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临床试验/NCT03576846
NCT03576846已完成不适用

The Effect of Spinal Manipulative Therapy on Heart Rate Variability and Pain, and the Predictive Value of Conditioned Pain Modulation

Karolinska Institutet4 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2019年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
131
试验地点
4
主要终点
Change in Heart Rate Variability

研究概览

简要总结

This randomized, single-blinded study will investigate the effects of Spinal Manipulative Therapy on Heart Rate Variability and Pain Sensitivity in a population of patients with recurrent and persistent neck pain. Alongside, the study will also develop a clinical test for Conditioned Pain Modulation and investigate its predictive properties.

详细描述

Previously, Spinal Manipulative Therapy (SMT) was thought to mechanically affect the restoration of muscular and joint function, by normalising muscle tension and joint mobility. However, recent research has suggested that SMT may be influencing the incoming/ascending pain signals and/or the excitability of the central pain regulating mechanisms. People with chronic neck/shoulder pain have been found to have a disturbance of the Autonomic Nervous System (ANS). Little is known about the changes in the ANS and its relation to changes in pain in a series of treatments conducted in a clinical setting.

This multicentre randomized controlled clinical trial will be carried out in multimodal primary care clinics where both physiotherapists and chiropractors are consulted for musculoskeletal issues are selected to minimize selection bias from the patient's pre-desired treatment modality.

The subjects will be recruited among patients seeking care for persistent or recurrent Neck pain (NP), either self-selected or through referrals from general practitioners in the local areal. The aim is to study the effect of SMT and stretching exercises compared to stretching exercises alone, two well-known interventions for NP, during a two-week treatment regimen.

The primary outcome is the activity of the autonomic nervous system (Heart Rate Variability (HRV), but also Conditioned Pain Modulation (CPM) will be measured. HRV and CPM will be measured at baseline, prior to the third treatment and after the fourth treatment.

The subjective pain experience will be investigated by using two different instruments accessing pain intensity and the affective quality of pain, asked at the assessments during the two weeks of treatment and 2 months after the period of intervention ends.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The subject will not know the content of the other arm. The care provider cannot be blinded, as he/she will be performing the treatment. The investigator performing the measurements will not be aware of the treatment allocation, and the analyses will be masked for group allocation

入排标准

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

入选标准

  • minimum 18 years,
  • able to read and understand Swedish,
  • persistent or recurrent Neck Pain (duration of current episode more than 6 months and at least one previous episode of NP),
  • no chiropractic treatment during the previous 3 months.

排除标准

  • conditions or medications that will affect the Heart Rate Variability measurements (cardiovascular disease, diabetes, pregnancy, obesity, currently using pain-reducing medication, steroids or antidepressants),
  • all contraindications to manual treatment, (anything that could seriously aggravate the pain (such as inflammatory conditions) or signal cerebrovascular injuries (previous drop attacks or a recent episode of new headache or dizziness).

结局指标

主要结局

Change in Heart Rate Variability

时间窗: 2 weeks, the change is reported between baseline-2 weeks

The variation in beat-to-beat heart rate is an indicator of parasympathetic and sympathetic modulation of the heart rhythm. It is measured as the time between two R-waves on the ECG and measured in ms.

Change in Heart Rate Variability

时间窗: 2 weeks, the change is reported between baseline-2 weeks

The variation in beat-to-beat heart rate is an indicator of parasympathetic and sympathetic modulation of the heart rhythm. It is measured as the time between two R-waves on the ECG and measured in ms.

次要结局

  • Change in Conditioned Pain Modulation, Measured as the Difference in Pain Intensity Between Two Conditions .(The test is done at baseline and again at 2 weeks, and the outcome is the difference between these two scores)
  • Change in Conditioned Pain Modulation, Measured as the Difference in Pain Intensity Between Two Conditions .(The test is done at baseline and again at 2 weeks, and the outcome is the difference between these two scores)

研究者

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

Iben Axen

Associate Professor

Karolinska Institutet

研究点 (4)

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