Meditation-CBT for Opioid-treated Chronic Low Back Pain

Chronic Pain Clinical Trial

Official title:

Randomized Controlled Trial of Mindfulness Meditation and Cognitive Behavioral Therapy Intervention for Opioid-treated Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775995
• Other study ID #: 2012-0656
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 22, 2013
• Last updated: June 11, 2015
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: June 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Chronic low back pain (CLBP) is one of the most common, costly and disabling conditions. It is often refractory to treatment, with patients requiring long-term opioid therapy. Mindfulness meditation is a promising treatment for chronic pain, mental health and addictive disorders. When combined with cognitive behavioral therapy (CBT), a standard of care for CLBP, it may produce additive benefits. The goal of this randomized controlled trial (RCT) is to evaluate the feasibility and efficacy of an innovative behavioral intervention to improve the health of adults with opioid-treated CLBP. This RCT will test the hypotheses that, at 26 weeks, meditation-CBT group participants (meditation-CBT + usual care), compared to those in a wait-list control group (usual care alone), will improve health-related quality of life (primary outcomes: pain severity and physical function) and reduce opioid medication use (secondary outcome). In addition, they will also decrease alcohol and drug use/misuse, and improve stress-sensitive measures and economic outcomes.

Description:

Chronic low back pain (CLBP) is one of the most common, costly and disabling conditions. Treatment for refractory CLBP includes long-term opioid therapy even though it is often only marginally effective. Prescription opioid abuse is a national epidemic. Development of safe, effective non-addictive therapies for chronic pain is a national priority. Mindfulness meditation is a promising, safe treatment for chronic pain, mental health and addictive disorders. When combined with cognitive behavioral therapy (CBT), a standard of care for CLBP, it may produce additive benefits. No study has evaluated the potential of a combined meditation-CBT intervention to improve outcomes in patients with opioid-treated CLBP.

This unblinded 26-week pilot randomized controlled trial (RCT) will test methods feasibility and efficacy of meditation-CBT for improving health-related quality of life (primary outcomes: pain severity and physical function) and reduce opioid medication use (secondary outcome) among adults with opioid-treated CLBP. Eligible participants are adults at least 21 years old, with daily CLBP treated with daily opioids (at least 30 morphine-equivalent mg/day) for at least 3 months. They will be recruited from outpatient clinic and community settings, and randomly assigned to one of two study arms: meditation-CBT + usual care or usual care alone. The targeted meditation-CBT intervention will consist of a) therapist-led group training (two-hours/week for 8 weeks), and b) at-home meditation practice (at least 30 minutes/day, 6 days/week). Control participants will be offered the intervention after their study completion.

Outcome measures, collected at 0, 8 (directly post-intervention) and 26 (18 weeks post-intervention) weeks will gather data on efficacy and potential mechanisms of action of meditation-CBT intervention. This RCT will test the hypotheses that, at 26 weeks, meditation-CBT group participants (meditation-CBT + usual care), compared to those in a wait-list control group (usual care alone), will improve health-related quality of life (primary outcomes: pain severity and physical function) and reduce opioid medication use (secondary outcome). In addition, they will also decrease alcohol and drug use/misuse, and improve stress-sensitive measures and economic outcomes. Increased pain acceptance, mindfulness level or stress reduction are hypothesized to be the mechanistic pathways.

This study directly addresses national priorities aimed at the development of an effective, safe treatment for CLBP and reduction of opioid use. Potential benefits accruing from positive findings include improved quality of life and reduced opioid pain medication use among patients with refractory, opioid-treated CLBP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Age = 21 years old

• Chronic low back pain defined as a daily pain in the lumbosacral region or radiating to the leg (sciatica)

• Pain lasting for and treated with clinician-prescribed daily opioids (= 30mg of morphine equivalent dose, MED) for = 3 months

• Has the ability to feel warm and cold temperature sensations in both hands (for pain psychophysical testing)

• English fluent

Exclusion Criteria:

• Experience in meditation (current, regular practice in the past 12 months or past formal training)

• Inability to reliably participate

• Self-reported current pregnancy

• Preexisting delusional, bipolar, or borderline personality disorders

• Individuals lacking consent capacity and prisoners

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain

Intervention

Behavioral:
• Meditation-CBT Intervention + Usual Care
The intervention combines meditation and standard-of-care CBT strategies for chronic low back pain. It consists of eight weekly 2-hour group sessions guided by trained instructors. In addition to session attendance, experimental participants are asked to practice meditation at home at least 6 days/week, 30 minutes/day during the 26-week study. Control participants will be offered the intervention after completing the study. All participants receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.

