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

Early Phase 1

Active, not recruiting

• Conditions: Chronic Low-back Pain
• Interventions: Other: Spinal Manipulation Therapy (SMT); Drug: Placebo; Drug: Naloxone; Behavioral: Mindfulness Based Stress Reduction Therapy (MT)

• Registration Number: NCT04744883
• Lead Sponsor: Rush University Medical Center

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.

Study Timeline

• Study Start: 2020-08-15
• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-09
• Primary Completion: 2024-11-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MT plus placebo/naloxone	Placebo	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.
MT plus placebo/naloxone	Mindfulness Based Stress Reduction Therapy (MT)	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.
SMT plus placebo/naloxone	Spinal Manipulation Therapy (SMT)	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.
SMT plus placebo/naloxone	Placebo	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.
SMT plus placebo/naloxone	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.
MT plus placebo/naloxone	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (2)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States