Randomized Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs for Patients With Chronic Back Pain and Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change in Pain Intensity
研究概览
简要总结
This is a pragmatic, open label, randomized controlled trial with 1:1:1 allocation to 12 weeks of: (1) onsite yoga at opioid treatment programs (OTPs), (2) onsite physical therapy (PT) at OTPs, or (3) treatment as usual (TAU). Participants will be 180 individuals with chronic back pain receiving treatment for opioid use disorder (OUD) in community-based OTPs. Through research visits at screening, baseline, and months 1, 2, 3, 6, and 9, the investigators will evaluate pain and opioid use outcomes and implementation outcomes.
详细描述
This clinical trial will test yoga and physical therapy (PT) for individuals with concurrent opioid use disorder (OUD) and chronic pain (CP), onsite at community-based opioid treatment programs (OTPs). The investigators will focus on those who suffer from back pain, as it is the leading cause of CP among patients with OUD and will recruit individuals who are enrolled in treatment at OTPs in our health system in the Bronx, NY. Lack of integrated treatments addressing both OUD and CP has resulted in failed efforts to control the overdose epidemic. This project addresses this need by proposing to test on-site yoga and PT at OTPs.
The research team's proposed model is that CP from back pain among individuals with OUD leads to decreased physical function, decreased mood and anxiety symptoms, and increased opioid craving. To break this vicious cycle, the investigators propose to target both physical function (via PT or yoga) and mindfulness (via yoga).
Targeting physical function: Both yoga and PT are movement therapies which increase strength and flexibility, improving physical function and pain. Some movement therapies (e.g., exercise) have decreased substance use in individuals with alcohol and tobacco use disorders, but this is understudied in OUD.
Targeting mindfulness: As a mind-body approach, yoga advances overall well-being through practices of mindful breathing and mindfulness meditation. Improving mindfulness may reduce mood and anxiety symptoms, pain catastrophizing, pain intensity and interference, opioid craving and opioid use.
The investigators will test the overall hypothesis that yoga and PT provided onsite at OTPs will improve pain, opioid use, and quality of life among people with OUD and chronic back pain and will be cost effective. The investigators will conduct a hybrid type 1 effectiveness-implementation study, using a pragmatic, open label, three-arm (1:1:1) randomized controlled trial of: a) onsite yoga at OTPs, b) onsite PT at OTPs, and c) treatment as usual (TAU). The investigators will enroll 345 participants (115/115/115) with chronic, moderate or severe back pain in a 12-week intervention. Comprehensive assessments will be done at study enrollment and at months 1, 2, 3, 6, and 9. The investigators will assess pain intensity (primary outcome), pain interference, opioid use and craving, and quality of life.
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
- 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
- •age ≥18 years old
- •English or Spanish proficiency (i.e., be able to participate in study interventions and interviews in English or Spanish)
- •receiving methadone or buprenorphine treatment for OUD in the Montefiore OTP network for at least 12 weeks, with no dose change in 14 days
- •Chronic low or mid back pain, with at least moderate pain severity (score of ≥4 on the Pain, Enjoyment of Life and General Activity (PEG) Scale)
- •Willingness to participate in all study components
- •ability to provide informed consent, assessed using consent teach-back
排除标准
- •severe disabling conditions that could make participation in yoga or PT hazardous (e.g., spinal canal stenosis; severe scoliosis; vertebral fracture, history of spine surgery, or joint surgery in the past six months; severe or progressive neurological deficits, or cardiovascular or neurological disease requiring hospitalization in the past six months; unable to stand for at least 60 seconds; regular use of a wheelchair or motorized scooter, or regular use of a walker and inability to walk at least 4 steps without it; 3 or more falls in the prior year with at least one being non-mechanical;; or other severe disabling conditions deemed by the study clinician or MPI to preclude safe or adequate participation in the study)
- •acute exacerbation of psychiatric conditions that preclude the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis)
- •cancer pain related to malignancy
- •yoga practice or PT in the prior 60 days
研究组 & 干预措施
Yoga
Participants in the yoga group will receive a manualized intervention of 12 weekly, group-based, 60-minute yoga classes, and guided home practice.
干预措施: Yoga (Other)
Physical Therapy
Participants in the PT group will receive a manualized intervention of 12 weekly, individual, 60-minute PT sessions, with home practice, based on the Saper protocol.
干预措施: Physical Therapy (Other)
Treatment As Usual
Participants in the Treatment As Usual group will receive routine clinical care. This includes: 1) pain assessment using a 10-point scale, at OTP admission and annual physical exams. This is documented on a templated form in the OTP electronic health record, as well as whether pain is acute vs chronic pain, and a treatment plan (e.g., on-site care, outside primary care clinician, pain management referral). 2) clinical treatment of pain by participants' on-site or outside clinicians.
干预措施: Treatment As Usual (Other)
结局指标
主要结局
Change in Pain Intensity
时间窗: From Baseline to 1 month, 2 months, 3 months, 6 months, and 9 months
Change in Pain Intensity on average over the prior 7-day period will be assessed using the Brief Pain Inventory (BPI) pain intensity subscale. The BPI pain intensity subscale consists of 4 items which asks patients to rate their worst pain, least pain, average pain, and current pain using a 0-10 numeric rating scale (NRS), where 0 represents "No pain" and 10 represents "Pain as bad as you can imagine" such that higher scores are associated with greater pain intensity. Scores from the four items are averaged to obtain a mean score. Results will be summarized by study arm using basic descriptive statistics.
Illicit opioid use
时间窗: Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months
Illicit opioid use will be a composite outcome defined by self-reported opioid use days over the past 30 days using items from a modified Addiction Severity Index questionnaire. It is defined by the maximum number of days of use of: a) heroin, b) fentanyl \[unprescribed\], and c) prescription opioids \[unprescribed\]. The range of possible days is 0-30. Results will be summarized by study arm using basic descriptive statistics.
次要结局
- Pain Catastrophizing(Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months)
- Opioid Craving(Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months)
- Change in Pain Interference - Brief Pain Inventory (BPI)(From Baseline to 1 month, 2 months, 3 months, 6 months, and 9 months)
- Heroin Use(Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months)
- Fentanyl Use(Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months)
- Unprescribed Prescription Opioid Analgesic Use(Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months)
- Health-related quality of life (HRQoL)(Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months)
- Physical Activity - International Physical Activity Questionnaire Short Form (IPAQ-SF)(Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months)
- Retention in Medications for Opioid Use Disorder (MOUD)(Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months)
- Global Impression of Change(1 month, 2 months, 3 months, and 9 months)
- Depressive Symptoms(Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months)
- Anxiety Symptoms(Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months)
- Positive urine test for non-prescribed opioids(Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months)
- Physical Function Assessments - Fingertip-to-floor test(Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months)
- Physical Function Tests - Short Physical Performance Battery (SPPB)(Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months)
- Physical Function, self-reported(Baseline (Week 0), 3 months, 6 months, and 9 months)
- Back Pain-related Disability(Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months)
- Fear Avoidance(Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months)
- Mindfulness(Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months)
- Intervention Session Attendance(3 months)