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.
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. Aim 1. To test the effectiveness of onsite yoga at OTPs in patients with OUD and CP at 6 months follow-up. H1a: Compared to TAU, on-site yoga will result in decreased pain intensity (primary pain outcome), pain interference, and illicit opioid use in the past 30 days (primary OUD outcome), and increased quality of life. H1b: Therapeutic improvement in H1a will be mediated by physical function and mindfulness. Aim 2. To test the effectiveness of onsite PT at OTPs in patients with OUD and CP at 6 months follow-up. H2a: Compared to TAU, onsite PT will result in decreased pain intensity (primary pain outcome), pain interference, and illicit opioid use in the past 30 days (primary OUD outcome), and increased quality of life. H2b: Therapeutic improvement in H2a will be mediated by physical function. Aim 3. To inform future implementation and dissemination efforts: 3a) Examine factors influencing Reach, Adoption, Implementation, and Maintenance (RE-AIM outcomes) of onsite yoga and PT at OTPs. The investigators will use qualitative and quantitative methods to describe multi-level factors influencing these domains, including qualitative interviews with 30 participants and 10 OTP stakeholders. Exploratory Aim. The investigators will also explore the effectiveness of yoga compared to PT on outcomes and will examine complex patterns of predictors of pain and OUD outcomes with respect to each intervention, including alcohol and cannabis use, mood and anxiety symptoms, comorbidities, and social determinants of health.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Each yoga class will follow a standardized structure, allowing participants to easily re-join if they miss classes. Yoga classes will be adapted to the abilities and limitations of each study participant, for example, using a chair for sitting exercises rather than the floor and to assist with balance. Postures (asanas) will target back pain and include mindfulness, relaxation, and breathing practices integral to hatha yoga, with focus on breath-based movement throughout. Each group will have 1-2 yoga instructors and no more than 5 participants per yoga instructor (up to 10 participants/group).
The assessment at the second screening visit by the Physical Medicine \& Rehabilitation physician/Physical Therapy staff will be available to physical therapists in the Electronic Health Record and will guide the type of exercises, to focus on stabilization (strengthening core trunk muscles) and flexion or extension exercises. Sessions are divided into 30 minutes of working directly with a physical therapist and 30 minutes of supervised aerobic exercise (on treadmill or recumbent bike). Participants will receive a guidebook for guiding and recording home practice, based on Saper's guidebook and modified based on feedback from experts and stakeholders for clarity and cultural appropriateness.
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. Those patients who receive on-site medical care have the opportunity to address nonpharmacological and pharmacological treatment with onsite physicians and physician assistants, and to receive referral to specialty care including physical therapy and orthopedics at multiple Montefiore locations throughout the Bronx.
Montefiore DoSA Wellness Centers
The Bronx, New York, United States
Change in Pain Intensity
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.
Time frame: From Baseline to 1 month, 2 months, 3 months, 6 months, and 9 months
Illicit opioid use
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.
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months
Change in Pain Interference - Brief Pain Inventory (BPI)
Change in Pain interference on average over the prior 7-day period will be assessed using the Brief Pain Inventory (BPI) pain interference subscale. The BPI pain interference subscale consists of 7 items which asks patients to rate how much pain has interfered with mood, walking ability, work, relations with others, sleep, enjoyment of life, and general activity using a 0-10 numeric rating scale (NRS), where 0 represents "Does not interfere" and 10 represents "Completely interferes" such that higher scores are associated with greater pain interference. Scores from the seven items are averaged to obtain a mean score. Results will be summarized by study arm using basic descriptive statistics.
Time frame: From Baseline to 1 month, 2 months, 3 months, 6 months, and 9 months
Heroin Use
Heroin use will be defined by self-reported heroin use days over the past 30 days using an item from a modified Addiction Severity Index questionnaire. The range of possible days is 0-30. Results will be summarized by study arm using basic descriptive statistics.
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months
Fentanyl Use
Fentanyl use will be defined by self-reported, unprescribed, fentanyl use days over the past 30 days using an item from a modified Addiction Severity Index questionnaire. The range of possible days is 0-30. Results will be summarized by study arm using basic descriptive statistics.
