Evaluation of the Effects of the Association of the Osteopathic Manipulative Treatment to Exercises, Education for Pain in Participants With Cervical Pain - Pragmatic Clinical Trial Randomized
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
The purpose of this randomized pragmatic clinical trial is to assess the effectiveness of the association of the osteopathic manipulative treatment in individuals with chronic non-specific neck pain who receive a exercice program and pain neurocience education.
详细描述
The purpose of this study is to determine whether osteopathic manipulative treatment associated exercises and pain neurocience education improves pain and function in individuals with chronic non-specific neck pain
Design: a randomized single blind controlled pragmatic trial will be conducted trial. Patients (n=40) with non-specific neck pain will be randomized to receive 1) osteopathic manipulative treatment and exercise and and pain neurocience education (n=20) or 2) exercise alone and pain neurocience education (n=20). Participants will receive 8 treatments during 4 weeks. Clinical outcomes will be obtained at 1 week, four weeks and 24 weeks after end of treatment.
Methods:
The primary outcome will be pain measured by 11-point numerical pain rating scale. The secondary outcome will be disability measured by the Neck Disability Index, range of motion measured by Cervical Range of Motion device, Pressure pain threshold measured by electronic algometer, global perceived effect, Pain Self-Efficacy Questionnaire and pain catastrophizing scale
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms of chronic neck pain does not specify that persists for more than 3 months
- •Pain at least 3 points on 0-10 numeric pain rating and at least 14% disability on Neck Disability Index
排除标准
- •individuals who report inflammatory previous surgery, spondylolisthesis, spinal stenosis, herniated disc, radiculopathy, fracture and musculoskeletal degenerative diseases. , Cancer, neurological diseases, pregnancy. They will be excluded participants who received some form of manipulative treatment in the last three months.
结局指标
主要结局
Pain intensity
时间窗: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
measured by numeric rating scale
次要结局
- Functionality and disability(Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment)
- Self-efficacy(Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment)
- Range of motion(Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment)
- Pressure pain threshold(Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment)
- kinesiophobia(Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment)
- Global perceived effect(Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment)
- Catastrophizing(Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment)
- McGuill(Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment)
研究者
Sandro Groisman, PT, DO, MSc
Master
Instituto Brasileiro de Osteopatia