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临床试验/NCT05605132
NCT05605132招募中不适用

Comparison of the Effects of Proprioception and Tactile Accuracy Training on Proprioception, Range of Motion, Pain and Disability in Patients With Chronic Neck Pain

Hacettepe University2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2023年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
57
试验地点
2
主要终点
pain intensity

研究概览

简要总结

It is known that tactile acuity and proprioceptive sense decrease in patients with chronic neck pain. However, sensory re-training in patients with chronic neck pain has not been given sufficient importance. The effects of proprioceptive and tactile acuity training on pain intensity in patients with chronic neck pain will be compared in this study. Eligible participants will be divided into three groups as follows: Proprioceptive Training Group (PTG), Tactile Acuity Training Group (TAG), and Control Group (CG). The randomization will be performed using the block randomization method to obtain an equal number of participants in the groups. Each participant will be evaluated two times at a 4-week interval. Participants will be evaluated regarding subjective pain intensity by using a Numerical Rating Scale, temporal summation, and conditioned pain modulation using an algometer (JTECH Medical-Algometer Commander, USA). Neck proprioception exercises will be applied to the patients in the PTG at 3 days a week for 4 weeks. Tactile acuity training will be applied to the patients in the TAG 3 days a week for 4 weeks. Between the two assessments, the Control Group will not receive any treatment.

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 (Participant)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •to be aged between 20-60 years old
  • •Pain limited to the posterior of the cervical region.
  • •Pain that lasts longer than 3 months
  • •Pain severity of 3 or higher on the Visual Analog Scale

排除标准

  • •Malignant tumor in any part of the body (no screening will be performed for the presence of tumor and patients diagnosed with tumors before the study will not be included).
  • •Vertebral fractures
  • •Fibromyalgia
  • •chronic fatigue syndrome
  • •History of surgery in the neck or shoulder area
  • •Radicular pain
  • •Neurological deficit of disc pathologies
  • •Spinal stenosis
  • •Spondylolisthesis
  • •Pronounced cervical kyphosis
  • •Significant scoliosis involving the cervical region

研究组 & 干预措施

Proprioceptive Training Group

Experimental

oculomotor exercises will be applied to the participants three times a week for four weeks.

oculomotor exercises:

head relocation gaze stability eye follow saccadic eye movement head and eye coordination

干预措施: Proprioceptive Training Exercise (Other)

Tactile Acuity Training

Experimental

Participants will be requested to lie face down. Five points will be marked in the painful areas on the right and left sides of the neck. The distance between the points will equal the two-point discrimination value. A photograph of the neck will be taken. The patient will not see his/her own neck during the application but see the photograph of his/her neck. The points will be touched lightly with two different stimuli (a pen with a 2 mm diameter and a mushroom probe with an 11 mm diameter). Participants will be asked about the location and type of the stimuli. The interstimulus interval will be 15 seconds. If more than 90% of correct answers are obtained, the distance between the points will be reduced by 10%. The training will be performed in three separate blocks, a total of 72 stimuli (block duration = 6 minutes, rest time between blocks = 3 minutes, number of stimuli applied in each block = 24 stimuli). The treatment time will be 24 minutes.

干预措施: Tactile Acuity Training (Other)

Control Group

Sham Comparator

The participants will be evaluated two times at 4-week intervals. No intervention will be applied during the time frame.

干预措施: Control Group (Other)

结局指标

主要结局

pain intensity

时间窗: Change form baseline at 4 weeks

It will be evaluated using a Numerical Rating Scale (0 indicate no pain, 10 indicate most vulnerable pain)

次要结局

  • conditioned pain modulation(Change form baseline at 4 weeks)
  • temporal summation(Change form baseline at 4 weeks)
  • neck disability(Change form baseline at 4 weeks)
  • pressure pain threshold(Change form baseline at 4 weeks)

研究者

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

Kübra Canli

Research Assistant

Hacettepe University

研究点 (2)

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