Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142597
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2005-09-01
Brief Title:
Effectiveness of Acupuncture in Relieving Pain Due to Fibromyalgia
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Mechanisms of Acupuncture Analgesia
Status:
COMPLETED
Status Verified Date:
2014-12
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:
This study will determine the effectiveness of acupuncture versus a placebo in altering brain activity and relieving pain due to fibromyalgia
Detailed Description:
Fibromyalgia is one of the most common rheumatic diseases second only to osteoarthritis It causes chronic muscle pain and fatigue Acupuncture functions by targeting specific nerve pathways to different organs or parts of the body Research has shown that acupuncture is effective in decreasing or eliminating peoples sensitivity to pain in targeted regions However some believe that the reduction in pain is due to a placebo response rather than acupuncture itself This study will use two brain-imaging techniques to determine the brain response to acupuncture versus a simulation of acupuncture thereby assessing whether acupuncture is actually effective in relieving pain
Participants in this single-blind study will be randomly assigned to receive either acupuncture or a placebo treatment The placebo will consist of a simulation of acupuncture Functional magnetic resonance imaging fMRI and positron emission tomography PET will be used to assess activity of brain mu-opioid receptors These receptors are involved in the bodys ability to perceive pain All participants will be scanned twice using the fMRI scanner once before any treatment sessions and once at the conclusion of all treatment sessions Both fMRI sessions will involve applying pressure to the thumb to elicit a response in the brain in order to assess the corresponding fMRI blood oxygen level dependent BOLD signal and whether this activation changes after treatment intervention Participants will then receive nine treatments of acupuncture or placebo outside the scanner over a 4-week period The PET portion of this study is optional and if you elect to participate your first treatment session will be performed in the PET scanner After this first session participants will have seven additional treatment sessions outside of the scanner over a 4-week period The last session will be performed in the PET scanner to assess changes in mu-opioid receptor activity that may have occurred over the 4 weeks A baseline visit to determine eligibility and a close-out visit at week 8 are also part of the participation schedule It is very important that participants live within driving distance of Ann Arbor MI due to the significant number of visits to our Center
Participants in this single-blind study will be randomly assigned to receive either acupuncture or a placebo treatment The placebo will consist of a simulation of acupuncture Functional magnetic resonance imaging fMRI and positron emission tomography PET will be used to assess activity of brain mu-opioid receptors These receptors are involved in the bodys ability to perceive pain All participants will be scanned twice using the fMRI scanner once before any treatment sessions and once at the conclusion of all treatment sessions Both fMRI sessions will involve applying pressure to the thumb to elicit a response in the brain in order to assess the corresponding fMRI blood oxygen level dependent BOLD signal and whether this activation changes after treatment intervention Participants will then receive nine treatments of acupuncture or placebo outside the scanner over a 4-week period The PET portion of this study is optional and if you elect to participate your first treatment session will be performed in the PET scanner After this first session participants will have seven additional treatment sessions outside of the scanner over a 4-week period The last session will be performed in the PET scanner to assess changes in mu-opioid receptor activity that may have occurred over the 4 weeks A baseline visit to determine eligibility and a close-out visit at week 8 are also part of the participation schedule It is very important that participants live within driving distance of Ann Arbor MI due to the significant number of visits to our Center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K01AT001111-01 | NIH | None | httpsreporternihgovquickSearch1K01AT001111-01 |
| K01AT001111-01 | NIH | None | None |