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

NCT04744883

EARLY_PHASE1INTERVENTIONAL

Rush University Medical Center

140 participants

Started 2020-08-15 · Completed 2026-06-01

Status: Active Not Recruiting (as of 12-23-2025)

Conditions

Chronic Low-back Pain

Interventions

OTHER: Spinal Manipulation Therapy (SMT)DRUG: Naloxone DRUG: Placebo BEHAVIORAL: Mindfulness Based Stress Reduction Therapy (MT)

Linked Papers (from SciSciNet-V2)

Total Papers102

Background

39

Result

0

Derived

0

Unknown

63

View on ClinicalTrials.gov

Total Citations Per Year

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.

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Background Papers77

Chapter 4 European guidelines for the management of chronic nonspecific low back pain

2,387 citations

Chapter 4 European guidelines for the management of chronic nonspecific low back pain

2,387 citations

An updated overview of clinical guidelines for the management of non-specific low back pain in primary care

1,191 citations

An updated overview of clinical guidelines for the management of non-specific low back pain in primary care

1,191 citations

Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome

1,096 citations

Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome

1,096 citations

The mechanisms of manual therapy in the treatment of musculoskeletal pain: A comprehensive model

The mechanisms of manual therapy in the treatment of musculoskeletal pain: A comprehensive model

Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain

Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain

Brain Mechanisms Supporting the Modulation of Pain by Mindfulness Meditation

Brain Mechanisms Supporting the Modulation of Pain by Mindfulness Meditation

Placebo effects on human μ-opioid activity during pain

Placebo effects on human μ-opioid activity during pain

Trends in long‐term opioid therapy for chronic non‐cancer pain

Trends in long‐term opioid therapy for chronic non‐cancer pain

United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care

Trends in use of opioids for non-cancer pain conditions 2000–2005 in Commercial and Medicaid insurance plans: The TROUP study

Trends in use of opioids for non-cancer pain conditions 2000–2005 in Commercial and Medicaid insurance plans: The TROUP study

Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on μ-opioid receptors (MORs)

Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on μ-opioid receptors (MORs)

Mindfulness-based stress reduction and cognitive behavioral therapy for chronic low back pain: similar effects on mindfulness, catastrophizing, self-efficacy, and acceptance in a randomized controlled trial

Mindfulness-based stress reduction and cognitive behavioral therapy for chronic low back pain: similar effects on mindfulness, catastrophizing, self-efficacy, and acceptance in a randomized controlled trial

Osteopathic manipulative treatment for nonspecific low back pain: a systematic review and meta-analysis

Osteopathic manipulative treatment for nonspecific low back pain: a systematic review and meta-analysis

Mindfulness-based stress reduction for low back pain. A systematic review

Mindfulness-based stress reduction for low back pain. A systematic review

Does mindfulness improve outcomes in patients with chronic pain? Systematic review and meta-analysis

Does mindfulness improve outcomes in patients with chronic pain? Systematic review and meta-analysis

Spinal Manipulative Therapy Has an Immediate Effect on Thermal Pain Sensitivity in People With Low Back Pain: A Randomized Controlled Trial

Spinal Manipulative Therapy Has an Immediate Effect on Thermal Pain Sensitivity in People With Low Back Pain: A Randomized Controlled Trial

Immediate effects of spinal manipulation on thermal pain sensitivity: an experimental study

Immediate effects of spinal manipulation on thermal pain sensitivity: an experimental study

Complementary and alternative medical therapies for chronic low back pain: What treatments are patients willing to try?

Complementary and alternative medical therapies for chronic low back pain: What treatments are patients willing to try?

Spinal Manipulative Therapy–Specific Changes in Pain Sensitivity in Individuals With Low Back Pain (NCT01168999)

Spinal Manipulative Therapy–Specific Changes in Pain Sensitivity in Individuals With Low Back Pain (NCT01168999)

Mindfulness-Meditation-Based Pain Relief Is Not Mediated by Endogenous Opioids

Mindfulness-Meditation-Based Pain Relief Is Not Mediated by Endogenous Opioids

Randomized trial of group cognitive behavioral therapy compared with a pain education control for low-literacy rural people with chronic pain

Randomized trial of group cognitive behavioral therapy compared with a pain education control for low-literacy rural people with chronic pain

Preliminary Investigation of the Mechanisms Underlying the Effects of Manipulation

Preliminary Investigation of the Mechanisms Underlying the Effects of Manipulation

Dose-response and efficacy of spinal manipulation for care of chronic low back pain: a randomized controlled trial

Dose-response and efficacy of spinal manipulation for care of chronic low back pain: a randomized controlled trial

Is reduction in pain catastrophizing a therapeutic mechanism specific to cognitive-behavioral therapy for chronic pain?

