Establishing the Effectiveness of BBTI vs. PSR on Sleep and Pain Parameters in Adults With Musculoskeletal Orofacial Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in Self-report Quality of Life
研究概览
简要总结
This clinical study aims to compare the efficacy of two brief psychological interventions: Brief Behavioral Therapy for Insomnia (BBIT) and Physical Self-Regulation or (PSR) delivered over telehealth for the management of chronic musculoskeletal orofacial pain conditions (local myalgia, myofascial pain, centrally mediated myalgia) in a tertiary orofacial pain clinic. It is hypothesized that both interventions will produce beneficial changes and exploratory analysis will aim to establish which intervention -if any- is better for each specific outcome.
详细描述
New patients who come into the orofacial pain clinic are evaluated by a dental resident and given an orofacial pain diagnosis. If this primary diagnosis involves masticatory myofascial pain, local myalgia, or centrally-mediated myalgia, and if patients self-report poor sleep, they will be introduced to the study. An initial evaluation for PSR and BBTI will be scheduled over telehealth. If willing and eligible to participate, at the end of this first evaluation, they will be provided with an informed consent form and be randomly assigned to three sessions of PSR or three sessions of BBTI. After providing an e-consent, they will be sent a questionnaire battery on REDCap to assess their outcomes at pre-intervention. A REDCap daily questionnaire will be sent every day (morning and evening) starting one week before session 1 of the intervention, until two weeks after the last session. Moreover, to a small group of patients randomly selected, an actigraphy watch will be mailed. Two weeks after the last session of the intervention, a REDCap questionnaire will be sent to assess their outcomes at post-intervention. As per the current clinical protocol, all participants will be offered both interventions; only data from the first intervention will be utilized for the current study. All PSR and BBTI sessions will be conducted via telehealth using a HIPAA-compliant zoom account.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Data will be coded such that the Principal Investigator (PI) analyzing the data will be blind to conditions to prevent bias during the data collection and analysis. Also, the PI will remain blind through the study and will not provide either of the interventions. The statistician will be blind. The examiner will collect the data after de-identification of the sensitive and identifiable data.
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
- •present with a score on Insomnia Severity Index > 15
- •have a primary diagnosis of chronic (onset more than 3 months before) MSK pain (myofascial pain and/or local myalgia and/or centrally mediated myalgia) from a board-certified orofacial pain specialist at UK Orofacial Pain Clinic
- •maintain a stable medication regime in previous month and during the intervention
- •older than 18 years old
- •able to understand English
- •willing to participate to telehealth intervention
- •have internet access and an email address
- •present with total STOP BANG score < 5
排除标准
- •less than 18 years old
- •unable to provide informed consent
研究组 & 干预措施
Brief Behavioral Therapy for Insomnia, BBTI
Participants in this group will receive 3 sessions of BBTI over telehealth.
干预措施: Brief Behavioral Therapy for Insomnia, BBTI (Behavioral)
Physical Self-Regulation, PSR
Participants in this group will receive 3 sessions of PSR over telehealth.
干预措施: Physical Self-Regulation, PSR (Behavioral)
结局指标
主要结局
Change in Self-report Quality of Life
时间窗: At pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention)
The overall quality of life will be assessed with 12-Item Short Form Health Survey (SF-12), a 12-item questionnaire designed to measure general health by addressing eight domains: limitations in social, physical, usual role activities because of physical health and emotional problems; bodily pain; general mental health; vitality; general health perceptions. SF-12 has been shown to reflect change over time like the long form SF-36 and to demonstrate good reliability and validity . Studies have addressed the impact of orofacial pain and sleep problems on health-related quality of life. The average score of the US population is set at 50. A score below this cut-off identifies a poor self-report quality of life.
Change in Self-report Insomnia Symptoms
时间窗: At pre-intervention (1 week before starting with the intervention) and post-intervention (2 weeks after the last session of the intervention)
Insomnia symptomatology will be assessed via the Insomnia Severity Index (ISI). The ISI includes seven items (sleep-onset, sleep maintenance, early morning awakening, satisfaction with current sleep pattern, interference with daily functioning, impairment attributed to sleep problems, distress caused by sleep problems), related to the prior 2 weeks on a five-point Likers scale (0= no problem, 4 = severe problem). The total score ranges from 0 to 28, with 28 indicating severe insomnia. The cut-off for the present study is 15. The ISI has good internal consistency and is demonstrated to be sensitive to changes in sleep of older adults following behavioral treatment for insomnia. Clinical improvement is defined as a reduction of ISI below the cut-off of 15.
Change in Self-report Average Pain Intensity
时间窗: At pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention)
The average pain intensity will be assessed using a Numeric Rating Scale (NRS) on a 10-point scale, where 0 coincides with "no pain" and 10 coincides with "worse pain ever felt".
次要结局
- Change in Self-report Sleep Quality(At pre-intervention (1 week before starting with the intervention), post-intervention (2 weeks after the last session of the intervention))
- Sleep architecture(Each morning and each evening from the first session to 2 weeks after the last session of the intervention)
- Change in Self-report Anxiety Symptoms(At pre-intervention (one week before the first session of the intervention), at post-intervention (two weeks after the last session of the intervention) and every day during the intervention period)
- Change in Self-report Depression Symptoms(At pre-intervention (one week before the first session of the intervention), at post-intervention (two weeks after the last session of the intervention) and every day during the intervention period)
- Change in Self-report Headache Intensity(At pre-intervention (one week before the first session of the intervention), at post-intervention (two weeks after the last session of the intervention))
- Change in Self-report Headache Frequency(At pre-intervention (one week before the first session of the intervention), at post-intervention (two weeks after the last session of the intervention))
研究者
Ian Boggero, PhD
Assistant Professor
University of Kentucky