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months
Unprescribed Prescription Opioid Analgesic Use
Unprescribed prescription opioid analgesic use will be defined by self-reported number of days of prescription opioid analgesic use that is not prescribed, over the past 30 days, using items from a modified Addiction Severity Index questionnaire. The range of possible days is 0-30. Results will be summarized by study arm using basic descriptive statistics.
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, and 9 months
Health-related quality of life (HRQoL)
HRQoL will be assessed using a utility score from the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) scoring system. PROPr summarizes several PROMIS domains into a single, preference-based score. PROPr is a health utility score which aggregates scores from 7 PROMIS domains: Cognitive Function/Abilities, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. PROPr scores are calculated using a multiplicative multiattribute utility function that combines the individual PROMIS domain scores into a single score. The PROPr score is expressed as a health utility index value on a scale between 0 (the utility of being dead) and 1 (utility of full health) such that higher scores are indicative of better perceived overall health utility. Scores will be summarized by study arm using basic descriptive statistics.
Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months
Pain Catastrophizing
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS) short form. The PCS short form is a 6-item scale which examines the subscales of rumination, magnification, and helplessness related to pain. The six items on the PCS short form are rated on a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("All the time") yielding an overall possible score of 0-24 such that higher scores are indicative of a greater degree of pain catastrophizing. Scores will be summarized by study arm using basic descriptive statistics.
Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months
Opioid Craving
Opioid craving will be assessed using the Opioid Medication Craving Scale. The Opioid Medication Craving Scale is a 3-item form in which participants are asked to provide responses on a 100 point scale as to how strong their desire to use opioids was over the past 24 hours; the likelihood they would use opioids if placed in the same environment of previous use; and how strong urges are for opioids when something in the environment reminds them of it. The 1st and 3rd items are rated on a scale from 0 ("No Desire") to 100 ("Strong Desire"). The 2nd item is rated on a scale from 0 ("No likelihood of use") to 100 ("Strong likelihood of use"). An overall score is obtained by averaging the three ratings with higher scores being associated with more intense cravings. Results will be summarized by study arm using basic descriptive statistics.
Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, 6 months and 9 months
Physical Activity - International Physical Activity Questionnaire Short Form (IPAQ-SF)
Physical Activity will be assessed using the IPAQ-SF. The IPAQ consists of four items which query as to the number of days in which four types of activities were performed over the past 7 days: vigorous activity, moderate activity, walking, and sedentary activity. Participants respond as to the number of days per week spent on each type or category of physical activity described. The number of days of physical activity will be categorically summarized by study arm using basic descriptive statistics.
Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months
Global Impression of Change
Global Impression of change from the beginning of the study will be evaluated using the Patient Global Impression of Change (PGIC) assessment. The PGIC consists of a single item which asks the participant "Since the start of the study (treatment), my overall pain is..." and asks the participant to rate the pain on a 7-point Likert scale ranging from 0 ("Very much improved") to 6 ("Very much worse"), such that lower scores are associated with an overall impression of improvement since the start of the study. Results will be summarized by study arm using basic descriptive statistics.
Time frame: 1 month, 2 months, 3 months, and 9 months
Depressive Symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaire (PHQ-9). The PHQ assessment is a self-report scale which consists of 9 items that measure the frequency of mood-related symptoms experienced over the prior 2-week period. The 9 combined items are scored on a 4-point Likert scale ranging from 0 ("Not at all") to 3 ("Nearly every day"), yielding an overall possible scoring range of 0-27, wherein higher scores are indicative of a greater frequency of mood-related symptoms. Results will be summarized by study arm using basic descriptive statistics.
Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months
Anxiety Symptoms
Anxiety symptoms will be assessed using derivatives of the Generalized Anxiety Disorder-7 (GAD-7). The GAD assessment is a self-report scale which consists of 7 items that measure the frequency of anxiety-related symptoms experienced over the prior 2-week period. The 7 combined items are scored on a 4-point Likert scale ranging from 0 ("Not at all") to 3 ("Nearly every day"), yielding an overall possible scoring range of 0-21, wherein higher scores are associated with a greater frequency of anxiety-related symptoms. Results will be summarized by study arm using basic descriptive statistics.
Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months
Positive urine test for non-prescribed opioids
Positive urine test for non-prescribed opioids will be assessed using point of care urine drug testing. It is a dichotomous variable (yes/no) wherein yes is indicative of a positive test for oxycodone, fentanyl, or other opiates that were not indicated by participant as prescribed. Results will be summarized by study arm.
Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months
Physical Function Assessments - Fingertip-to-floor test
The fingertip-to-floor test measures the ability of the participant to bend to the floor from a standing position. The participant is asked to remove shoes and, without bending the knees, to bend forward at the waist and reach towards the floor with fingertips, keeping arms and knees extended. The distance in centimeters (cm) from the tip of the middle finger to the floor is measured. This can be repeated up to 3 times per participant and the best trial will be used/recorded. Shorter distances from the floor are indicative of greater flexibility. Results will be summarized by study arm using basic descriptive statistics.
Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months
Physical Function Tests - Short Physical Performance Battery (SPPB)
SPPB measures lower extremity function and mobility in 3 areas: Balance (side-by-side stand, semi-tandem stand, and tandem stand); Gait speed (3 meter walk test); and Strength (5 chair stands). Balance (side-by-side and semi-tandem stand): 1 point (pt) for each test they can hold for \>=10 seconds (s), and 0 pts for \<10s Balance (tandem stand): 2 pts for holding for \>=10s, 1 pt for holding from 3-9.99s, and 0 pts for holding \<3s Gait speed (time): 4 pts for \< 3.62s, 3 pts for 3.62-4.65s, 2 pts for 4.66-6.52s, 1 pt for \> 6.52s Strength: 4 pts for completing 5 chair stands in \<=11.19s, 3 pts for 11.20-13.69s, 2 pts for 13.70-16.69s, and 1 pt for \>=16.70s. 0 pts given if a participant is unable to complete 5 chair stands in \<60s or could not/would not attempt task Scores from the 3 areas are summed for an overall range of 1-12 with higher scores indicating better lower extremity function/mobility. Results will be summarized by study arm using basic descriptive statistics.
Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months
Physical Function, self-reported
General physical function will be measured using the PROMIS Physical Functioning Scale. This assessment consists of 6 items rated on a 5-point Likert scale ranging from 1 = "Unable to do the task" to 5 = "Able to do the task without difficulty or limitations" yielding an overall possible scoring range of 6-30, wherein higher scores are associated with better, self-reported, physical functioning. Results will be summarized by study arm using basic descriptive statistics.
Time frame: Baseline (Week 0), 3 months, 6 months, and 9 months
Back Pain-related Disability
Back pain-related disability will be measured with the Oswestry Low Back Pain Disability Questionnaire, a self-report scale which consists of 10 items that measure low back pain intensity and functional impact. Responses are scored on a 6-point Likert scale where 0 represents no functional limitation and 5 represents the most severe functional limitation, yielding an overall possible scoring range of 0-50. Results will be converted to a percentage of points score (=Score/50\*100) and summarized by study arm.
Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months
Fear Avoidance
The Fear Avoidance Beliefs Questionnaire-Physical Activity component (FABQ-PA) is a four-item questionnaire that assesses how participants believe and expect different physical activities would impact pain. Items are rated on a 7-point Likert scale ranging from 0 to 6, where 0 = "Completely disagree" to 6 = "Completely agree." Scores for the 4 items will be summed, to yield an overall possible score of 0 to 24. Higher scores are indicative of a greater fear-avoidance belief about physical activity. Scores will be summarized by study arm using basic descriptive statistics.
Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, and 9 months
Mindfulness
Mindfulness will be assessed using the Mindful Attention Awareness Scale (MAAS). The MAAS is a 15-item scale which measures mindful awareness using a 6-point Likert scale ranging from 1 = "Almost always" to 6 = "Almost never." The summary score is the mean of the 15 items, yielding an overall possible score ranging from 1-6, with higher scores indicating greater mindful awareness. Results will be summarized by summarized by study arm using basic descriptive statistics.
Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months
Intervention Session Attendance
For participants randomized to one of the intervention arms (yoga or PT), the number of intervention sessions attended, ranging from 0 to 12, will be determined. Mean attendance will be summarized by arm.
Time frame: 3 months
Retention in Medications for Opioid Use Disorder (MOUD)
Retention in MOUD is defined by whether the participant was still enrolled in care at the OTP AND received methadone or buprenorphine (yes/no). This will be assessed by electronic medical record review. Results will be summarized by study arm using basic descriptive statistics.
Time frame: Baseline (Week 0), 1 month, 2 months, 3 months, 6 months, and 9 months
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