Chronic PainPhase 1/2NCT01775995

Meditation-CBT for Opioid-treated Chronic Low Back Pain

A Phase 1/2 study of Chronic Pain and Low Back Pain, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Chronic Pain, Low Back Pain
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Jan 2013to Dec 2013
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin-Madison
Madison, Wisconsin, 53715

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions: Chronic Pain, Low Back Pain
Being tested: Meditation-CBT Intervention + Usual Care, Usual Care Alone
Keywords: Chronic Pain, Low Back Pain
Medical subject headings: Chronic Pain, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Meditation-CBT Intervention + Usual CareBehavioural
Also called Mindfulness Meditation, Meditation, Mindfulness, 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.
Usual Care AloneOther
All participants receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.

Study groups in NCT01775995
Study group	Role	What they receive
Meditation-CBT	Experimental	Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management. Receives: Behavioral: Meditation-CBT Intervention + Usual Care
Wait-list Control	Other	Participants receiving usual care for CLBP and opioid therapy management. Receives: Other: Usual Care Alone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline to 8 weeks
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.
Measured: baseline to 26 weeks
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.
Measured: baseline to 8 weeks
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.
Measured: baseline to 26 weeks

Secondary outcomes (2)

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.
Measured: baseline to 8 weeks
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.
Measured: baseline to 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Dec 2013

First posted25 Jan 2013 (estimated)
Study startJan 2013
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01775995
Sponsor's protocol ID: 2012-0656
Status last verified: Apr 2016
First submitted: 22 Jan 2013
Last updated: 16 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
Zgierska AE, Burzinski CA, Cox J, Kloke J, Stegner A, Cook DB, Singles J, Mirgain S, Coe CL, Backonja M. Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial. Pain Med. 2016 Oct;17(10):1865-1881. doi: 10.1093/pm/pnw006. Epub 2016 Mar 10.
PubMed 26968850

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of Mindfulness Meditation and Cognitive Behavioral Therapy Intervention for Opioid-treated Chronic Low Back Pain
ClinicalTrials.gov ID: NCT01775995
Acronym / sponsor ID: 2012-0656
Conditions: Chronic Pain, Low Back Pain
Keywords: Chronic Pain, Low Back Pain
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Study start: Jan 2013
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 25 Jan 2013 (estimated)
Results: Posted 4 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Meditation-CBT	Experimental	Behavioral: Meditation-CBT Intervention + Usual CareParticipants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
Wait-list Control	Other	Other: Usual Care AloneParticipants receiving usual care for CLBP and opioid therapy management.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Meditation-CBT Intervention + Usual CareAlso: Mindfulness Meditation, Meditation, Mindfulness, Usual careThe 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.	Behavioural	Meditation-CBT
Usual Care AloneAll participants receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.	Other	Wait-list Control

Primary outcome

Health-Related Quality of Life: Averaged Pain Severity
Time frame: baseline to 8 weeks
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.
Health-Related Quality of Life: Averaged Pain Severity
Time frame: baseline to 26 weeks
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.
Health-Related Quality of Life: Physical Function
Time frame: baseline to 8 weeks
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.
Health-Related Quality of Life: Physical Function
Time frame: baseline to 26 weeks
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.

2 secondary outcomes

Opioid Dose
Time frame: baseline to 8 weeks
Opioid Dose
Time frame: baseline to 26 weeks

Results and safety

Results posted to the registry on 4 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Meditation-CBT	21	20
Wait-list Control	14	13

Primary outcome: Health-Related Quality of Life: Averaged Pain Severity

Time frame: baseline to 8 weeks. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Meditation-CBT n = 20	Wait-list Control n = 14
Value	-0.5 (-1.1 to 0.03)	0.4 (-0.3 to 1.0)

Population analysed: One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.

Primary outcome: Health-Related Quality of Life: Averaged Pain Severity

Time frame: baseline to 26 weeks. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Meditation-CBT n = 20	Wait-list Control n = 13
Value	-0.5 (-1.1 to 0.02)	0.5 (-0.2 to 1.2)

Population analysed: One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.

Primary outcome: Health-Related Quality of Life: Physical Function

Time frame: baseline to 8 weeks. Mean (95% Confidence Interval). Unit: percentage disability

Measure	Meditation-CBT n = 20	Wait-list Control n = 14
Value	-2.4 (-7.2 to 2.3)	-0.6 (-6.2 to 5.1)

Population analysed: One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.

Primary outcome: Health-Related Quality of Life: Physical Function

Time frame: baseline to 26 weeks. Mean (95% Confidence Interval). Unit: percentage disability

Measure	Meditation-CBT n = 20	Wait-list Control n = 13
Value	-5.0 (-9.7 to -0.2)	1.6 (-4.3 to 7.4)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental: Meditation-CBT	0 of 21 (0%)	7 of 21 (33.3%)	Not reported
Wait-list Control	0 of 14 (0%)	0 of 14 (0%)	Not reported

Limitations and caveats (from the sponsor): Lack of blinding of study staff to group status (except the statistician who was blinded during initial primary analyses); conducting most study related activities by the same core group of research staff may have introduced bias and placebo effect.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundDr. 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.
Derived from this study: PubMed 26968850Zgierska AE, Burzinski CA, Cox J, Kloke J, Stegner A, Cook DB, Singles J, Mirgain S, Coe CL, Backonja M. Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial. Pain Med. 2016 Oct;17(10):1865-1881. doi: 10.1093/pm/pnw006. Epub 2016 Mar 10.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aleksandra Zgierska, MD PhD principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study of Chronic Pain and Low Back Pain, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-Related Quality of Life: Averaged Pain Severity (time frame: baseline to 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01775995, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.