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Chronic Low-back PainEarly Phase 1NCT04744883

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

A Early Phase 1 study testing Spinal Manipulation Therapy (SMT), Naloxone and Mindfulness Based Stress Reduction Therapy (MT) in people with Chronic Low-back Pain, run by Rush University Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Low-back Pain
What is being tested?
Spinal Manipulation Therapy (SMT), Naloxone and Mindfulness Based Stress Reduction Therapy (MT)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
2 sitesUnited States
Study dates
15 Aug 2020to 28 Oct 2026
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • age 18-75 years (inclusive)
  • not using opioid analgesics on a daily basis or within 3 days of each laboratory session (confirmed via urine drug screen)
  • Intact cognitive status and ability to provide informed consent
  • ability to read and write in English sufficiently to understand and complete study questionnaires

Who cannot join

  • meet criteria for alcohol or substance abuse problems
  • meet criteria for past or present psychotic or bipolar disorders
  • inability to understand English well enough to complete questionnaires or participate in therapy
  • pain due to malignant conditions, rheumatoid arthritis, migraine or tension headache, complex regional pain syndrome, or fibromyalgia syndrome
  • lumbar surgery within past 6 months
  • pregnant
Show all 16Show fewer
  • signs of nerve root compression (ie, positive straight-leg raise <45○).
  • liver diseases (e.g hepatitis or cirrhosis)
  • suicide ideation with intent
  • osteoporosis or bone demineralization
  • opioid-dependency
  • inability to hold breathe for 15 seconds
  • acute trauma to spine
  • long term use of corticosteroids
  • spinal cord stimulator or IT pump inserted in back
  • they have a BMI equal to or above 40

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

Other trials in United States

About this study

Official title: Evaluating Specific and Non-Specific Mechanisms in Two Distinct Complementary/Integrative Interventions for Chronic Pain

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.

Read the 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.

Being tested
Spinal Manipulation Therapy (SMT), Naloxone, Placebo, Mindfulness Based Stress Reduction Therapy (MT)
Keywords
chronic low back pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal Manipulation Therapy (SMT)Other

    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.

  • NaloxoneDrug

    Also called narcan

    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

  • PlaceboDrug

    Also called normal saline 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

  • Mindfulness Based Stress Reduction Therapy (MT)Behavioural

    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.

Study groups in NCT04744883
Study groupRoleWhat they receive
SMT plus placebo/naloxoneExperimentalParticipants 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.
Receives: Other: Spinal Manipulation Therapy (SMT); Drug: Naloxone; Drug: Placebo
MT plus placebo/naloxoneExperimentalParticipants 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.
Receives: Drug: Naloxone; Drug: Placebo; Behavioral: Mindfulness Based Stress Reduction Therapy (MT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

    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.

    Measured: Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)

Secondary outcomes (4)

  1. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (Short Form)

    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.

    Measured: Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)

  2. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression

    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.

    Measured: Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)

  3. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form)

    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.

    Measured: Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)

  4. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance

    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.

    Measured: Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2021
  2. Study start15 Aug 2020
  3. Primary completion29 Nov 2024
  4. Study completion28 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04744883
Sponsor's protocol ID
17100503
Status last verified
Oct 2026
First submitted
19 Nov 2020
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK91497/

    PubMed 22553896

  • Boudreau D, Von Korff M, Rutter CM, Saunders K, Ray GT, Sullivan MD, Campbell CI, Merrill JO, Silverberg MJ, Banta-Green C, Weisner C. Trends in long-term opioid therapy for chronic non-cancer pain. Pharmacoepidemiol Drug Saf. 2009 Dec;18(12):1166-75. doi: 10.1002/pds.1833.

    PubMed 19718704

  • Kuehn BM. Opioid prescriptions soar: increase in legitimate use as well as abuse. JAMA. 2007 Jan 17;297(3):249-51. doi: 10.1001/jama.297.3.249. No abstract available.

    PubMed 17227967

  • Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.

    PubMed 22786464

  • Sullivan MD, Edlund MJ, Fan MY, DeVries A, Braden JB, Martin BC. Trends in use of opioids for non-cancer pain conditions 2000-2005 in commercial and Medicaid insurance plans: the TROUP study. Pain. 2008 Aug 31;138(2):440-449. doi: 10.1016/j.pain.2008.04.027. Epub 2008 Jun 10.

    PubMed 18547726

  • Rubinstein SM. Adverse events following chiropractic care for subjects with neck or low-back pain: do the benefits outweigh the risks? J Manipulative Physiol Ther. 2008 Jul-Aug;31(6):461-4. doi: 10.1016/j.jmpt.2008.06.001.

    PubMed 18722202

  • Chenot JF, Becker A, Leonhardt C, Keller S, Donner-Banzhoff N, Baum E, Pfingsten M, Hildebrandt J, Basler HD, Kochen MM. Use of complementary alternative medicine for low back pain consulting in general practice: a cohort study. BMC Complement Altern Med. 2007 Dec 18;7:42. doi: 10.1186/1472-6882-7-42.

    PubMed 18088435

  • Ruddock JK, Sallis H, Ness A, Perry RE. Spinal Manipulation Vs Sham Manipulation for Nonspecific Low Back Pain: A Systematic Review and Meta-analysis. J Chiropr Med. 2016 Sep;15(3):165-83. doi: 10.1016/j.jcm.2016.04.014. Epub 2016 May 25.

    PubMed 27660593

  • Yuan J, Purepong N, Kerr DP, Park J, Bradbury I, McDonough S. Effectiveness of acupuncture for low back pain: a systematic review. Spine (Phila Pa 1976). 2008 Nov 1;33(23):E887-900. doi: 10.1097/BRS.0b013e318186b276.

    PubMed 18978583

  • Cramer H, Haller H, Lauche R, Dobos G. Mindfulness-based stress reduction for low back pain. A systematic review. BMC Complement Altern Med. 2012 Sep 25;12:162. doi: 10.1186/1472-6882-12-162.

    PubMed 23009599

  • Lauche R, Cramer H, Dobos G, Langhorst J, Schmidt S. A systematic review and meta-analysis of mindfulness-based stress reduction for the fibromyalgia syndrome. J Psychosom Res. 2013 Dec;75(6):500-10. doi: 10.1016/j.jpsychores.2013.10.010. Epub 2013 Oct 26.

    PubMed 24290038

  • Veehof MM, Trompetter HR, Bohlmeijer ET, Schreurs KM. Acceptance- and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review. Cogn Behav Ther. 2016;45(1):5-31. doi: 10.1080/16506073.2015.1098724. Epub 2016 Jan 28.

    PubMed 26818413

  • Bawa FL, Mercer SW, Atherton RJ, Clague F, Keen A, Scott NW, Bond CM. Does mindfulness improve outcomes in patients with chronic pain? Systematic review and meta-analysis. Br J Gen Pract. 2015 Jun;65(635):e387-400. doi: 10.3399/bjgp15X685297.

    PubMed 26009534

  • Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. 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: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.

    PubMed 27002445

  • Omidi A, Zargar F. Effect of mindfulness-based stress reduction on pain severity and mindful awareness in patients with tension headache: a randomized controlled clinical trial. Nurs Midwifery Stud. 2014 Sep;3(3):e21136. doi: 10.17795/nmsjournal21136. Epub 2014 Sep 20.

    PubMed 25699282

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Spinal Manipulation Therapy (SMT), Naloxone and Mindfulness Based Stress Reduction Therapy (MT) in people with Chronic Low-back Pain, run by Rush University Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (time frame: Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04744883, which also lists 112 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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