Physical Therapy Integrated With Mindfulness for Patients With Chronic Musculoskeletal Pain and Long-Term Opioid Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Aim #3: Opioid MMEs on Timeline followback (TLFB)
研究概览
简要总结
This study will use multiple methods to assess the feasibility of conducting a fully powered multisite clinical trial to test the effectiveness of integrating mindfulness-based interventions into physical therapy for patients with chronic musculoskeletal pain and long-term opioid treatment.
First, researchers will develop a manual for training physical therapists to provide mindfulness-based interventions to patients with chronic musculoskeletal pain and long-term opioid treatment. Next, the researchers will evaluate the competency of physical therapists to provided mindfulness-based interventions after being randomized to one of 3 different mindfulness training arms. Patients scheduled for physical therapy with the randomized physical therapists will be invited to enroll in the study. These patients will be asked to complete a variety of patient reported outcomes including self-reported average pain and the the amount of prescription opioid pain medication taken.
详细描述
Chronic musculoskeletal pain is a leading cause of years lived with disability world-wide and the costliest health condition in the United States. An estimated 20%-30% of persons with chronic musculoskeletal pain use opioids for pain management. In recent years, the prevalence of long-term opioid treatment (LTOT) has increased in patients with musculoskeletal pain. Physical therapy (PT) is a common nonpharmacologic treatment recommended for chronic musculoskeletal pain. Studies suggest PT for musculoskeletal pain may reduce the likelihood of initiating opioid therapy and may protect against LTOT, but the role of PT as part of a multi-modal strategy to manage patients with chronic musculoskeletal pain and LTOT has not been investigated. Combining exercise-based interventions with mindfulness practices is effective for patients with chronic musculoskeletal pain, and engaging in mindfulness practices leads to a reduction in opioid dose in patients with chronic pain and LTOT. This is a feasibility study that will assess effectiveness of physical therapists in managing patients with chronic musculoskeletal pain and LTOT using mindfulness practices. the results of an aim may result in changes to the procedures of a subsequent aim.
This study is organized into three Aims that will be conducted consecutively.
Aim #1: is to refine and manualize physical therapist-led mindfulness-based interventions integrated with evidence-based PT (I-EPT) for patients with chronic musculoskeletal pain and LTOT. Our approach will use semi-structured interviews of 15 patients and 15 physical therapists to refine I-EPT.
Aim #2: Evaluate different intensities of a physical therapist training programs for the refined I-EPT treatment protocol. Our approach will be to randomize 45 physical therapists to 1 of 3 training arms (no training; low-intensity training; high-intensity training).
Aim #3: Evaluate the feasibility of the I-EPT intervention across domains of the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. We anticipate 90 patient participants will be enrolled onto the schedules of the randomized physical therapists in Aim 2. Semi-structured qualitative interviews will be conducted. For these interviews there will be separate cohorts of 27 participants from Utah and 27 from Florida. Each cohort will contain approximately 8 physical therapists (4 each from the HIghIT and LowIT programs), 13 patients and 7 between support staff, and clinic managers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
盲法说明
Lead statistician is also masked
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
- 是
入选标准
- •Physical Therapist Inclusion Criteria:
- •Employed at least .50 FTE (Full Time Equivalent)
- •Self Report managing patients with chronic musculoskeletal conditions
排除标准
- •Aim 2 and 3
- •Physical Therapist Inclusion Criteria:
- •Employed at least .50 FTE (Full Time Equivalent)
- •Self Report managing patients with chronic musculoskeletal conditions
- •Physical Therapist Exclusion Criteria:
- •-Attended any experiential (i.e., practice sessions with real or simulated patients) mindfulness training to be used for patient care
- •Attended any patient care specific mindfulness training lasting more than 3 hours.
- •Self-report using mindfulness interventions such as savoring and cognitive reappraisal (core components of MORE) as a primary intervention strategy for the majority of their caseload for patients with chronic musculoskeletal conditions.
- •Aims 1, 2 and 3
- •Patient Inclusion Criteria:
- •Age 18-75
- •English Speaking
- •Diagnosis of musculoskeletal pain condition involving the spine and/or peripheral joint(s)
- •Current musculoskeletal pain present for greater than or equal to 3 months.
- •Use of prescription opioids for most of the last 90 days (self-report)
- •Patient Exclusion Criteria:
- •Currently pregnant
- •Currently receiving mind-body treatment for musculoskeletal pain from a healthcare provider (e.g. PT, chiropractic, massage therapy, etc)
- •Currently receiving treatment for substance use disorder
- •Musculoskeletal pain condition related to a fracture or surgical procedure in the past 6 months.
研究组 & 干预措施
Evidence based physical therapy combined with mindfulness (Low-Intensity)
Physical therapists randomized to this arm will receive a manual on how to integrate MORE; mindfulness, mindful reappraisal, and mindful savoring savoring into routine outpatient physical therapy for patients with chronic musculoskeletal pain and long-term opioid treatment.
After 4 weeks to review the manual, the physical therapist's competency will be assessed during mock patient encounters using trained actors as standardized patients.
Patients with chronic musculoskeletal pain and long-term opioid treatment who seek care from a physical therapist in this arm will be approached to participate in the study. If eligible and willing to participate in the study they will be asked questions about pain and opioid use before, and after treatment. We plan on enrolling 2 patients for each physical therapist.
干预措施: Mindfulness based practice (Behavioral)
Standard physical therapy
Physical therapists randomized to this arm will deliver routine treatment for someone with chronic musculoskeletal pain and long-term opioid treatment.
Patients with chronic musculoskeletal pain and long-term opioid treatment who seek care from a physical therapist in this arm will be approached to participate in the study. If eligible and willing to participate in the study they will be asked questions about pain and opioid use before, during and after treatment. We plan on enrolling 2 patients for each physical therapist.
