Is the Subjective Experience of Recovery From Low Back Pain Related a Decrease in the Sensitivity of Pain Mechanisms?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Temporal summation of pain (increase in pain from repeated nociceptive stimuli at the same intensity) measured with a computer-controlled pressure cuff
研究概览
简要总结
Several cross-sectional studies have demonstrated that patients with chronic low back pain have higher levels of pain sensitivity (local and widespread) when compared to controls. It is unclear however, if improvements in pain and function are reflected in a decrease in the sensitivity of pain mechanisms. This study compares the pain sensory profile in patients with chronic low back pain before and after a period of physiotherapy treatment. To account for natural fluctuations in pain sensitivity, healthy age matched controls are also measured twice
详细描述
The sensitivity of pain mechanisms has consistently been shown to be increased in people suffering from chronic low back pain. This includes both sensitivity in the painful region but also in areas distant indicating widespread pain sensitivity. It is less clear whether this is normalized following a successful treatment intervention.
This study is recruiting people with low back pain and healthy, age matched controls. At baseline, the following measurements are made:
- the sensitivity to pressure (at the low back and at the shoulder)
- the pain detection threshold and pain tolerance threshold at the lower legs
- the temporal summation of pain
- conditioned pain modulation
- Fear-avoidance beliefs
- Disability (Roland-Morris Disability Questionnaire)
- The Orebro musculoskeletal pain questionnaire
During their enrollment, the patients report their weekly pain electronically
All quantitative sensory testing (QST) and questionnaire data are blind to the principal investigator until data collection has been finished
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient group
- •Pain located in the low back region, defined as the area lying between the posterior superior iliac spine below and the thoracolumbar junction above
- •The pain has lasted between 3 and 60 months
排除标准
- •Pain related to a specific pathology such as spinal stenosis, metastasis, fracture etc.
- •Leg pain related to nerve root compression/irritation.
- •Multiple painful sites/areas unrelated to the back pain
- •Operation to the spine
- •Any neurological or systemic diseases which can affect the outcome measures
- •Pregnancy
- •Lack of ability to cooperate
- •Control group Inclusion Criteria
- •Are healthy and free from any pain specific to the low back and/or in general
- •Exclusion Criteria
- •No current or previous history of on-going pain, defined as pain lasting more than 3 months, in the lumbopelvic region and/or elsewhere
- •Have participated in studies using a similar experimental pain model
结局指标
主要结局
Temporal summation of pain (increase in pain from repeated nociceptive stimuli at the same intensity) measured with a computer-controlled pressure cuff
时间窗: At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls)
Change in temporal summation of pain between baseline and follow-up. Temporal summation of pain is assessed by using a computer controlled pressure cuff which is mounted on the lower leg on the dominant side. The participant receives 10 stimuli with a 1sec break between stimuli. Immediately following each stimuli, the participants rates the pain intensity using an electronic VAS scale (0-10, where 0=no pain and 10=worst pain imaginable)
Sensitivity to mechanical point pressure measured with a handheld pressure algometer
时间窗: At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls)
Change in sensitivity to mechanical point pressure back (L5 and L1) and shoulder (infraspinatus) between baseline and discharge from rehabilitation. Mechanical point pressure is measured with a handheld pressure algometer (Somedic, Sweden). The average from dominant and non-dominant sides will be used for analysis
Conditioned pain modulation (change in pain sensitivity following the onset of a competing, nociceptive stimulus) measured with a computer-controlled pressure cuff
时间窗: At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls)
Change in conditioned pain modulation between baseline and follow-up. Conditioned pain modulation is assessed by using two computer controlled pressure cuffs which are mounted on the lower legs, one on each side. On the non-dominant side, the cuff is inflated rapidly up to 80% of the pain tolerance threshold and kept there steady. In the meanwhile, the pain detection threshold and pain tolerance thresholds are assessed on the dominant side. Changes in PDT and PTT compared with baseline are defined as a CPM response.
Change in cuff-pressure mechanical sensitivity, measured with a computer-controlled pressure cuff
时间窗: At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls)
The pressure needed to evoke first onset of pain (pain detection threshold, PDT) and the most pressure tolerable (pain tolerance threshold, PTT) are measured with a computer controlled pressure cuff. The cuff is placed on the lower leg and is gradually inflated (1kPa/sec). The first onset of pain (VAS 1, measured on an electronic VAS scale: 0=no pain, 10=worst pain imaginable) is indicated when the sensation of pressure around the leg changes to pain. The pressure continues to rise until the PTT is reached. PTT is defined as the point where the subject cannot endure more increase in pressure.
次要结局
- Pain (measured on a numeric rating scale)(At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls))
- Disability measured on the Roland-Morris Disability Questionnaire(At baseline and after discharge from treatment (patients) or after 6-8 weeks (controls))
研究者
Thorvaldur Skuli Palsson
Assistant professor
Aalborg University