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

Rush

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Chronic Low-back Pain

Treatments: Drug: Naloxone; Other: Spinal Manipulation Therapy (SMT); Behavioral: Mindfulness Based Stress Reduction Therapy (MT); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04744883

17100503

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

SMT plus placebo/naloxone

Experimental group

Description:

Participants are randomly assigned to an 8 week SMT treatment group conducted by certified physical therapists. Immediately before and after the treatment sessions along with midway through the treatment (after 4 sessions), participants will undergo the placebo/naloxone administration intervention to assess mechanisms of SMT or MT-related changes.

Treatment:

Drug: Placebo

Other: Spinal Manipulation Therapy (SMT)

Drug: Naloxone

MT plus placebo/naloxone

Experimental group

Description:

Participants are randomly assigned to an 8 week MT treatment group conducted by certified clinical therapists. Immediately before and after the treatment sessions along with midway through the treatment (after 4 sessions), participants will undergo the placebo/naloxone administration intervention to assess mechanisms of SMT or MT-related changes.

Treatment:

Drug: Placebo

Behavioral: Mindfulness Based Stress Reduction Therapy (MT)

Drug: Naloxone