Efficacy of Spinal Manipulation Therapy or Mindfulness-based Reduction Therapy on Patients With C… (NCT04744883) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Efficacy of Spinal Manipulation Therapy or Mindfulness-based Reduction Therapy on Patients With Chronic Low Back Pain
United States140 participantsStarted 2020-08-15
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Timeframe: Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)