Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546462
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2023-11-13
Brief Title:
Can a Specific OMT Protocol Influence Patient Pain and Associated Analgesia Use for Primary Headache Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Can a Specific OMT Protocol Influence Patient-reported Pain and Associated Analgesia Use for Primary Headache Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if osteopathic manipulation or light touch can reduce either or both frequency of headaches or use of pain medication Osteopathic manipulative treatment OMT has been shown to help headache symptoms The investigators like to see if regular OMT sessions can help reduce headache discomfort and also reduce use of pain medication like over-the-counter medications migraine medications and opioids In this randomized controlled trial a set sequence of OMT will be compared to light touch sham protocol Investigators will compare participant responses to questionnaires that assess items including pain levels and reported pain medication use for the course of the study period to see if there are any shifts
Detailed Description:
The purpose of this study is to evaluate the effectiveness of osteopathic manipulative treatment protocol OMT or light touch protocol in reducing headache frequency and the use of pain medication for headache pain Previous research has suggested that OMT may alleviate headache symptoms This randomized controlled trial aims to determine whether regular OMT sessions can decrease headache discomfort and reduce the use of pain medications including over-the-counter medications migraine-specific treatments and opioids The study consists of a ten-week period including 2 weeks of observation 6 weeks of intervention and 2 weeks of washout Participants will be randomly assigned to either receive OMT or a light touch protocol Investigators will compare questionnaires assessing quality of life and functionality scales Pain levels and medication use will be logged daily throughout the study
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