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热疗治疗急性非特异性颈部疼痛

2026年10月2日 更新者:Nuray Alaca、Acibadem University

浅表热疗应用在急性非特异性颈部疼痛中的短期效果比较——随机对照试验

Neck pain is one of the most common musculoskeletal pain disorders secondary to low back pain. Medical and non-medical treatments such as physiotherapy are applied in its treatment. Patients with nonspecific neck pain (NBA) can be treated with various interventions such as drug therapy, manual therapy, heat and exercise. Although it is frequently used in clinical practice, there is no evidence that superficial thermotherapy (hot or cold) methods effectively relieve neck pain. Therefore, this study aims to compare the short-term effects of superficial hot or cold applications on pain, range of motion and functional status in patients with NBA.

研究概览

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Turkey
      • Istanbul、Turkey、土耳其(türkiye)、+90
        • Nuray ALACA
      • Istanbul、Turkey、土耳其(türkiye)、34752
        • Acibadem University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Being diagnosed with nonspecific neck pain by a doctor,
  • To be between the ages of 18-65,
  • Neck pain lasting for less than 3 month
  • No previous neck or shoulder surgery,
  • No shoulder pain due to any cause,
  • A tumour or inflammatory disease underlying the neck pain not to be found,
  • A clinically underlying stenosis or discogenic problem not to be present.
  • Negative results from the following clinical examination tests;

Spurling test, Lhermitte test, Cervical distraction test, Adson test,

Exclusion Criteria:

  • Not meeting the inclusion criteria,
  • Positive neurological examination (positive motor presence, reflex or sensory abnormalities indicating spinal root compression) or abnormal neurological findings related to nerve compression in the upper limb
  • Systemic rheumatological or metabolic diseases or cancer
  • Refusal to participate in the study,
  • Failure to complete treatment,
  • Having any neurological problem
  • Severe psychological illnesses

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
假比较器:深水集团

An unrefrigerated room temperature Cold Pack will be wrapped in a towel and applied to the patient's posterior neck and back for 15 minutes while the patient is lying face down.

有源比较器:热包集团

Hot pack (55-60 degrees) application will be wrapped in a towel and applied to the back side neck and back of the patient for 15 minutes while the patient is lying face down.

有源比较器:冷包集团

Cold pack application (2-4 degrees) will be wrapped in a towel and applied to the patient's back side neck and back for 15 minutes while the patient is lying prone.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The Numerical Rating Scale (NPRS-11)
大体时间:Change from baseline pain score at 3th day

The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.

Change from baseline pain score at 3th day
Range of Motion
大体时间:Change from baseline range of motion at 3th day

CROM device will be used. The active range of motion of each individual will be measured and measured in accordance with the manufacturer's procedures

Change from baseline range of motion at 3th day
Global Rating of Change scale (Patient Satisfaction)
大体时间:Change from baseline Global Rating of Change scale at 3th day

Patient satisfaction regarding improvement in cervical situtaion will be evaluated by the Global Rating of Change scale. All participants will be asked to rate their condition after a six-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly between -2 to +2, with a higher value indicating better condition in this study.

Change from baseline Global Rating of Change scale at 3th day

次要结果测量

结果测量
措施说明
大体时间
Neck disability index
大体时间:Change from baseline disability scale at 3th day

Since some parts of the 10-item questionnaire could not be answered by the patients (driving, working life), the average neck disability index score will be calculated by dividing the total score by the number of questions answered. The scoring is between 0 and 50. 0 points means the best result, 50 points means the worst result. 0 - 4 points; no disability, 5 - 14 points; mild disability, 15 - 24 points; moderate disability, 25 - 34 points; severe disability, > 35 points; complete disability

Change from baseline disability scale at 3th day
Pressure Pain Threshold
大体时间:Change from baseline Pressure Pain Threshold at 3th day

A digital pressure algometer will be applied to the web space of the cervical opposite the trigger point. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold).

Change from baseline Pressure Pain Threshold at 3th day

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年7月19日

初级完成 (实际的)

2025年6月10日

研究完成 (实际的)

2025年6月10日

研究注册日期

首次提交

2024年7月12日

首先提交符合 QC 标准的

2024年7月12日

首次发布 (实际的)

2024年7月18日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月2日

最后验证

2024年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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