Chronic Low Back Pain and Meditation

Pain Clinical Trial

Official title:

The Role of Endogenous Opioids in Mindfulness-based Chronic Pain Relief

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04034004
• Other study ID #: 190709
• Secondary ID: R21AT010352
• Status: Completed
• Phase: Early Phase 1
• Start date: January 1, 2021
• Est. completion date: December 22, 2022

Study information

• Verified date: October 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to see if and how mindfulness meditation affects pain. Specifically, we are interested in assessing if mindfulness is associated with the release of naturally occurring opiates in the body, in response to intravenous (IV) administration of the opioid antagonist naloxone during a chronic low back pain provoking procedure.

Description:

The purpose of this psychophysical and pharmacologic study is to determine if meditation induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during a pain evoking straight leg raise test in response to double-blind intravenous administration (IV) of naloxone/placebo-saline. The aim of this study is to determine if mindfulness-based analgesia is associated with the release of endogenous opioids.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants must have a medical evaluation that demonstrates chronic low back pain that is evoked by lifting the legs. Existing medical records, per physician discretion and low back examinations will confirm diagnosis
• Participants must be between 18 and 65 years of age
• Participants must rate their daily chronic pain intensity at a 3 or higher on 0-10 visual analog scale
• Participants must have experienced their chronic low back pain for at least 3 months
• Participants must have no prior meditative experience
• Participants must be straight leg raise test positive

Exclusion Criteria:

• Participants must not be participating in any new (within 2 weeks prior or anytime after enrollment) pain management procedures during the study period
• Participants must not be taking opioids
• Participants must not be pregnant or nursing mothers
• Participants must have not had back surgery within the last year before their enrollment into the study
• Participants must have not had any other sensory or motor deficits that preclude participation in this study
• Participants must not have known anomalies of the central nervous system including:

stroke, dementia, aneurysm, and a personal history of psychosis

• Participants must not have any known allergies to naloxone or similar drugs
• Participants must not have a history of syncope and/or fear of needles/blood

Related Conditions & MeSH terms

• Pain

Intervention

Behavioral:
• Mindfulness
A well-validated brief meditation-based mental training regimen [four sessions; 20 min/session] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.

Drug:
• Naloxone
A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.

Other:
• Saline
A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.

Behavioral:
• Meditation
A well-validated brief meditation-based mental training regimen [four sessions; 20 min/session] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.

Locations

Country	Name	City	State
United States	Altman Clinical and Translational Research Institute	La Jolla	California
United States	UC San Diego Center for Mindfulness	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

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* Note: There are 54 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SF-12 Health Survey (SF-12) Physical Functioning	This is a 12-item version of the SF-12 item Health Survey designed to assess general mental and physical functioning, and overall health-related quality of life. We used the physical functioning SF-12 scale and collected this information before and after each intervention and by group. The total range of scores is from 0 - 100. The minimum total score is 0 and the maximum score is 100. Higher scores indicate better functioning.	Up to 8 weeks. Administered at visit 1, 6 and 7. Outcome measurements will compare SF-12 health survey from baseline to session 7.
Primary	Pain Ratings	Numerical pain ratings (NRS) will be assessed while lying on the back and in response to the straight leg raise test (SLR). Pain ratings will be collected during SLR 1 and SLR 2 in the baseline, saline and naloxone sessions, respectively. The 11 point scan will include a minimum rating of "0" which is characterized as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable"." Higher numbers correspond to higher pain.	Pain ratings were collected while lying supine and in response to the straight leg raise test. Collected twice, once in the first half and one in the second half of the baseline, saline infusion and naloxone infusion sessions. Up to 8 weeks total.
Secondary	Pain Catastrophizing Scale	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. The total range is from 0 - 52.	The Pain Catastrophizing Scale was administered at the baseline, post-intervention session 6 and session 7. Outcome measurements will compare change in Pain Catastrophizing Scale from baseline to session 7.
Secondary	The Roland-Morris Disability Questionnaire (RMDQ)	The Roland-Morris Questionnaire (RMDQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMDQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain. Higher scores indicate greater disability. Total RMDQ scores are used before and after each intervention by group. The range of scores is from 0 - 24.	The Roland-Morris Disability Questionnaire was administered at the baseline, post-intervention session 6 and session 7. Outcome measurements will compare RMDQ from baseline to session 7.
Secondary	Brief Pain Inventory (BPI)	Pain severity and interference: impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. Higher scores indicate higher chronic pain. BPI severity and interference scales are used and collected before and after each intervention. Higher BPI severity indicate higher chronic pain severity. Higher BPI interference scores indicate higher chronic pain interference.The scoring scale for severity and interference range from 0 - 10, respectively.	Administered at the baseline, post-intervention session 6 and post-intervention session 7. Outcome measurements will compare in BPI severity and interference from baseline to session 7.