The METRIC Study Protocol: an Explanatory Randomized Controlled Trial Investigating the Neurophysiological Mechanisms Underlying the Therapeutic Effects of Spinal Manipulative Therapy for Chronic Primary Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- low back pain intensity
研究概览
简要总结
The goal of this clinical trial is to test the effects of spinal manipulative therapy in individuals with chronic primary low back pain and determine the neurophysiological mechanisms underlying pain relief. The main questions it aims to answer are: • Is pain relief produced by spinal manipulative therapy in patients with chronic primary low back pain caused by a reduction of C-fiber-related nociceptive processing? • Are these effects greater when spinal manipulative therapy is applied to the whole spine where it is clinically indicated compared with lumbar spine only? • Are these effects greater after 36 treatments over 3 months compared with 12 treatments over 1 month. Participants will receive spinal manipulative therapy (all clinically indicated spine segments or back only) or a control intervention. A group of healthy volunteers will be recruited to assess secondary outcome measures over the same time period, as reference data for comparisons. Researchers will compare the two groups receiving spinal manipulative therapy to the group receiving the control intervention to see if clinical pain relief and the reduction of temporal summation of second pain (produced experimentally) is significantly greater with spinal manipulative therapy.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Duration of current low back pain (LBP) episode ≥ 6 months;
- •Average LBP intensity during the last 7 days ≥ 3/10;
- •(For healthy volunteers only) To be of the same sex and age (± 1 year) as a participant with low back pain.
排除标准
- •Diagnosis of back conditions other than chronic primary LBP e.g., failed back surgery syndrome, spondylosis, spondylolisthesis, spinal stenosis, herniated disc, infection, etc.;
- •Presence of pain in another body location that is more severe than the pain in the lower back;
- •Presence of a neurological deficit i.e., sensation loss, muscle weakness, decreased deep tendon reflexes;
- •Presence of contraindications to spinal manipulative therapy e.g., recent fracture, history of spinal surgery, cauda equina syndrome, inflammatory arthritis, taking anticoagulant medication, active cancer, moderate to severe osteoporosis, abdominal aortic aneurysm;
- •Underwent surgery in the last 3 months;
- •Pregnancy, ≤ 3 months post-partum or planning to get pregnant in the next 12 months;
- •History of spinal manipulative therapy in the past 12 months;
- •Scoliosis ≥ 20°;
- •BMI ≥ 40;
- •Insufficient language skills in French to complete the questionnaires;
- •Open or pending litigation for LBP or seeking/receiving disability compensation;
- •Diagnosis of an illness affecting the sensorimotor functions e.g., diabetes, multiple sclerosis, amyotrophic lateral sclerosis;
- •Diagnosis of mental health disorders (with the exception of anxiety and depression);
- •Current drug or alcohol dependence;
- •Skin of type I on the Fitzpatrick scale;
- •(For healthy volunteers only) Regular use of pain medication or usage in the 48 h prior to data collection;
- •(For healthy volunteers only) History of chronic pain;
- •(For healthy volunteers only) Acute pain on the days of data collection.
结局指标
主要结局
low back pain intensity
时间窗: baseline, 1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.
In accordance with recommendations for chronic pain trials, participants will be instructed to rate the intensity of their LBP using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). As in the brief pain inventory (BPI), they will be instructed to rate their pain: 1) right now; 2) on average over the last 7 days; 3) at its worst over the last 7 days; 4) at its best over the last 7 days.
temporal summation of second pain
时间窗: baseline, 4- and 12-weeks post-randomization.
Participants will receive a total of 160 painful laser stimuli, 80 single-pulse stimuli and 80 pulse trains (3 pulses delivered at 0.67 Hz). After each stimulus, participants will be prompted to rate second pain with the display of a numerical pain rating scale. The pain ratings of single pulses will be subtracted from the pain ratings of pulse trains to estimate the intensity of the temporal summation of second pain.
次要结局
- Pressure pain thresholds (PPTs)(baseline, 4- and 12-weeks post-randomization.)
- low back pain frequency and duration(baseline, 1- , 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-, 11-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.)
- C-fiber-related brain responses(baseline, 4- and 12-weeks post-randomization.)
- Five times sit-to-stand test(baseline, 4- and 12-weeks post-randomization.)
- Pain catastrophizing(baseline, 4- and 12-weeks post-randomization.)
- Oswestry Disability Index (ODI)(baseline, 4-, 12-, 26-, 39-, 52- and 64-weeks post-randomization.)
- Back performance scale (BPS)(baseline, 4- and 12-weeks post-randomization.)
- Anxiety(baseline, 4- and 12-weeks post-randomization.)
- Patient's global impression of change(After the last treatment session (12-weeks post-randomization))
- Contextual factors (healing encounters and attitudes lists (HEAL))(baseline, 4- and 12-weeks post-randomization.)
- Depression(baseline, 4- and 12-weeks post-randomization.)
- Kinesiophobia(baseline, 4- and 12-weeks post-randomization.)
- Pain vigilance(baseline, 4- and 12-weeks post-randomization.)
- Expectations of pain relief(baseline and 4-weeks post-randomization.)
研究者
Mathieu Piché
Professor
Université du Québec à Trois-Rivières