Effects of Craniosacral Therapy on Chronic Neck Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
The purpose of this randomized controlled trial is to determinate the efficacy and safety of Craniosacral Therapy in the treatment of chronic unspecific neck pain.
详细描述
Craniosacral Therapy (CST) is a variation of osteopathic manipulation with an integrative approach. By soft manual palpation of the craniosacral and fascia system sensory, motor, cognitive, and emotional processes can be influenced. In the prevention and treatment of chronic pain syndromes Craniosacral Therapy is demonstrated to be effective in clinical practice and quite a few scientific trials. But yet there are no randomized controlled studies concerning to chronic neck pain. So the aim of this study is to investigate whether a total of 8 CST units of 45 minutes will be effective in patients suffering from chronic nonspecific neck pain in contrast to sham therapy of the same extent. The prospective study design includes measurement points at baseline, post treatment, and 3 months follow-up.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic unspecific neck pain for at least 3 months
- •Mean neck pain of moderate intensity (>/=45mm on VAS)
- •Therapy-naive subjects
排除标准
- •Specific neck pain due to severe deformity of the spine, prolapse, rheumatic or neurological disorder, trauma, operation or cancer
- •other severe somatic or psychiatric comorbidity
- •pregnancy
- •regular intake of opiates, corticosteroids (>10mg prednisolon), muscle relaxants or antidepressants
- •recent invasive or manipulative treatment of the spine
- •participation in other clinical trials
研究组 & 干预措施
Craniosacral Therapy (CST)
Each participant of the experimental group receives 8 Craniosacral Therapy units once a week of 45 minutes.
干预措施: Craniosacral Therapy (Procedure)
Sham Craniosacral Therapy (SHAM)
Each participant of the sham group receives 8 sham therapy units once a week of 45 minutes.
干预措施: Sham Craniosacral Therapy (Procedure)
结局指标
主要结局
Pain intensity
时间窗: week 8
Pain intensity on a 100mm visual analogue scale (VAS)
次要结局
- Pain intensity in motion(week 8)
- Pain acceptance(week 8)
- Disability(week 8)
- Quality of life(week 8)
- Global Impression(week 8)
- Safety(week 8)
- Pressure pain threshold(week 8)
- Anxiety and depression(week 8)
- Stress perception(week 8)
- Well being(week 8)
- Body awareness(week 8)
研究者
Heidemarie Haller
Postdoctoral Research Fellow
Universität Duisburg-Essen