干预措施: Control/Standard Physical Therapy (Behavioral)
Evidence based physical therapy combined with mindfulness (High-Intensity)
Physical therapists randomized to this arm will receive 13 hours of training. The first 6 hours consists of prerecorded didactic lectures that the physical therapist can view on their own time. After viewing the lectures, participants will attend 6.25 hours of live experiential instruction to promote trainee competence in providing mindfulness, mindful reappraisal, and mindful savoring after which the participating physical therapist's competency will be assessed during mock patient encounters using trained actors as standardized patients. .
Patients with chronic musculoskeletal pain and long-term opioid treatment who seek care from a physical therapist in this arm will be approached to participate in the study. If eligible and willing to participate in the study they will be asked questions about pain and opioid use before, and after treatment. We plan on enrolling 2 patients for each physical therapist.
干预措施: Mindfulness based practice (Behavioral)
结局指标
主要结局
Aim #3: Opioid MMEs on Timeline followback (TLFB)
时间窗: 12 weeks
Percentage of TLFBs collected at 12 weeks The TLFB collects number of morphine milligram equivalents taken by the patient over the past 4 weeks
Aim #2: Mindfulness Oriented Recovery Enhancement fidelity measure
时间窗: 6 - 8 weeks after I-EPT live training
Mindfulness Oriented Recovery Enhancement fidelity (Modified MORE-FM) Version 2.0 measure score during post-training competency assessment of physical therapists (physical therapists randomized to High and Low Intensity training groups) 9 item scale - each item scored 0-6. Scores are summed and averaged.
Aim 3: PEG (Pain, Enjoyment, General activity)
时间窗: 12 weeks
Percentage of The Pain, Enjoyment and General Active (PEG) scales collected at 12 weeks The PEG measures pain intensity, enjoyment of life and general activity each on a 0 - 10 with higher scores indicating worse pain impact. The score is the average of all items.
次要结局
- Aim #2: Physical therapist retention (competency assessment)(6 - 8 weeks after I-EPT live training)
- Aim #2: Physical therapist enrollment(At recruitment)
- Aim #3 Patient Reported: Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b (PROMIS-6b)(baseline, 6 and 12 weeks)
- Aim #3 Patient Reported: Patient Global Impression Scale-Change(6 and 12 weeks)
- Aim #3 Patient Reported: Pain Self-Efficacy Questionnaire (PSEQ)(baseline, 6 and 12 weeks)
- Aim #3 Patient Reported: Mindfulness-Five Facet Mindfulness Questionnaire (FFMQ)(baseline, 6 and 12 weeks)
- Aim #3 Patient Reported: Short Assessment of Patient Satisfaction(6 and 12 weeks)
- Aim #3 Reach: Patients offered and enrolled(At recruitment)
- Aim #2: Randomized physical therapists(At recruitment)
- Aim #3 Reach: Physical therapists with enrolled patients(At recruitment)
- Aim #3 Adoption: Qualitative interviews(12 weeks)
- Aim #3: Physical therapist retention(12 weeks)
- Aim # 3 Adoption: Patients receiving MORE Components(12 weeks)
- Aim #1 Qualitative Interviews(1 month)
- Aim #3: Opioid MMEs on Timeline followback (TLFB)(Baseline 6 and 12 weeks)
- Aim 3: PEG (Pain, Enjoyment, General activity)(baseline, 6 and 12 weeks)
- Aim #3 Patient Reported: Positive Reappraisal Subscale of Cognitive Emotion Regulation Questionnaire (reappraisal subscale)(baseline, 6 and 12 weeks)
- Aim #3 Patient Reported: Participant-report health care utilization measures(4, 8 and 12 weeks)
- Aim #3 Implementation: Percentage of patients managed by PT(12 weeks)
- Sleep duration(baseline, 6 and 12 weeks)
- Aim #3 Patient Reported: The International Pain Activity Questionnaire (IPAQ) short form measures physical activity(Baseline, 6 and 12 weeks)
- Aim #3 Implementation: Fidelity(12 weeks)
- Aim #3: Adoption, Maintenance and Implementation: Qualitative Interviews(12 weeks)
- Aim # 3: Adoption: Patient retention(baseline, 6 and 12 weeks.)
- Aim # 3 implementation: Modified version of the Mindfulness Oriented Recovery Enhancement - Functional Measure during patient encounters.(12 weeks)
- Aim #3 Patient Reported: Pain Catastrophizing Scale (PCS) short form(baseline, 6 and 12 weeks)
- Aim #3 Patient Reported:Patient Reported Outcomes Measurement Information System (PROMIS)PROMIS Sleep Disturbance Short Form 6a(baseline, 6 and 12 weeks)
- Aim #3 Patient Reported: Patient Health Questionnaire-2 (PHQ-2)(baseline, 6 and 12 weeks)
- Aim #3 Patient Reported: Generalized Anxiety Disorder-2 (GAD-2)(baseline, 6 and 12 weeks)
- Aim #3 Patient Reported: Savoring Beliefs Inventory(baseline, 6 and 12 weeks)
- Aim #3. Patient Reported: Working Alliance Inventory - Short Short Revised (WAI-SR) Client Version(4, 8 and 12 weeks)
- Aim #3 Adoption: Mindfulness Oriented Recovery Enhancement component (MORE)(12 weeks)
- Aim #3 Effectiveness: REDCap Outcomes Collected(12 weeks)
- Aim #3: Screened patients(At recruitment)
- Aim #3: Patient retention(baseline, 6 weeks, 12 weeks)
- Aim #3: Adherence(12 weeks)
- Aim # 3 Adherence(weekly for 12 weeks)
研究者
Jake Magel
Associate Professor
University of Utah