Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04744883
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2020-11-19
Brief Title:
Efficacy of Spinal Manipulation Therapy or Mindfulness-based Reduction Therapy on Patients With Chronic Low Back Pain
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Evaluating Specific and Non-Specific Mechanisms in Two Distinct ComplementaryIntegrative Interventions for Chronic Pain
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 betweenwithin-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
The study will employ a mixed betweenwithin-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None