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

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ClinicalTrials.gov Identifier: NCT04129450
Recruitment Status : Not yet recruiting
First Posted : October 16, 2019
Last Update Posted : December 6, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Boston Medical Center

Brief Summary:

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.

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Back Pain Other: Group medical visits with mindfulness-based stress reduction Other: Usual PCP care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Group-based Mindfulness for Patients With Chronic Low Back Pain in the Primary Care Setting
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness Pain Program + Usual PCP Care
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
Eight weekly 90 minute sessions of mindfulness-based stress reduction in group medical visits

Other: Usual PCP care
Usual one on one PCP care for chronic lower back pain

Active Comparator: Usual PCP Care
Participants will receive usual PCP care for chronic lower back pain.
Other: Usual PCP care
Usual one on one PCP care for chronic lower back pain




Primary Outcome Measures :
  1. Change in pain intensity and interference at 8 weeks: PEG score [ Time Frame: baseline, 8 weeks ]
    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.

  2. Pain intensity and interference at 6 months: PEG score [ Time Frame: 6 month ]
    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.

  3. Pain intensity and interference at 12 months: PEG score [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Physical function at 8 weeks [ Time Frame: 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.

  2. Physical function at 6 months [ Time Frame: 6 month ]
    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.

  3. Physical function at 12 months [ Time Frame: 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.

  4. Opioid prescription use at 8 weeks [ Time Frame: 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.

  5. Opioid prescription use at 6 months [ Time Frame: 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. Opioid prescription use at 12 months [ Time Frame: 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.

  7. Use of healthcare resources by participants as documented in the EHR [ Time Frame: 12 months ]
    The electronic health record (EHR) will be reviewed of each participants to ascertain the healthcare resources used.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic low back pain, that 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.
  • Willing and able to provide informed consent.
  • Speak English as the intervention manual is currently written in English.

Exclusion Criteria:

  • In the past month, worsening of pain, unexplained fever, unexplained weight loss
  • Back injury in the past 3 months
  • Pregnancy
  • Metastatic cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129450


Contacts
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Contact: Natalia Morone, MD, MS 617-414-6652 natalia.morone@bmc.org

Sponsors and Collaborators
Boston Medical Center
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Natalia Morone, MD, MS Boston Medical Center

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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT04129450    
Other Study ID Numbers: H-39165
UG3AT010621 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
Mindfulness-Based Stress Reduction
Medical group visits
Primary care setting
Additional relevant MeSH terms:
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Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms