跳至主要内容
临床试验/NCT05893745
NCT05893745招募中不适用

Effectiveness of Dermoneuromodulation Techniques in Patients With Non-specific Chronic Neck Pain: A Randomized Controlled Trial

Ahram Canadian University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Changes in Numeric Pain Rating Scale (NPRS)

研究概览

简要总结

PURPOSE: The purpose of the present study is to investigate the benefit of applying dermoneuromodulation techniques in patients with non-specific chronic neck pain.

BACKGROUND: Chronic neck pain is one of the most commonly reported musculoskeletal pathologies in the general population. It has an immense impact on the physical, social, and psychological aspects and quality of life of the individual and society as a whole. Dermoneuromodulation(DNM) is recently popularising touch based pain relieving approach which is a gentle, structured method of interacting with patient's nervous system to help them resolve pain, regain function, and feel better. It was developed by Diane Jacobs, a Canadian physiotherapist specialised in pain science and the treatment of painful conditions. During her 40 years of practice, Jacobs was interested in Ronald Melzack, who developed the original Gate Control theory of pain along with Patrick Wall, and who later developed the NeuroMatrix model of pain. In 2007, Jacobs made a cadaver study that defined how peripheral cutaneous nerves divide into rami, which spread outward into the underside of skin. This work inspired her to develop a new conceptual approach to manual therapy for patients with pain.

HYPOTHESES We hypothesize that there will be no effect of dermoneuromodulation techniques on clinical outcomes of patients with non-specific chronic neck pain.

RESEARCH QUESTION: Is there a statistically significant effect of dermoneuromodulation techniques on clinical outcomes of patients with non-specific chronic neck pain?

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
25 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Recurrent history of non-specific chronic neck pain (NSCNP) of not less than 3 months duration.
  • Pain level greater than or equal to 5/10 on the Numeric Pain Rating Scale (NPRS).
  • Age between 25 to 40 years.
  • Both male and female participants.
  • Diagnosis of non-specific chronic neck pain confirmed by a licensed physiotherapist or physician using a combination of the following criteria:
  • Absence of specific pathologies or conditions causing neck pain (e.g., disc prolapse, tumor of the cervical spine, whiplash injury, cervical fractures, or cervicogenic headache) as assessed by clinical examination and medical history.
  • Presence of at least three of the following signs and symptoms:
  • Restricted cervical range of motion.
  • Pain provoked or increased with neck movement or sustained neck postures.
  • Palpable muscle tension or tenderness in the neck or upper back region.
  • Referred pain or symptoms to the shoulders, upper back, or arms.
  • Neck pain not attributed to a specific cause after careful evaluation, including imaging studies (e.g., X-ray, MRI, or CT scan) if deemed necessary by the clinician.

排除标准

  • Serious pathology such as specific neck pain due to disc prolapse, tumor of the cervical spine, whiplash injury, cervical fractures, or cervicogenic headache.
  • Any neurological signs consistent with nerve root compression.
  • Prior surgery in the cervical region.
  • Inability to comply with the exercise program or attend scheduled sessions.
  • Contraindications to dermoneuromodulation techniques, such as active skin infections or severe inflammatory skin conditions.

结局指标

主要结局

Changes in Numeric Pain Rating Scale (NPRS)

时间窗: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.

The NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) to measure the intensity of pain.

Changes in Neck Disability Index (NDI)

时间窗: Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.

The NDI is a 10-item questionnaire used to measure functional disability related to neck pain. Each item is scored from 0 to 5, with a total possible score of 50. Higher scores indicate greater disability.

次要结局

  • Chnages in Pressure Pain Threshold (PPT)(Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.)
  • Changes in cervical range of motion(Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.)
  • Changes in Pain Self-Efficacy Questionnaire (PSEQ)(Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.)
  • Changes in Fear-Avoidance Beliefs Questionnaire (FABQ)(Baseline, 2 weeks post-treatment, 4 weeks post-treatment, and 3 months post-treatment.)

研究者

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

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Ahram Canadian University

研究点 (2)

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