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| Name | Class |
|---|---|
| Vanderbilt University Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMT plus placebo/naloxone | Experimental | 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. |
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| MT plus placebo/naloxone | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks) |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Burns, PhD | Rush University Medical Center | Principal Investigator |
| Stephen Bruehl, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States | ||
| Vanderbilt University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22553896 | Background | 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/ | |
| 19718704 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2024 | Sep 16, 2024 |
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| Naloxone | Drug | 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 |
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| Placebo | Drug | 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 |
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| Mindfulness Based Stress Reduction Therapy (MT) | Behavioral | 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. |
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| 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. | Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks) |
| 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. | Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks) |
| 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. | Baseline, after each weekly treatment session, 3- and 6-month follow-up (roughly 16 weeks) |
| Nashville |
| Tennessee |
| 37212 |
| United States |
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| 21862829 | Background | Bruehl S, Burns JW, Chung OY, Chont M. Interacting effects of trait anger and acute anger arousal on pain: the role of endogenous opioids. Psychosom Med. 2011 Sep;73(7):612-9. doi: 10.1097/PSY.0b013e318227cb88. Epub 2011 Aug 23. |
| 18377139 | Background | Bruehl S, Burns JW, Chung OY, Quartana P. Anger management style and emotional reactivity to noxious stimuli among chronic pain patients and healthy controls: the role of endogenous opioids. Health Psychol. 2008 Mar;27(2):204-14. doi: 10.1037/0278-6133.27.2.204. |
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| Prot_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 25, 2024 | May 14, 2024 | ICF_003.pdf |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided