Clinical trial NCT04744883: Efficacy of Spinal Manipulation Therapy or Mindfulness-based Reduction Therapy on Patients With Chronic Low Back Pain
Official title: Evaluating Specific and Non-Specific Mechanisms in Two Distinct Complementary/Integrative Interventions for Chronic Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Chronic Low-back Pain
Keywords: chronic low back pain
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
First posted: 2021-02-09
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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-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 4 laboratory pain-induction sessions in total. 2 during the pre-treatment phase, and 2 post-treatment. The laboratory sessions are identical. 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.

Eligibility 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

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (Short Form)
timeFrame: Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression
timeFrame: Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form)
timeFrame: Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance
timeFrame: Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Rush University Medical Center
name: John Burns, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Stephen Bruehl, PhD
role: PRINCIPAL_INVESTIGATOR
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