimulation + exercises verus therapeutic execises in patients with non-specific chronic neck pain.
详细描述
Globally, neck pain is considered the fourth leading cause of years lived with disability. It is estimated that up to 70% of the world's population will experience neck pain at least once in their lifetime, and between 50% and 85% of cases will become chronic within a five-year period.
The point prevalence of neck pain in the adult population, aged 15-74 years, ranges from 5.9% to 38.7%. This prevalence has been observed to peak in the 50-74 age group. In 2017, the global age-standardized prevalence and incidence of neck pain were 3551.1 and 806.6 per 100,000 population, respectively.
Dry needling with percutaneous electrical nerve stimulation has positive short-term effects on pain intensity, pain-related disability, and mood in patients with chronic nonspecific neck pain, compared with no or minimal intervention. However, the long-term impact could not be assessed due to a lack of available studies. Furthermore, strong evidence has been found suggesting that dry needling with percutaneous electrical nerve stimulation may improve mental well-being and mood in patients with chronic neck pain, especially in those with pain induced by high levels of stress.
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
- 否
入选标准
- •Men and women aged between 30 and 65 years.
- •A diagnosis of non-specific neck pain,
- •Acceptance and signing of informed consent for voluntary participation in the research study.
- •Not currently receiving physiotherapy.
排除标准
- •Patients undergoing rehabilitative treatment for cervical pathologies.
- •Patients with osteosynthesis material at the cervical level and/or cardiac, epileptic, or tumour-related complications.
- •Patients who have undergone radiotherapy. in the last 6 months.
研究组 & 干预措施
Dry Needling with Percutaneous Electrical Nerve Stimulation (PENS) and Therapeutic Exercises.
Patients assigned to this group (n=50) will receive an intervention in which PENS will be applied for 30 minutes with low frequency parameters (2 Hz) and a pulse width of 120 μs. After 30 minutes of PENS in both groups, the needle will be removed and a compression will be applied for 90 seconds. Once the compression will carried out, the technique will be concluded. Patients will develop a session of PENS and a session with therapeutic exercise once a week.
干预措施: Therapeutic Exercise (Other)
Therapeutic Exercise
These participants (n=50) will engage in an exercise protocol with aerobic, isometric, resistence, strength, and stretching exercises. Participants will perform these exercises with a frequency of 3 times a week for 6 weeks, with each session lasting 30 minutes.
干预措施: Dry Needling with Percutaneous Electrical Nerve Stimulation (PENS) and Therapeutic Exercises. (Other)
结局指标
主要结局
Neck Disability Index
时间窗: At baseline, 6 weeks and 3 months (follow up).
The neck disability index consists of 10 questions addressing functional activities such as personal care, lifting, reading, work, driving, sleeping, recreational, pain intensity, concentration and headache. Each item will be scored on a scale from 0 (no limitation). (severe limitation or inability to perform the activity). The total score will be calculated by summing the item scores, dividing by the maximum possible score of 50 (if all 10 questions are answered), and multiplying by 100 to generate a percentage. A score of 0% indicates full independence, while 100% represents complete dependence.
次要结局
- Pain (Visual Analog Scale)(At baseline, 6 weeks and 3 months (follow up).)
- Quality of Life (SF-36 quality of life questionnaire).(At baseline, 6 weeks and 3 months (follow up).)
- Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index).(At baseline, 6 weeks and 3 months (follow up).)
- Tampa scale for kinesiophobia.(At baseline, 6 weeks and 3 months (follow up).)
- Pain Catastrophizing Scale.(At baseline, 6 weeks and 3 months (follow up).)
- Cervical Range of Motion (Pro Motion Capture. Werium).(At baseline, 6 weeks and 3 months (follow up).)
- Spinal Isometric Strength (SIS).(At baseline, 6 weeks and 3 months (follow up).)
- Neck Flexor Muscle Endurance Test (NFME).(At baseline, 6 weeks and 3 months (follow up).)
- Treatment expectations.(At baseline, 6 weeks and 3 months (follow up).)
- Trigger points.(At baseline, 6 weeks and 3 months (follow up).)
- Pain (Visual Analog Scale)(At baseline, 6 weeks and 3 months (follow up).)
- Quality of Life (SF-36 quality of life questionnaire).(At baseline, 6 weeks and 3 months (follow up).)
- Tampa scale for kinesiophobia.(At baseline, 6 weeks and 3 months (follow up).)
- Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index).(At baseline, 6 weeks and 3 months (follow up).)
- Pain Catastrophizing Scale.(At baseline, 6 weeks and 3 months (follow up).)
- Cervical Range of Motion (Pro Motion Capture. Werium).(At baseline, 6 weeks and 3 months (follow up).)
- Trigger points.(At baseline, 6 weeks and 3 months (follow up).)
- Spinal Isometric Strength (SIS).(At baseline, 6 weeks and 3 months (follow up).)
- Neck Flexor Muscle Endurance Test (NFME).(At baseline, 6 weeks and 3 months (follow up).)
- Treatment expectations.(At baseline, 6 weeks and 3 months (follow up).)
研究者
Adelaida María Castro-Sánchez
PhD
Universidad de Almeria