Open-label Placebo in Manual Therapies: a Pilot Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in Numeric Rating Scale
研究概览
简要总结
to investigate the effects of placebo in patients affected by low-back pain.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (+18 years) who complain of chronic non-specific low back pain for at least 3 months with or without pain exacerbations at the time of recruitment, will be included.
- •Patients will need to have a diagnosis of low back pain made by a physician
排除标准
- •pathologies such as ankylosing spondylitis, infections, fractures, tumors or metastases.
- •Pregnant women
- •patients with previous spinal surgery or undergoing cortisone therapy in the 6 months prior to the trial
- •diseases that may affect the interpretation of results such as fibromyalgia
- •patients currently being treated by other specialists or other manual therapists
研究组 & 干预措施
OMT
Participants will receive manual treatments. The treatment will include soft-tissue, joint mobilization techniques of the lumbar and sacral region. The treatment will also include the approach of the abdomen and lower limb with the same type of techniques.
Four treatments will be provided at 1, 2, 4 and 8 weeks.
干预措施: Osteopathic manipulative treatment (Other)
Waiting list
Participants will receive no treatment.
Open-label placebo
This group will receive an open-label placebo. The manual treatment will be performed in the same areas of the active comparator but using a very light pressure. Additionally, before the start of the treatment, Four treatments will be provided at 1, 2, 4 and 8 weeks.
干预措施: Open-label placebo (Other)
结局指标
主要结局
Change in Numeric Rating Scale
时间窗: Change from baseline of numeric rating scale at week 2, 4 and 8.
a verbal determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain.
Adverse effects
时间窗: through study completion (8 weeks)
Number and types of adverse effects occurred after intervention
次要结局
- Changes in algometer measurements(from baseline at week 2, 4 and 8)
- Change in measures of Von Frey filaments(from baseline at week 2,4 and 8.)
- Changes in algometer measurements(from baseline at week 2, 4 and 8)
- Use of analgesics(The week before the scheduled visit.)
研究者
Carolina Lavazza
Principal investigator
Studio Osteopatico Busto Arsizio