Other:
• Usual Care Alone
All participants receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dr. Zgierska was supported by the K23AA017508 from the National Institutes of Health (NIH) National Institute on Alcohol Abuse and Alcoholism (NIAAA). The project was also supported by the Clinical and Translational Science Award (CTSA) program through the NIH National Center for Advancing Translational Sciences (NCATS), grant UL1TR000427. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Alcohol Use	Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.	Baseline	No
Other	Alcohol Use	Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.	8 weeks	No
Other	Alcohol Use	Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.	26 weeks	No
Other	Drug Use	Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.	Baseline	No
Other	Drug Use	Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.	8 weeks	No
Other	Drug Use	Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.	26 weeks	No
Other	Chronic Pain Acceptance	Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame.; This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance.	baseline to 8 weeks	No
Other	Chronic Pain Acceptance	Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame.; This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance.	baseline to 26 weeks	No
Other	Perceived Stress	Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure's total score (0-40) reflects the degree to which one perceives their life experiences as stressful "in the last month".; This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress.	baseline to 8 weeks	No
Other	Perceived Stress	Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure's total score (0-40) reflects the degree to which one perceives their life experiences as stressful "in the last month".; This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress.	baseline to 26 weeks	No
Other	Mental Health Symptom Severity	Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress "during the past 7 days".; This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress.	baseline to 8 weeks	No
Other	Mental Health Symptom Severity	Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress "during the past 7 days".; This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress.	baseline to 26 weeks	No
Other	Depression Symptom Severity	Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms "during the past 7 days".; This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms.	baseline to 8 weeks	No
Other	Depression Symptom Severity	Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms "during the past 7 days".; This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms.	baseline to 26 weeks	No
Other	Anxiety Symptom Severity	Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms "during the past 7 days".; This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms.	baseline to 8 weeks	No
Other	Anxiety Symptom Severity	Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms "during the past 7 days".; This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms.	baseline to 26 weeks	No
Other	Emotion Regulation Difficulty	Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified).; This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty.	baseline to 8 weeks	No
Other	Emotion Regulation Difficulty	Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified).; This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty.	baseline to 26 weeks	No
Other	C-Reactive Protein	Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes.; This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure).	baseline to 8 weeks	No
Other	C-Reactive Protein	Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes.; This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure).	baseline to 26 weeks	No
Other	Economic Outcomes	Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed.; Medications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs.; Cost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day).	6 months prior to baseline, to baseline (enrollment)	No
Other	Economic Outcomes	Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed.; Medications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs.; Cost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day).	From enrollment to 26 week follow-up (6 months)	No
Other	Pain Sensitivity to Experimental Thermal Stimuli	Pain sensitivity to thermal stimuli was assessed using standard psychophysical procedures. Thermal stimuli, ranging from 43 to 49oC, were applied to the thenar eminence of the right hand. Each stimulus was rated on two separate, validated 0-20 category-ratio scales assessing pain intensity and unpleasantness.	0, 8, 26 weeks	No
Primary	Health-Related Quality of Life: Averaged Pain Severity	Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.; This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased pain and negative values indicating decreased pain.	baseline to 8 weeks	No
Primary	Health-Related Quality of Life: Averaged Pain Severity	Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.; This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased pain and negative values indicating decreased pain.	baseline to 26 weeks	No
Primary	Health-Related Quality of Life: Physical Function	Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure's total score (0-100) reflects the percent of chronic low back pain related disability "today".; This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased disability and negative values indicating decreased disability.	baseline to 8 weeks	No
Primary	Health-Related Quality of Life: Physical Function	Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure's total score (0-100) reflects the percent of chronic low back pain related disability "today".; This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased disability and negative values indicating decreased disability.	baseline to 26 weeks	No
Secondary	Opioid Dose	Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized [daily morphine-equivalent dose (MED)] across different opioids for each participant.; This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose.	baseline to 8 weeks	No
Secondary	Opioid Dose	Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized [daily morphine-equivalent dose (MED)] across different opioids for each participant.; This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose.	baseline to 26 weeks	No