Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

Neural Mechanisms of Meditation-Based Interventions for Chronic Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607381
• Other study ID #: IRB_00133405
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: June 2027

Study information

• Verified date: March 2023
• Source: University of Utah
• Contact: Eric Garland, PhD
• Phone: 801-581-3826
• Email: eric.garland[@]socwk.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to see how a mindfulness meditation-based intervention affects pain. Specifically, we are interested in understanding the pain-relieving brain mechanisms of mindfulness meditation-based therapy for patients with opioid-treated chronic low back pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1) men/women 18-65 years of age; 2) current chronic low back pain classified according to the NIH Pain Consortium task force research standards for chronic low back pain (pain on at least half the days in the past 6 months); usual back pain =3 on 0-10 scale with opioid medication; and 4) current use of prescription opioids for =3 months.

Exclusion Criteria:

1) Prior experience with MBSR, MBCT, MORE, or extensive involvement in any standardized meditation training, 2) current cancer diagnosis, 3) suicide intent or attempt in the past 30 days, 4) psychosis or moderate/severe non-opioid substance use disorder in past 6 months; 5) persons with any electronic objects or certain metal objects in their head or body that are incompatible with MRI; 6) those who have had an abnormal brain MRI in the past; 7) those unable to lie still on their back for 1 to 1.5 hours; and 8) pregnancy.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Opioid Use

Intervention

Behavioral:
• Meditation
Participants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues.

Other:
• Usual care
Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).

Locations

Country	Name	City	State
United States	Center on Mindfulness and Integrative Health Intervention Development	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate variability	Changes in heart rate variability (HRV) measured with a 3-lead ECG.	At baseline and at post-treatment (8 weeks)
Other	Cue-reactivity	Cue-reactivity as evidenced by blood oxygenation level dependent (BOLD) signaling and cue-reactivity ratings during cue-exposure	At baseline and at post-treatment (8 weeks)
Primary	Blood oxygenation level dependent (BOLD) signaling	Changes in blood oxygenation levels to thermally noxious stimuli (48°C) will be assessed.	At baseline and at post-treatment (8 weeks)
Secondary	Visual Analog Scale Pain Ratings	Psychophysical Assessment of Pain: As previously in all of our previous pain studies, pain intensity and unpleasantness ratings will be assessed with a Visual Analog Scale. These scales 1) provide reliably separate assessment of experimental and clinical pain intensity and unpleasantness, 2) are internally consistent, and 3) approximate ratio scale measurement accuracy. The minimum rating ("0") is designated as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable" or "most unpleasant imaginable".	At baseline and at post-treatment (8 weeks)
Secondary	Chronic pain symptoms	Scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)	At baseline, post-treatment (8 weeks), and 3-month follow-up
Secondary	Opioid dose	Opioid dose as assessed with Timeline Followback Procedure	At baseline, post-treatment (8 weeks), and 3-month follow-up
Secondary	Pain catastrophizing	This is a 13-item questionnaire with 3 subscales assessing rumination, magnification, and helplessness in patients. A numeric value between 0 (not at all) and 4 (all the time) is provided in response to each statement. Scores on this assessment range from 0 to 52, with higher values reflecting more salient impacts of pain on one's day to day experience.	At baseline, post-treatment (8 weeks), and 3-month follow-up
Secondary	Self-transcendence	Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65)	At baseline, post-treatment (8 weeks), and 3-month follow-up
Secondary	Mindful reinterpretation of pain sensations	Mindful reinterpretation of pain sensations measured by the Mindful Reinterpretation of Pain Sensations Scale, with higher scores indicating higher reinterpretation of pain sensations (min 0, max 45)	At baseline, post-treatment (8 weeks), and 3-month follow-up
Secondary	Trait mindfulness	This is a 39-item multidimensional measure of trait mindfulness and includes five subscales: non-reactivity, nonjudgment, describing, observing, and acting with awareness. A numeric value between 1 (never or very rarely true) and 5 (very often or always true) is provided in response to each statement.	At baseline, post-treatment (8 weeks), and 3-month follow-up