Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351774
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2024-04-02
Brief Title:
Project AdaPT An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain
Sponsor:
Ohio University
Organization:
Ohio University
Study Overview
Official Title:
An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain
Status:
COMPLETED
Status Verified Date:
2024-04
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:
AdaPT
Brief Summary:
In the proposed research we will elucidate the comparative effectiveness of standalone physiotherapy PT vs PT augmented with a self-guided app-based Healthy Minds Innovation wellbeing program PTHMI aimed at cultivating awareness connection insight and purpose for people with chronic low back pain CLBP
Detailed Description:
The overall objective is to primarily elucidate differential changes in CLBP patients administered PT or PTHMI across physical health domains back disability pain interference actigraphy gait performance Secondarily we will elucidate changes in patient-reported physical health outcomes for early non-responders who go on to receive an adaptive intervention that provides augmented treatment pathways
Our central hypothesis is that improvements in disability primary outcome ie responders to PT and PTWell will be differentially associated with changes in physical activity levels gait kinematics psychological flexibility and fear-avoidance We further predict that initial non-responders who progress to augmented care will show improvements in the primary outcomes We will conduct a two-armed RCT with 20 CLBP participants who will receive PT or PTHMI and test our hypotheses in 3 specific aims In Aim 1 we will use patient-reported measures of disability and pain interference to elucidate subjective physical health outcomes In Aim 2 we will use actigraphy to measure physical activity levels 3D trunk kinematic measures during gait and a lifting task to reveal movement-based responders In Aim 3 we will use patient-reported measures for indices of psychological flexibility and healthy emotionality to elucidate mental health processes that correlate with physical health outcomes
Our central hypothesis is that improvements in disability primary outcome ie responders to PT and PTWell will be differentially associated with changes in physical activity levels gait kinematics psychological flexibility and fear-avoidance We further predict that initial non-responders who progress to augmented care will show improvements in the primary outcomes We will conduct a two-armed RCT with 20 CLBP participants who will receive PT or PTHMI and test our hypotheses in 3 specific aims In Aim 1 we will use patient-reported measures of disability and pain interference to elucidate subjective physical health outcomes In Aim 2 we will use actigraphy to measure physical activity levels 3D trunk kinematic measures during gait and a lifting task to reveal movement-based responders In Aim 3 we will use patient-reported measures for indices of psychological flexibility and healthy emotionality to elucidate mental health processes that correlate with physical health outcomes
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