Status:
ACTIVE_NOT_RECRUITING
Efficacy of Spinal Manipulation Therapy or Mindfulness-based Reduction Therapy on Patients With Chronic Low Back Pain
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
Vanderbilt University Medical Center
Conditions:
Chronic Low-back Pain
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief 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 hea...
Detailed Description
This project will determine whether enhancing endogenous opioids (via SMT or MT) permits achieving desired levels of analgesia with lower dosages of opioid analgesics, and fewer side effects and abuse...
Eligibility Criteria
Inclusion
- 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
- age 18-75 years (inclusive)
- not using opioid analgesics on a daily basis or within 3 days of each laboratory session (confirmed via urine drug screen)
- Intact cognitive status and ability to provide informed consent
- ability to read and write in English sufficiently to understand and complete study questionnaires
Exclusion
- meet criteria for alcohol or substance abuse problems
- meet criteria for past or present psychotic or bipolar disorders
- inability to understand English well enough to complete questionnaires or participate in therapy
- pain due to malignant conditions, rheumatoid arthritis, migraine or tension headache, complex regional pain syndrome, or fibromyalgia syndrome
- lumbar surgery within past 6 months
- pregnant
- signs of nerve root compression (ie, positive straight-leg raise \<45○).
- liver diseases (e.g hepatitis or cirrhosis)
- suicide ideation with intent
- osteoporosis or bone demineralization
- opioid-dependency
- inability to hold breathe for 15 seconds
- acute trauma to spine
- long term use of corticosteroids
- spinal cord stimulator or IT pump inserted in back
- they have a BMI equal to or above 40
Key Trial Info
Start Date :
August 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04744883
Start Date
August 15 2020
End Date
June 1 2026
Last Update
July 10 2025
Active Locations (2)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212