Efficacy of Spinal Manipulation Therapy or Mindfulness-based Reduction Therapy on Patients With Chronic Low Back Pain

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Collaborator: Vanderbilt University Medical Center
• Treatments: Naloxone

Criteria

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