Ohio University
Athens, Ohio, 45701, United States
NCT Number: NCT06351774
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 (PT+HMI) aimed at cultivating awareness, connection, insight, and purpose for people with chronic low back pain (CLBP).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Athens, Ohio, 45701, United States
The overall objective is to primarily elucidate differential changes in CLBP patients administered PT or PT+HMI 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), i.e., responders to PT and PT+Well 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 PT+HMI 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Physical therapy for the treatment of chronic low back pain, as directed by a licensed Physical Therapist. The Healthy Minds Innovations (HMI) program is an app-based learning platform developed through the University of Wisconsin-Madison Center for Healthy Minds. The HMI app includes foundational meditation practices and short podcast-style lessons based on the science of wellbeing to cultivate mindfulness, positive relationships, and insight into the nature of the self.
Other names: Meditation
Time frame: Baseline (T0), mid-treatment/week 10 (T1), post-treatment/week 26 (T2), and post-treatment/week 52 (T3)
A self-reported outcome measure of back disability
Time frame: Baseline (T0), post-treatment/week 26 (T2), and post-treatment/week 52 (T3)
A self-reported outcome measure of pain interference
Time frame: Baseline (T0) and post-treatment/week 26 (T2)
Measure of physical activity levels for 10 days of home use
Time frame: Baseline (T0) and post-treatment/week 26 (T2)
Trunk motion capture during walking and lifting tasks
Time frame: Baseline (T0) and post-treatment/week 26 (T2)
Chronic Pain Acceptance Questionnaire (CPAQ-20)
Time frame: Baseline (T0) and post-treatment/week 26 (T2)
Committed Action Questionnaire (CAQ-8)
Time frame: Baseline (T0) and post-treatment/week 26 (T2)
Emotional Styles Questionnaire (ESQ)
Time frame: Baseline (T0), mid-treatment/week 10 (T1), post-treatment/week 26 (T2), and post-treatment/week 52 (T3)
Stanford Exercise Behavior Scale (SEBS)
Time frame: Baseline (T0)
Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-10)
Time frame: Baseline (T0)
Start Back Screening Tool (SBST-9)
Time frame: Baseline (T0)
Tampa Scale of Kinesiophobia (TSK-11)
Time frame: Baseline (T0)
Healthcare Experiences and Attitudes List - Attitudes Towards Complementary and Alternative Medicine (HEAL-CAM)
Time frame: Baseline (T0)
HEAL Treatment Expectancy (HEAL-TEX)
Time frame: Baseline (T0) and week 26 (T2)
Quantitative Sensory Testing
Time frame: Baseline (T0) and week 26 (T2)
Quantitative Sensory Testing
Ohio University
Other
An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain
Acronym: AdaPT
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