Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Meditation
BehavioralParticipants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues.
Usual care
Other interventionParticipants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).
Treatment groups
188 Participants
are divided into 3 treatment groupsGroup A: MindfulnessExperimental treatment 2 interventions
Group B: MeditationExperimental treatment 2 interventions
Group C: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Blood oxygenation level dependent (BOLD) signaling
Changes in blood oxygenation levels to thermally noxious stimuli (48°C) will be assessed.
Time frame
At baseline and at post-treatment (8 weeks)Secondary outcomes
1
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".
Time frame
At baseline and at post-treatment (8 weeks)2
Chronic pain symptoms
Scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10)
Time frame
At baseline, post-treatment (8 weeks), and 3-month follow-up3
Opioid dose
Opioid dose as assessed with Timeline Followback Procedure
Time frame
At baseline, post-treatment (8 weeks), and 3-month follow-up4
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.
Time frame
At baseline, post-treatment (8 weeks), and 3-month follow-upOther outcomes
1
Heart rate variability
Changes in heart rate variability (HRV) measured with a 3-lead ECG.
Time frame
At baseline and at post-treatment (8 weeks)2
Cue-reactivity
Cue-reactivity as evidenced by blood oxygenation level dependent (BOLD) signaling and cue-reactivity ratings during cue-exposure
Time frame
At baseline and at post-treatment (8 weeks)Sponsors and contacts
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Source ClinicalTrials.gov