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Mindfulness Meditation for Chronic Lower Back Pain (STAMP Trial)

N/A

Waitlist Available

Led By Aleksandra E Zgierska, MD PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Inclusion Criteria (per self-report): English-speaking; age ≥ 21 years old; chronic low back pain (defined as a pain in lumbosacral region or sciatica for ≥3 months), with an average daily back pain score ≥3 on a 0-10 numerical rating scale (question from the Brief Pain Inventory), treated with ≥30 mg/day of morphine-equivalent dose for ≥3 months; at least moderate CLBP-related disability (≥21 score on the Oswestry Disability Index); capable of giving informed consent; willing to complete the study activities.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months

Awards & highlights

STAMP Trial Summary

This trial will compare the effectiveness of mindfulness meditation to standard-of-care cognitive behavioral therapy in opioid-treated chronic low back pain.

Eligible Conditions

Chronic Lower Back Pain

STAMP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

STAMP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain Intensity

Physical Function

Secondary outcome measures

Daily Opioid Dose

Quality of Life

Other outcome measures

Anxiety Symptom Severity

Depression Symptom Severity

Opioid Medication Compliance

+1 more

Side effects data

From 2016 Phase 2 trial • 413 Patients • NCT01654289

Musculoskeletal

Cardiac Disorders

General

100%

80%

60%

40%

20%

Study treatment Arm

Exercise

Wait-list Control

Mindfulness Meditation

STAMP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness MeditationExperimental Treatment1 Intervention

Mindfulness Meditation intervention, adjunctive to usual care for opioid-treated chronic low back pain.

Group II: Cognitive Behavioral TherapyActive Control1 Intervention

Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness Meditation

2017

Completed Phase 2

~4780

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,180 Previous Clinical Trials

3,591,580 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

548 Previous Clinical Trials

29,995,618 Total Patients Enrolled

Aleksandra E Zgierska, MD PhDPrincipal InvestigatorPenn State University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there considerable facilities conducting this research in North America?

"Presently, 4 sites are participating in the study. These include Hershey, Salt Lake City and Madison as well as additional centres. To reduce any necessary travel demands on your part, it is advised to select a location that is nearby you geographically."

Answered by AI

Is this trial currently accepting enrollees?

"Clinicaltrials.gov confirms that the recruitment period for this clinical trial ended on November 30th 2022; however, there are 333 other studies currently open to new participants."

Answered by AI

Recent research and studies

Contemporary Clinical TrialsJournal

Mindfulness-based Therapy Compared to Cognitive Behavioral Therapy for Opioid-treated Chronic Low Back Pain: Protocol for a Pragmatic Randomized Controlled Trial

Zgierska, Aleksandra E., Cindy A. Burzinski, Eric L. Garland, Robert P. Lennon, Robert Jamison, Yoshio Nakamura, Bruce Barrett, et al.. 2021. “Mindfulness-based Therapy Compared to Cognitive Behavioral Therapy for Opioid-treated Chronic Low Back Pain: Protocol for a Pragmatic Randomized Controlled Trial”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2021.106548.

clinicaltrials.govStudy

Strategies to Assist With Management of Pain

2017. "Strategies to Assist With Management of Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03115359.