Clinical and Biological Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Feasibility
研究概览
简要总结
The purpose of this pilot project is to determine the feasibility of a study design to investigate how many sessions of manual therapy and exercise produce the best results for people with whiplash injuries. Also, this study will help us determine the best way to measure the effect of treatment. Finally, the investigators will study how closely the physiotherapists follow the treatment instruction provided in the study protocol and training. In order to achieve these objectives, 12 people will receive manual therapy and exercise at one of twelve different doses. the investigators will have each of these people fill out questionnaires, measure sensation changes, and measure changes in the way people move their necks while walking. This study will help us determine if the study protocol can be carried out as planned. This includes: the training of all people involved in carrying out the assessments and treatments, the willingness and ability of participants to take part in all of the treatment and measures involved. This will provide us with important information to help us plan a larger study with 226 people with whiplash injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults ≥ 21 years
- •main complaint must be neck pain, but we expect some patients will also report symptoms that radiate to the shoulder and arm regions or have an associated headache.
- •pain intensity must be ≥ 12/40 on the 4-item pain scale (P4).
排除标准
- •non-mechanical sources of neck pain or over-riding comorbidity listed below:
- •rheumatoid arthritis
- •neurological diseases
- •fractures
- •dislocation
- •rheumatoid arthritis
- •upper motor neuron dysfunction or malignancy
- •pregnant women
- •closed head injury
- •on steroid-based medications within the past 6 months.
结局指标
主要结局
Feasibility
时间窗: 1 year
As a pilot study, the main outcome of interest is feasibility. This includes: ability to train assessors and health care providers, time it takes to complete all assessments, ability to recruit 12 patients within 1 year, and completeness of data collected.
Pain
时间窗: 12 weeks (end of treatment) and 6- and 12- month follow-ups
Measured by the 4-item pain questionnaire (P4). This will be a primary outcome of the full trial.
Function
时间窗: 12 weeks (end of treatment) and 6- and 12- month follow-up
Measured by the Neck Disability Index (NDI). This will be a primary outcome measure of the full powered study.
次要结局
- Fidelity(1 year)
- Psychological measures(12 weeks (end of treatment))
- Psychophysical measures(12 weeks (end of treatment))
- Upper extremity function(12 weeks (end of treatment) and 6- and 12-month follow-ups)
- Motor coordination(12 weeks (end of treatment))
- Health Status(12 weeks (end of study) and 6- and 12- month follow-ups)
- Global perceived effect(12 weeks (end of treatment) and 6- and 12-month follow-ups)
研究者
Jordan Miller, Graduate Student
Graduate student, School of Rehabilitation Science
McMaster University