Effects of Dry Needling and Therapeutic Exercise on Sleep in Individuals With Chronic Neck Pain and Sleep Disturbance - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Participant retention rate
研究概览
简要总结
Feasibility study investigating the effects of dry needling on individuals with chronic neck pain and sleep disturbance.
详细描述
The purpose of this pilot study is to determine the feasibility of a large randomized clinical trial (RCT) which aims to investigate the effects of dry needling (DN) in addition to therapeutic exercise (TE) on sleep duration and quality in patients with chronic neck pain (CNP) and sleep disturbance (SD). Specifically, the objective is to explore feasibility of a study protocol and examine the preliminary data of a small sample size for the effectiveness of DN and TE for individuals with CNP and SD to determine effect size of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to group assignment of participants.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neck pain lasting greater than 3 months 28,29
- •Age: 18-75 years
- •Presence of sleep disturbance - to be defined as a score ≥ 8 on the Insomnia Severity Index
- •Ability to understand study procedures and to comply with them for the entire length of the study
排除标准
- •Previous surgery to the neck or thoracic spine
- •Central nervous system disorders
- •Systemic joint disease (e.g. rheumatoid arthritis)
- •Infection
- •Raynaud's disease
- •Pregnancy
- •Immunocompromised disease (e.g., diabetes mellitus, HIV, AIDS, lupus)
- •Insufficient English-language skills to complete all questionnaires.
- •Contraindications to dry needling:
- •Presence of needle phobia
- •History of abnormal reaction to needling or injection
- •History of bleeding disorder (e.g., current anticoagulant therapy or known thrombocytopenia)
研究组 & 干预措施
Dry Needling and Therapeutic Exercise
干预措施: Dry Needling (Procedure)
Dry Needling and Therapeutic Exercise
干预措施: Therapeutic Exercise (Other)
Therapeutic Exercise Alone
干预措施: Therapeutic Exercise (Other)
结局指标
主要结局
Participant retention rate
时间窗: 1 year
One variable to be assessed to determine feasibility is retention rate of participants recruited and enrolled. The retention rate of participants will be calculated as follows: Retention rate = (Number of patients completing the study / Number of patients initially enrolled) x 100. Feasibility will be determined with 4-week attrition rate is less than 20%
Participant intervention adherence
时间窗: 1 year
One variable to be assessed to determine feasibility is intervention adherence. Adherence to therapeutic exercise program given to all participants will be assessed with an exercise diary to be completed by the participants to track exercise compliance. A new diary will be provided on a weekly basis to maintenance of records.
Number of adverse responses to treatment
时间窗: 1 year
Occurrence of adverse responses to treatment will be accounted for at each subsequent visit after initial treatment administered (visits 3-6). Patients will be asked to complete an intake form that will inquire about their experience post-intervention and provide examples of common adverse responses to determine if such events occurred for each respective participant.
次要结局
- Sleep Duration(5 weeks)
- Sleep Quality(13 weeks)
研究者
Ray M. Lunasin
Principal Investigator
Mayo Clinic