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Behavioral Intervention

Spinal Manipulation and Mindfulness-Based Stress Reduction for Chronic Lower Back Pain

Q: 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, <a href="https://www.withpower.com/clinical-trials/north-carolina">North carolina</a>, a total of 119 sites have been operating studies for this drug.

Q: 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.

Q: Are applicants aged 45 or above eligible for inclusion in this medical trial?

This medical trial is only open to participants aged 18 - 75. However, there are 15 trials for minors and 293 studies that cater to individuals above the age of 65.

Q: Are there any openings for new participants in this clinical trial?

Affirmative. Clinicaltrials.gov offers evidence that this medical study, which initially went live on August 10th 2020, is currently enrolling participants. The research necessitates the recruitment of 240 individuals from two distinct locations.

Q: What kinds of conditions does Naloxone treat most frequently?

In addition to treating opioid overdose, Naloxone can be used therapeutically on patients presenting with <a href="https://www.withpower.com/clinical-trials/pain">pain</a>, itching and septic shock.

Q: Do I conform to the criteria necessary for participation in this experiment?

This medical trial seeks to enroll 240 individuals between the ages of 18 and 75 who experience chronic low <a href="https://www.withpower.com/clinical-trials/back-pain">back pain</a>. To be considered, participants must exhibit a minimum daily intensity level of 4 out 10 on the pain scale as well as 3 or more points of interference in their everyday activities for at least three months. Furthermore, they need not use opioid analgesics within 72 hours of each laboratory session (evidenced by drug screening), possess intact cognitive functioning and demonstrate proficiency with English reading and writing sufficient enough to comprehend study questionnaires and provide informed consent.

Phase < 1

Recruiting

Led By Stephen Bruehl, PhD

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

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

Must have

Significant daily chronic pain intensity (≥4 on a 10-point scale) and interference in performing daily activities due to pain (≥3 on a 10-point scale) for at least 3 months

Intact cognitive status and ability to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)

Awards & highlights

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.

Who is the study for?

This trial is for adults aged 18-75 with chronic low back pain, who experience significant daily pain and interference in daily activities. Participants must not be on opioids, have intact cognitive abilities, and be able to consent and complete questionnaires in English. Exclusions include severe health conditions like osteoporosis, recent lumbar surgery, high BMI (40+), certain mental health issues, substance abuse problems, or specific other pain conditions.Check my eligibility

What is being tested?

The study tests the effectiveness of Mindfulness Based Stress Reduction Therapy (MT) and Spinal Manipulation Therapy (SMT) against a placebo in reducing chronic lower back pain without relying on long-term opioid use. It will also examine changes in the body's own opioid function before and after treatment.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include discomfort or soreness from SMT sessions or emotional distress during MT sessions. Placebo typically has no side effects but can lead to perceived symptoms due to the placebo effect.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have had significant daily pain for at least 3 months that affects my daily activities.

Select...

I am mentally capable of understanding and agreeing to the study.

Select...

I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

Secondary outcome measures

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) Physical Function (Short Form)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: SMT plus placebo/naloxoneExperimental Treatment3 Interventions

Participants are randomly assigned to an 8 week SMT treatment group conducted by certified physical therapists. Immediately before and after the treatment sessions along with midway through the treatment (after 4 sessions), participants will undergo the placebo/naloxone administration intervention to assess mechanisms of SMT or MT-related changes.

Group II: MT plus placebo/naloxoneExperimental Treatment3 Interventions

Participants are randomly assigned to an 8 week MT treatment group conducted by certified clinical therapists. Immediately before and after the treatment sessions along with midway through the treatment (after 4 sessions), participants will undergo the placebo/naloxone administration intervention to assess mechanisms of SMT or MT-related changes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Naloxone

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,261 Total Patients Enrolled

Vanderbilt University Medical CenterOTHER

857 Previous Clinical Trials

671,953 Total Patients Enrolled

Stephen Bruehl, PhDPrincipal InvestigatorVanderbilt University Medical Center

2 Previous Clinical Trials

237 Total Patients Enrolled

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

Are applicants aged 45 or above eligible for inclusion in this medical trial?

"This medical trial is only open to participants aged 18 - 75. However, there are 15 trials for minors and 293 studies that cater to individuals above the age of 65."

Answered by AI

Are there any openings for new participants in this clinical trial?

"Affirmative. Clinicaltrials.gov offers evidence that this medical study, which initially went live on August 10th 2020, is currently enrolling participants. The research necessitates the recruitment of 240 individuals from two distinct locations."

Answered by AI

What kinds of conditions does Naloxone treat most frequently?

"In addition to treating opioid overdose, Naloxone can be used therapeutically on patients presenting with pain, itching and septic shock."

Answered by AI

Do I conform to the criteria necessary for participation in this experiment?

"This medical trial seeks to enroll 240 individuals between the ages of 18 and 75 who experience chronic low back pain. To be considered, participants must exhibit a minimum daily intensity level of 4 out 10 on the pain scale as well as 3 or more points of interference in their everyday activities for at least three months. Furthermore, they need not use opioid analgesics within 72 hours of each laboratory session (evidenced by drug screening), possess intact cognitive functioning and demonstrate proficiency with English reading and writing sufficient enough to comprehend study questionnaires and provide informed consent."

Answered by AI