Does Acupuncture Activate Endogenous Pain Inhibition in Chronic Whiplash Associated Disorders? A Randomized Cross-over Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- the change in Conditioned pain modulation
研究概览
简要总结
This physiological study examines whether acupuncture exerts short-term effects of analgesic mechanisms in patients with chronic whiplash pain. More specifically, it is examined whether acupuncture activates brain-orchestrated pain inhibitory action.
详细描述
Many patients with chronic pain, including those with chronic whiplash-associated disorders (WAD), show features of central sensitization (CS), a process characterized by generalized hypersensitivity of the somatosensory system. it would be worthwhile identifying treatments able of activating the dysfunctional endogenous pain inhibition in patients with CS and chronic WAD.
Acupuncture is a treatment method widely used for patients with chronic pain, including those with chronic WAD. The effectiveness of acupuncture for the treatment of chronic (neck) pain is supported by several randomized controlled clinical trials, systematic reviews including meta-analyses. However, the effect-sizes are rather small and only short-term effects have been shown consistently.
A randomized cross-over trial comparing acupuncture with relaxation is conducted in order to examine whether acupuncture vs. relaxation for patients with chronic WAD results in:
- Immediate activation of endogenous pain inhibition (i.e. conditioned pain modulation);
- Concomitant pain relief;
- And reduced disability level. Further it is examined whether acupuncture vs. relaxation results in different autonomic nervous system responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, 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
- •a diagnosis of chronic WAD grade 1 to 3 according to the criteria as defined by the Quebec Task Force classification
- •chronic neck pain and WAD persisting for at least 3 months
- •age between 18 and 65 years
排除标准
- •classified as WAD grade 4 (neck complaints including fracture or dislocation, or injury to the spinal cord)
- •initiated a new conventional therapy during the study period
- •taking analgesic drugs 48 hours before testing and/or nicotine, alcohol and caffeine 24 hours before testing
研究组 & 干预措施
acupuncture
All patients were treated at the basic points bilaterally situated in the local region (neck), distal region (low back, arms and legs) and ear. In addition, acupuncture treatment was performed according to the rules of traditional Chinese medicine and was semi-standardized. This means that the therapist was allowed to choose from a list of the following acupuncture points: GV14, Huatuojiaji C1-C7, GB20, SI11, GB21, TE15, SI14, BL17, MT10, SI3, BL64, TE5, GB41, Zero point, Jerome point, C0. The combination of acupuncture points were chosen individually, according to the patients' self-reported symptoms. In order to obtain the required information, patients had to fill out a Margolis pain diagram, and the acupuncturist questioned the patient and performed a tongue- and pulse diagnosis.
干预措施: acupuncture (Other)
relaxation
For the relaxation treatment the method of guided imagery is applied. Guided imagery is a system of visualization. During guided imagery relaxation, the patient's state of consciousness is similar to one which occurs in meditative status. Patients are instructed to listen to a CD with relaxation music (Arcade TV-CD Ad Vissesr's Brainsessions, track 3). Patients will sit in an identical position like during the acupuncture treatment (i.e. on a relaxation chair) and listened to the audio CD by headphone.
干预措施: relaxation (Behavioral)
结局指标
主要结局
the change in Conditioned pain modulation
时间窗: measured prior to (week 1 and week 2) and immediately following (week1 and week 2) each treatment session
For assessing CPM, the method examining the influence of the Diffuse Noxious Inhibitory Control system (or spatial summation) on temporal summation (TS) was applied. The experimental pain assessments before and after each treatment were carried out by the same assessor.
次要结局
- the change in Neck Disability Index (NDI)(measured prior to (week 1 and 2) and immediately following (week 1 and 2) each treatment session)
- the change in autonomic activity(week 1 and 2 : measured continuously in real time during CPM and during both treatment sessions)
- the change in scores obtained from the Whiplash Associated Disorders Symptom List(measured prior to (week 1 and 2) and immediately following (week 1 and 2) each treatment session)
研究者
Jo Nijs
Associate professor
Vrije Universiteit Brussel