Is reduction in pain catastrophizing a therapeutic mechanism specific to cognitive-behavioral therapy for chronic pain?

Immediate reduction in temporal sensory summation after thoracic spinal manipulation

Immediate reduction in temporal sensory summation after thoracic spinal manipulation

Effect of Mindfulness-Based Stress Reduction on Pain Severity and Mindful Awareness in Patients With Tension Headache: A Randomized Controlled Clinical Trial

Effect of Mindfulness-Based Stress Reduction on Pain Severity and Mindful Awareness in Patients With Tension Headache: A Randomized Controlled Clinical Trial

Use of complementary alternative medicine for low back pain consulting in general practice: a cohort study

Use of complementary alternative medicine for low back pain consulting in general practice: a cohort study

Spinal Manipulation Vs Sham Manipulation for Nonspecific Low Back Pain: A Systematic Review and Meta-analysis

Spinal Manipulation Vs Sham Manipulation for Nonspecific Low Back Pain: A Systematic Review and Meta-analysis

Short-term test-retest-reliability of conditioned pain modulation using the cold-heat-pain method in healthy subjects and its correlation to parameters of standardized quantitative sensory testing

Short-term test-retest-reliability of conditioned pain modulation using the cold-heat-pain method in healthy subjects and its correlation to parameters of standardized quantitative sensory testing

Basis for spinal manipulative therapy: A physical therapist perspective

Basis for spinal manipulative therapy: A physical therapist perspective

Endogenous opioid function mediates the association between laboratory-evoked pain sensitivity and morphine analgesic responses

Endogenous opioid function mediates the association between laboratory-evoked pain sensitivity and morphine analgesic responses

Does Exercise Decrease Pain via Conditioned Pain Modulation in Adolescents?

Does Exercise Decrease Pain via Conditioned Pain Modulation in Adolescents?

Association of lumbar spine stiffness and flexion-relaxation phenomenon with patient-reported outcomes in adults with chronic low back pain – a single-arm clinical trial investigating the effects of thrust spinal manipulation

Association of lumbar spine stiffness and flexion-relaxation phenomenon with patient-reported outcomes in adults with chronic low back pain – a single-arm clinical trial investigating the effects of thrust spinal manipulation

Psychosocial factors predict opioid analgesia through endogenous opioid function

Psychosocial factors predict opioid analgesia through endogenous opioid function

Interacting Effects of Trait Anger and Acute Anger Arousal on Pain

Endogenous opioids may buffer effects of anger arousal on sensitivity to subsequent pain

Endogenous opioids may buffer effects of anger arousal on sensitivity to subsequent pain

Interacting Effects of Trait Anger and Acute Anger Arousal on Pain

Endogenous Opioid Inhibition of Chronic Low-Back Pain Influences Degree of Back Pain Relief After Morphine Administration

Endogenous Opioid Inhibition of Chronic Low-Back Pain Influences Degree of Back Pain Relief After Morphine Administration

Anger Management Style Moderates Effects of Attention Strategy During Acute Pain Induction on Physiological Responses to Subsequent Mental Stress and Recovery: A Comparison of Chronic Pain Patients and Healthy Nonpatients

Anger Management Style Moderates Effects of Attention Strategy During Acute Pain Induction on Physiological Responses to Subsequent Mental Stress and Recovery: A Comparison of Chronic Pain Patients and Healthy Nonpatients

The effect of manual therapy with augmentative exercises for neck pain: a randomised clinical trial

The effect of manual therapy with augmentative exercises for neck pain: a randomised clinical trial

Result Papers0

No result papers linked

Derived Papers0

No derived papers linked

Unknown Papers63

The short-form McGill pain questionnaire

4,176 citations

Construct Validity of the Five Facet Mindfulness Questionnaire in Meditating and Nonmeditating Samples

2,597 citations

Mediators and Mechanisms of Change in Psychotherapy Research

2,232 citations

The pain self‐efficacy questionnaire: Taking pain into account

1,359 citations

Opioid Epidemic in the United States

1,121 citations

Nonpharmacologic Therapies for Acute and Chronic Low Back Pain: A Review of the Evidence for an American Pain Society/American College of Physicians Clinical Practice Guideline

1,003 citations

A Clinical Prediction Rule To Identify Patients with Low Back Pain Most Likely To Benefit from Spinal Manipulation: A Validation Study

Acceptance-based interventions for the treatment of chronic pain: A systematic review and meta-analysis

Distraction modulates connectivity of the cingulo-frontal cortex and the midbrain during pain—an fMRI analysis

A Clinical Prediction Rule for Classifying Patients with Low Back Pain Who Demonstrate Short-Term Improvement With Spinal Manipulation

Acceptance- and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review

Analgesia Following Exercise

Weekly Change in Mindfulness and Perceived Stress in a Mindfulness‐Based Stress Reduction Program

Expanding the lens of evidence-based practice in psychotherapy: A common factors perspective.

Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines

Opioid Prescriptions Soar

Treating fibromyalgia with mindfulness-based stress reduction: Results from a 3-armed randomized controlled trial☆

A systematic review and meta-analysis of mindfulness-based stress reduction for the fibromyalgia syndrome

Patterns and Perceptions of Care for Treatment of Back and Neck Pain

Do changes in cognitive factors influence outcome following multidisciplinary treatment for chronic pain? A cross-lagged panel analysis.

Spinal manipulative therapy for chronic low-back pain

Determining anatomical connectivities between cortical and brainstem pain processing regions in humans: A diffusion tensor imaging study in healthy controls

Mechanisms and effects of spinal high-velocity, low-amplitude thrust manipulation: Previous theories

Effectiveness of Acupuncture for Low Back Pain

Cognitive factors influence outcome following multidisciplinary chronic pain treatment: a replication and extension of a cross-lagged panel analysis

Biomechanics of spinal manipulative therapy

Personal Values and Pain Tolerance: Does a Values Intervention Add to Acceptance?

Anger and pain sensitivity in chronic low back pain patients and pain-free controls: the role of endogenous opioids

Epidemiology: Spinal manipulation utilization

Practice, practitioner, or placebo? A multifactorial, mixed-methods randomized controlled trial of acupuncture

Mindfulness-based Cognitive Therapy for the Treatment of Headache Pain

Spinal manipulation and beta-endorphin: a controlled study of the effect of a spinal manipulation on plasma beta-endorphin levels in normal males.

Joint Mobilization Enhances Mechanisms of Conditioned Pain Modulation in Individuals With Osteoarthritis of the Knee

The Effective Forces Transmitted by High-Speed, Low-Amplitude Thoracic Manipulation

Pain inhibits pain; human brainstem mechanisms

Imaging Human Cerebral Pain Modulation by Dose-dependent Opioid Analgesia

Cognitive and physical capacity process variables predict long-term outcome after treatment of chronic pain.

Effects of naloxone on dental pain threshold following muscle exercise and low frequency transcutaneous nerve stimulation: a comparative study in man

Can we improve cognitive–behavioral therapy for chronic back pain treatment engagement and adherence? A controlled trial of tailored versus standard therapy.

The Use of a Lumbar Spine Manipulation Technique by Physical Therapists in Patients Who Satisfy a Clinical Prediction Rule: A Case Series

Do Participants With Low Back Pain Who Respond to Spinal Manipulative Therapy Differ Biomechanically From Nonresponders, Untreated Controls or Asymptomatic Controls?

Specific and general therapeutic mechanisms in cognitive behavioral treatment of chronic pain.

The basis for spinal manipulation: Chiropractic perspective of indications and theory

Anger management style, blood pressure reactivity, and acute pain sensitivity: Evidence for “trait × situation” models

Adverse Events Following Chiropractic Care for Subjects With Neck or Low-Back Pain: Do The Benefits Outweigh the Risks?

The association between anger expression and chronic pain intensity: evidence for partial mediation by endogenous opioid dysfunction

Effect of Types and Anatomic Arrangement of Painful Stimuli on Conditioned Pain Modulation

Psychological response in spinal manipulation (PRISM): A systematic review of psychological outcomes in randomised controlled trials

Opioids and Pain Regulation

A new version of the ischemic tourniquet pain test.

Relaxation training and opioid inhibition of blood pressure response to stress.

Mindfulness Meditation Modulates Pain Through Endogenous Opioids

Within- and between-day reliability of spinal stiffness measurements obtained using a computer controlled mechanical indenter in individuals with and without low back pain

The effects of long- and short-term interdisciplinary treatment approaches in women with fibromyalgia: a randomized controlled trial

Opioid involvement in the perception of pain due to endurance exercise in trained man.

Outcomes of Acute and Chronic Patients With Magnetic Resonance Imaging–Confirmed Symptomatic Lumbar Disc Herniations Receiving High-Velocity, Low-Amplitude, Spinal Manipulative Therapy: A Prospective Observational Cohort Study With One-Year Follow-Up

Parental history of chronic pain may be associated with impairments in endogenous opioid analgesic systems

Interaction of Diazepam and Naloxone on Acupuncture Induced Pain Relief

Anger management style and emotional reactivity to noxious stimuli among chronic pain patients and healthy controls: The role of endogenous opioids.

INFLUENCE OF NALOXONE ON ELECTRO-ACUPUNCTURE ANALGESIA USING AN EXPERIMENTAL DENTAL PAIN TEST, REVIEW OF POSSIBLE MECHANISMS OF ACTION

Trait anger and blood pressure recovery following acute pain: Evidence for opioid-mediated effects