Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06140355
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2023-11-07
Brief Title:
The HAPPINESS Trial cHAnging the Perceived Pain INtensity in divErSe Populations With Spinal Cord Injury
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
cHAnging the Perceived Pain INtensity in divErSe Populations With Spinal Cord Injury
Status:
RECRUITING
Status Verified Date:
2024-09
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 neuropathic pain affects 69 of adults with spinal cord injury SCI Current treatment options are limited primarily pain medications with insufficient benefits and significant risks for addiction and adverse effects Of the available mind and body approaches Qigong is the most accessible for adults with SCI with evidence for effectiveness in reducing pain but there is insufficient evidence to make recommendations for adults with SCI Thus the feasibility of Qigong in SCI needs to be established
To support our feasibility study we investigated a 12-week remote Qigong program in adults with SCI and neuropathic pain We recruited 23 adults with SCI 18 completed the study and 12 completed the 1-year follow-up They practiced Qigong 138 of the required intensity which was at least 3xweek with Qigong video through the internet Their pain was reduced by 44 after 12 weeks of Qigong practice and was still reduced at the 6-week and 1-year follow-up However three key elements need to be addressed before performing a larger effectiveness study 1 feasibilityacceptability of Qigong from adults with SCI of diverse backgrounds 2 feasibility of the study design with control group and 3 objective outcome measures
This R34 feasibility study the HAPPINESS trial cHAnging the Perceived Pain INtensity in divErSe populations with Spinal cord injury will expand on our prior study to consolidate feasibility with a rigorous protocol We will address the following aims AIM 1 Identify the facilitatorsbarriers to participating in a Qigong study through focus groupsinterviews with stakeholders from diverse backgrounds defined as Hispanics veterans and adults living in rural underserved areas AIM 2 Establish the feasibility of study designmethods of the HAPPINESS trial in adults with SCI at least 50 of diverse backgrounds through pre-specified targets for recruitmentenrollment feasibility and acceptability of design and outcomes Using a Phase I randomized controlled trial design 40 adults with SCI-related neuropathic pain will be randomized to 12-week remote Qigong intervention OR a short daily pain management survey that can be completed on phoneiPadcomputer 6-month follow-up The study results will facilitate a rigorous structure to design larger effectiveness studies and facilitate a clear pathway for researchers to investigate Qigong and other mind-body approaches for whole-person health in diverse groups of adults with chronicneurological disorders
To support our feasibility study we investigated a 12-week remote Qigong program in adults with SCI and neuropathic pain We recruited 23 adults with SCI 18 completed the study and 12 completed the 1-year follow-up They practiced Qigong 138 of the required intensity which was at least 3xweek with Qigong video through the internet Their pain was reduced by 44 after 12 weeks of Qigong practice and was still reduced at the 6-week and 1-year follow-up However three key elements need to be addressed before performing a larger effectiveness study 1 feasibilityacceptability of Qigong from adults with SCI of diverse backgrounds 2 feasibility of the study design with control group and 3 objective outcome measures
This R34 feasibility study the HAPPINESS trial cHAnging the Perceived Pain INtensity in divErSe populations with Spinal cord injury will expand on our prior study to consolidate feasibility with a rigorous protocol We will address the following aims AIM 1 Identify the facilitatorsbarriers to participating in a Qigong study through focus groupsinterviews with stakeholders from diverse backgrounds defined as Hispanics veterans and adults living in rural underserved areas AIM 2 Establish the feasibility of study designmethods of the HAPPINESS trial in adults with SCI at least 50 of diverse backgrounds through pre-specified targets for recruitmentenrollment feasibility and acceptability of design and outcomes Using a Phase I randomized controlled trial design 40 adults with SCI-related neuropathic pain will be randomized to 12-week remote Qigong intervention OR a short daily pain management survey that can be completed on phoneiPadcomputer 6-month follow-up The study results will facilitate a rigorous structure to design larger effectiveness studies and facilitate a clear pathway for researchers to investigate Qigong and other mind-body approaches for whole-person health in diverse groups of adults with chronicneurological disorders
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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