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

Sponsor
Rush University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04744883
Collaborator
Vanderbilt University Medical Center (Other)
240
Enrollment
2
Locations
2
Arms
34.7
Anticipated Duration (Months)
120
Patients Per Site
3.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Spinal Manipulation Therapy (SMT)
  • Drug: Naloxone
  • Drug: Placebo
  • Behavioral: Mindfulness Based Stress Reduction Therapy (MT)
 Early Phase 1

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluating Specific and Non-Specific Mechanisms in Two Distinct Complementary/Integrative Interventions for Chronic Pain
Actual Study Start Date :
Aug 10, 2020
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: SMT plus placebo/naloxone

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.

Other: Spinal Manipulation Therapy (SMT)
2 SMT techniques are administered each session, both of which are scripted interactions between the physical therapist (PT) providing the SMT and the subjects: 1) Participants will lie on the SMT table for 20 mins, while the PT sits approximately 6 ft away. As part of the script, the PT will review with subjects the inclusion/exclusion criteria ostensibly to ensure that nothing has changed. 2) The PT will perform the 2 SMT techniques during the next 20 mins. 3) Subjects will sit upright in a chair for the remaining 20 mins, while the PT sits approximately 6 feet away. The PT will review home exercises with participant.

Drug: Naloxone
In randomized order (crossover) across 2 laboratory sessions each approximately 3 days apart, participants will receive either 1) 2 doses of saline placebo (20ml each) or 2) weight-adjusted doses of Naloxone beginning with a dose of 0.11mg/kg followed by a weight-adjusted dose of 0.055 mg/kg
Other Names:
  • narcan

    • Drug: Placebo
    In randomized order (crossover) across 2 laboratory sessions each approximately 3 days apart, participants will receive either 1) 2 doses of saline placebo (20ml each) or 2) weight-adjusted doses of Naloxone beginning with a dose of 0.11mg/kg followed by a weight-adjusted dose of 0.055 mg/kg
    Other Names:
  • normal saline placebo

    		•
    Experimental: MT plus placebo/naloxone

    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.

    Drug: Naloxone
    In randomized order (crossover) across 2 laboratory sessions each approximately 3 days apart, participants will receive either 1) 2 doses of saline placebo (20ml each) or 2) weight-adjusted doses of Naloxone beginning with a dose of 0.11mg/kg followed by a weight-adjusted dose of 0.055 mg/kg
    Other Names:
  • narcan

    • Drug: Placebo
    In randomized order (crossover) across 2 laboratory sessions each approximately 3 days apart, participants will receive either 1) 2 doses of saline placebo (20ml each) or 2) weight-adjusted doses of Naloxone beginning with a dose of 0.11mg/kg followed by a weight-adjusted dose of 0.055 mg/kg
    Other Names:
  • normal saline placebo

    • Behavioral: Mindfulness Based Stress Reduction Therapy (MT)
    Each MT session consists of (a) body scan meditation accompanied by awareness of breathing and other bodily sensations while in a lying position, (b) sitting meditation, focusing on awareness of breathing, bodily sensations, thoughts, and emotions (c) gentle movement exercises intended to develop awareness (mindfulness) during movement. In-session activities include suggestions for application of mindfulness as a method for responding positively to stress; dealing with the challenges of pain; and exercises focusing on the challenges and achievements patients experience in integrating mindfulness into their lives and the stressful situations they encounter. Additional discussion will focus on stress reactivity and they will be taught problem-solving skills to develop solutions to meet MT goals. Finally, patients will develop a written maintenance plan that includes a list of short- and long-term goals for applying mindfulness methods and a plan for dealing with possible setbacks.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference [Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)]

      Interference in daily activities attributed to chronic pain as reported by subjects. The PROMIS Pain Interference scale consists of 8 questions with a 5-point response scale ranging from Not at all - Very much. Participants are asked how much in the past 7 days everyday activities were affected by their pain. Higher scores indicate more pain interference in daily activities.

    Secondary Outcome Measures

    1. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (Short Form) [Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)]

      Intensity of chronic pain reported by subject. The PROMIS Pain Intensity scale consists of 3 questions with a 5-point response scale ranging from Had no pain - Very severe. Participants are asked how intense their pain has been in the past 7 days. Higher scores indicate more intense pain.

    2. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression [Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)]

      Degree of depressive symptoms reported by subject. The PROMIS Depression scale consists of 8 questions with a 5-point response scale ranging from Never - Always. Participants are asked how often they felt depressive emotions in the past 7 days. Higher scores indicate more depressive emotions.

    3. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form) [Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)]

      Amount of physical activity reported by subject. The PROMIS Physical Function scale consists of 27 questions with a 5-point response scale ranging from Without any difficulty - Unable to do. Participants are asked how much their pain affects their physical functioning. Higher scores indicate more inability to perform specific physical activities due to pain.

    4. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance [Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)]

      Degree of sleep disturbance reported by subject. The PROMIS Sleep Disturbance scale consists of 8 questions with a 5-point response scale ranging from Not at all - Very much. Participants are asked how much in the past 7 days their pain interfered with their sleep. Higher scores indicate more sleep disruptions.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rush University Medical Center Chicago Illinois United States 60612
    2 Vanderbilt University Medical Center Nashville Tennessee United States 37212

    Sponsors and Collaborators

    • Rush University Medical Center
    • Vanderbilt University Medical Center

    Investigators

    • Principal Investigator: John Burns, PhD, Rush University Medical Center
    • Principal Investigator: Stephen Bruehl, PhD, Vanderbilt University Medical Center

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Rush University Medical Center
    ClinicalTrials.gov Identifier:
    NCT04744883
    Other Study ID Numbers:
    • 17100503
    First Posted:
    Feb 9, 2021
    Last Update Posted:
    Feb 9, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rush University Medical Center
    chronic low back pain
    Additional relevant MeSH terms:
    Back Pain
    Low Back Pain
    Naloxone

    Study Results

    No Results Posted as of Feb 9, 2021