Acupuncture for Headache Post-Traumatic Brain Injury: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Proportion of weekly acupuncture sessions completed over 12 consecutive weeks
研究概览
简要总结
This study evaluates and addresses challenges to implementing an acupuncture intervention for adults who have headaches after sustaining a moderate traumatic brain injury. Eligible participants will be recruited from Seattle and the surrounding areas to receive weekly acupuncture for 12 consecutive weeks. Participants will complete questionnaires to assess headache impact, depression, health-related quality of life, and cognitive function at the beginning of the study and every two weeks for the duration of the study. Participants will participate in structured interviews after the study for their views on the acceptability and tolerability of the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Has a history of moderate traumatic brain injury (TBI) one to five years previously
- •Currently under medical supervision for post-traumatic headache
- •Have a score ≥ 3 on the Patient Health Questionnaire 2
- •Have a raw summed score ≤ 6 on the PROMIS Cognitive Function Short Form v2.0 - Abilities 2a (part of PROMIS-29+2 Profile)
- •Community-dwelling
- •18 years of age and older
- •English Speaking
- •Able to provide voluntarily consent
排除标准
- •History of multiple TBIs
- •History of receiving acupuncture treatment in the past six months for the primary condition of headache
- •An established diagnosis of PTSD
- •Psychosis or agitation
- •Other neurodegenerative disorders
- •Other medical/surgical condition that precludes travel to participate in the intervention over the study duration
- •Has an active skin lesion or acute trauma over or around the proposed acupuncture points
- •History of trauma to the head that currently prevents the use of acupuncture points along the midline of the scalp
- •Persons who are pregnant
- •Unable to provide informed consent for the research as identified as answering more than two incorrect responses on the Six-item Screener
研究组 & 干预措施
Acupuncture
干预措施: Acupuncture (Other)
结局指标
主要结局
Proportion of weekly acupuncture sessions completed over 12 consecutive weeks
时间窗: 12 weeks
Retention rate will be evaluated by the proportion of weekly acupuncture sessions completed per participant over the course of 12 consecutive weeks.
Proportion of survey questionnaires completed
时间窗: 12 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Data completeness in survey questionnaires
时间窗: 12 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
Participants' perceptions of feasibility of the study with structured interviews
时间窗: After 12 weeks, or within two weeks of withdrawal from the study
After 12 weeks in the study, participants will participate in structured interviews for their views on the acceptability and tolerability of the study protocol and acupuncture protocol, recommendations for recruitment and retention, and experiences during the intervention. Interviews with participants withdrawn from the study will be attempted within two weeks of the withdrawal.
Proportion of survey questionnaires completed
时间窗: 6 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
时间窗: Baseline
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
时间窗: 2 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
时间窗: 4 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
时间窗: 8 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Proportion of survey questionnaires completed
时间窗: 10 weeks
Respondent burden will be evaluated by the proportion of survey questionnaires completed.
Data completeness in survey questionnaires
时间窗: Baseline
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
时间窗: 2 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
时间窗: 4 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
时间窗: 6 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
时间窗: 8 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
Data completeness in survey questionnaires
时间窗: 10 weeks
Data completeness in survey questionnaires will be evaluated during data collection.
次要结局
- Self-reported changes in medication dose(Baseline, 12 weeks)
- Headache Impact Test - 6(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks)
- Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks)
- PROMIS Short Form v1.0 - Anxiety 4a(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks)
- PROMIS Short Form v2.0 - Physical Function 4a(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks)
- PROMIS Short Form v1.0 - Pain Interference 4a(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks)
- PROMIS Short Form v1.0 - Fatigue 4a(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks)
- PROMIS Short Form v1.0 - Sleep Disturbance 4a(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks)
- PROMIS Short Form v1.0 - Ability to Participate in Social Roles and Activities 4a(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks)
- PROMIS Short Form v2.0 - Cognitive Function 4a(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks)
- PROMIS Pain Intensity Item (Global07)(Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks)
研究者
Mark Sodders
Post Doctoral Scholar, Principal Investigator
University of Washington