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

  • STATUS
    Recruiting
  • End date
    Jul 17, 2023
  • participants needed
    240
  • sponsor
    Rush University Medical Center
Updated on 17 February 2021

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.

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-relevant drug effects. This X year project will test study hypotheses in a sample of 240 chronic low back pain patients. The study will have 2 key elements: 1) a randomized, controlled SMT or MT in chronic pain (CP) patients completing daily take home exercises and 2) laboratory evoked thermal pain protocols pre- and post- therapy, permitting the quantification of EO function and the examining of treatment-induced changes in EO function (placebo vs. naloxone).

The study will employ a mixed between/within-subjects design using double-blinded and placebo-controlled administration of the opioid antagonist (naloxone). The study will use a 8 week supervised MT or SMT manipulation with subjects randomly assigned to one of the groups. All participants will undergo 6 laboratory pain-induction sessions in total. 2 during the pre-treatment phase, 2 during the mid-treatment phase, and 2 post-treatment. The laboratory sessions are identical with the exception of one of the 2 mid-treatment laboratory sessions, where extra questionnaires are administered. Each laboratory session will be roughly 2-3 days apart and the first 2 laboratory sessions will occur prior to the randomization to the treatment condition.

Details
Condition Chronic Low Back Pain, Chronic Lower Back Pain
Treatment Placebo, naloxone, Spinal Manipulation Therapy (SMT), Mindfulness Based Stress Reduction Therapy (MT)
Clinical Study IdentifierNCT04744883
SponsorRush University Medical Center
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

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
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
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