Efficacy of Spinal Manipulation Therapy or Mindfulness-based Reduction Therapy on Patients With Chronic Low Back Pain
Active, not recruitingEarly phase 1NCT04744883
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Chronic Pain Management (CPM) has increasingly utilized long-term opioid analgesic therapy, a change associated with increased opioid abuse (a greater exposure in vulnerable individuals), non-pain health consequences (hormone changes, falls), and a dramatic rise in opioid-related overdoses and deaths. Treatment strategies that minimize the need for chronic high-dose opioids are sorely needed. This project will aim to test what degree mindfulness therapy (MT) and spinal manipulation therapy (SMT) produce pre- to mid- to post-treatment changes in endogenous opioid (EO) function.
Study details
- Official title
- Evaluating Specific and Non-Specific Mechanisms in Two Distinct Complementary/Integrative Interventions for Chronic Pain
- Conditions
- Interventions
- Other: Spinal Manipulation Therapy (SMT)
- Drug: Naloxone
- Drug: Placebo
- Behavioral: Mindfulness Based Stress Reduction Therapy (MT)
- Sponsor
- Rush University Medical Center
- Collaborators
- Vanderbilt University Medical Center
- Start date
- 2020-08-15
- Primary completion
- 2024-11-29
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. 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 2. age 18-75 years (inclusive) 3. not using opioid analgesics on a daily basis or within 3 days of each laboratory session (confirmed via urine drug screen) 4. Intact cognitive status and ability to provide informed consent 5. ability to read and write in English sufficiently to understand and complete study questionnaires Exclusion Criteria: 1. meet criteria for alcohol or substance abuse problems 2. meet criteria for past or present psychotic or bipolar disorders 3. inability to understand English well enough to complete questionnaires or participate in therapy 4. pain due to malignant conditions, rheumatoid arthritis, migraine or tension headache, complex regional pain syndrome, or fibromyalgia syndrome 5. lumbar surgery within past 6 months 6. pregnant 7. signs of nerve root compression (ie, positive straight-leg raise \<45○). 8. liver diseases (e.g hepatitis or cirrhosis) 9. suicide ideation with intent 10. osteoporosis or bone demineralization 11. opioid-dependency 12. inability to hold breathe for 15 seconds 13. acute trauma to spine 14. long term use of corticosteroids 15. spinal cord stimulator or IT pump inserted in back 16. they have a BMI equal to or above 40
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04744883