Study Summary
This trial will aim to test the effectiveness of mindfulness therapy and spinal manipulation therapy in reducing the need for chronic high-dose opioids by measuring changes in endogenous opioid function.
Eligible Conditions
- Chronic Lower Back Pain
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)
Week 16
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (Short Form)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
SMT plus placebo/naloxone
1 of 2
MT plus placebo/naloxone
1 of 2
Experimental Treatment
240 Total Participants · 2 Treatment Groups
Primary Treatment: Spinal Manipulation Therapy (SMT) · Has Placebo Group · Phase < 1
SMT plus placebo/naloxoneExperimental Group · 3 Interventions: Spinal Manipulation Therapy (SMT), Naloxone, Placebo · Intervention Types: Other, Drug, Drug
MT plus placebo/naloxoneExperimental Group · 3 Interventions: Naloxone, Placebo, Mindfulness Based Stress Reduction Therapy (MT) · Intervention Types: Drug, Drug, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naloxone
FDA approved
Placebo
1995
Completed Phase 3
~2640
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)
Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
391 Previous Clinical Trials
153,397 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
784 Previous Clinical Trials
599,088 Total Patients Enrolled
John Burns, PhDPrincipal InvestigatorRush University Medical Center
Stephen Bruehl, PhDPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
237 Total Patients Enrolled
Eligibility Criteria
Age 18 - 75 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have been experiencing daily chronic pain that is at least 4 out of 10 on a pain scale and it has been affecting your ability to do daily activities for at least 3 months.
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Frequently Asked Questions
Are there any existing reports of research involving Naloxone?
"Presently, 38 clinical trials examining the efficacy of Naloxone are active globally with 9 in their final stage. While the majority of them occur in Durham, North Carolina, a total of 119 sites have been operating studies for this drug." - Anonymous Online Contributor
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How many participants are taking part in the investigation?
"Affirmative. According to clinicaltrials.gov, this clinical trial is actively looking for participants; the study was initially published on August 10th 2020 and has been recently updated on November 22nd 2022. It aims to recruit 240 individuals from 2 separate locations." - Anonymous Online Contributor
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Are applicants aged 45 or above eligible for inclusion in this medical trial?
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Are there any openings for new participants in this clinical trial?
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What kinds of conditions does Naloxone treat most frequently?
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Do I conform to the criteria necessary for participation in this experiment?
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