Group-based Mindfulness for Chronic Pain in the Primary Care Setting

Study Overview
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Brief Summary
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The purpose of this pragmatic clinical trial (PCT) research is to determine whether a group-visit approach modeled on Mindfulness-Based Stress Reduction can improve function for persons with chronic low back pain. This will be done by an embedded PCT within the evidence-based OPTIMUM (Optimizing Pain Treatment In Medical settings Using Mindfulness) program.

Detailed Description
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The research will be conducted with three health care system (HCS) sites: Boston Medical Center, MA, a safety net health system; UPMC, Pittsburgh, PA, a large health system; and Piedmont Health Services, NC, a network of federally funded health centers in partnership with the University of North Carolina (UNC), Chapel Hill. As per NIH protocol for the funding, the first 12 month (Phase 1) of this PCT will be a pilot to plan and test the group-based mindfulness program for chronic pain program in each of the three sites with 5 participants/site. Once completed the Phase 2 will be conducted to integrate and test the group-based mindfulness program compared to standard of care for patients with chronic low back pain (cLBP) in the primary care setting at each collaborating site. Eligible consenting participants will be randomized to either: the primary care providers (PCP) usual care group, or the group with both PCP usual care and the 8 weeks mindfulness clinical pain group. Participants will be asked to complete baseline and follow-up surveys about pain, function, pain medicine use, mood and anxiety symptoms, and quality of life. The surveys will take up to an hour to complete.

Official Title
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Group-based Mindfulness for Patients With Chronic Low Back Pain in the Primary Care Setting

Conditions
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Chronic Pain, Back Pain

Intervention / Treatment
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* Other: Group medical visits with mindfulness-based stress reduction
* Other: Usual PCP care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Chronic low back pain, which is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months A score ≥ 3 on the PEG Willing and able to provide online or telephone informed consent Speak English as the intervention manual is currently written in English Exclusion Criteria: Do not meet the above inclusion criteria Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss Pregnancy Metastatic cancer First-degree relatives (parents, siblings, child) of someone who has participated or is participating in the OPTIMUM study Members of the same household Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 12 or more months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Pain Program + Usual PCP Care<br>Participants will undergo 8 weekly 90 minute sessions of Mindfulness-Based Stress Reduction in addition to receiving usual PCP care for chronic lower back pain. | Other: Group medical visits with mindfulness-based stress reduction<br>* Eight weekly 90 minute sessions of mindfulness-based stress reduction in group medical visits<br>Other: Usual PCP care<br>* Usual one on one PCP care for chronic lower back pain<br>|
| Active Comparator: Usual PCP Care<br>Participants will receive usual PCP care for chronic lower back pain. | Other: Usual PCP care<br>* Usual one on one PCP care for chronic lower back pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity and interference at 8 weeks: PEG score | The PEG (pain, enjoyment, general activity) composite score will be used to assess pain intensity and interference. The PEG is a 3 item score with potential responses of 0 to 10 with 10 being the most severe pain. The 3 PEG items referring to the past week are: average pain, how pain interfered with enjoyment of life, how pain interfered with general activity To compute the PEG score, add the responses to the questions above, then divide by three to get a final score out of 10. | baseline, 8 weeks | 
| Pain intensity and interference at 6 months: PEG score | The PEG (pain, enjoyment, general activity) composite score will be used to assess pain intensity and interference. The PEG is a 3 item score with potential responses of 0 to 10 with 10 being the most severe pain. The 3 PEG items referring to the past week are: average pain, how pain interfered with enjoyment of life, how pain interfered with general activity To compute the PEG score, add the responses to the questions above, then divide by three to get a final score out of 10. | 6 month | 
| Pain intensity and interference at 12 months: PEG score | The PEG (pain, enjoyment, general activity) composite score will be used to assess pain intensity and interference. The PEG is a 3 item score with potential responses of 0 to 10 with 10 being the most severe pain. The 3 PEG items referring to the past week are: average pain, how pain interfered with enjoyment of life, how pain interfered with general activity To compute the PEG score, add the responses to the questions above, then divide by three to get a final score out of 10. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function at 8 weeks | Physical function will be assessed using the 4 item PROMIS (Patient Reported Outcome Measurement Information System). It measure self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), Each question usually has five response options ranging in value from one to five. Scores range from 4 to 20 and higher scores are more favorable. | 8 weeks | 
| Physical function at 6 months | Physical function will be assessed using the 4 item PROMIS (Patient Reported Outcome Measurement Information System). It measure self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), Each question usually has five response options ranging in value from one to five. Scores range from 4 to 20 and higher scores are more favorable. | 6 month | 
| Physical function at 12 months | Physical function will be assessed using the 4 item Patient Reported Outcome Measurement Information System (PROMIS). It measure self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), Each question usually has five response options ranging in value from one to five. Scores range from 4 to 20 and higher scores are more favorable. | 12 months | 
| Opioid prescription use at 8 weeks | The Current Opioid Misuse Measure® (COMM) will be used to assess opioid prescription use. It is a 17-item, patient self-assessment measure designed to identify individuals taking opioids. Scoring is based on a Likert 5-point scale from 0 (never) to 4 (very often). A score of 9 or above is a positive indicator, ie, participant has been identified as misusing his/her medication and is at an increased risk of abuse. | 8 weeks | 
| Opioid prescription use at 6 months | The Current Opioid Misuse Measure® (COMM) will be used to assess opioid prescription use. It is a 17-item, patient self-assessment measure designed to identify individuals taking opioids. Scoring is based on a Likert 5-point scale from 0 (never) to 4 (very often). A score of 9 or above is a positive indicator, ie, participant has been identified as misusing his/her medication and is at an increased risk of abuse. | 6 months | 
| Opioid prescription use at 12 months | The Current Opioid Misuse Measure® (COMM) will be used to assess opioid prescription use. It is a 17-item, patient self-assessment measure designed to identify individuals taking opioids. Scoring is based on a Likert 5-point scale from 0 (never) to 4 (very often). A score of 9 or above is a positive indicator, ie, participant has been identified as misusing his/her medication and is at an increased risk of abuse. | 12 months | 
| Use of healthcare resources by participants as documented in the EHR | The electronic health record (EHR) will be reviewed of each participants to ascertain the healthcare resources used. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness-Based Stress Reduction, Medical group visits, Primary care setting