Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain
- Conditions
- Back Pain Lower Back ChronicDisability Physical
- Interventions
- Behavioral: Physical therapy
- Registration Number
- NCT06351774
- Lead Sponsor
- Ohio University
- 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 (PT+HMI) 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- A minimum age of at least 18 years; the ability to read and speak English; have visited a health care professional for back pain during the past 90 days with a physician referral for PT; have experienced back pain for at least 3 months duration and for at least ½ days in the past 6 months; and currently experiencing at least moderate back-related disability, which was operationalized as a score of ≥24% (12 out of 50 points) on the Oswestry Disability Index (ODI). Participants needed to have smart device access to engage with the HMI app.
- Having undergone lumbar surgery within the past year; an ongoing disability or worker's compensation, or legal claim; informed by their physician the presence of a serious pathology causing their LBP; pregnancy or planning to become pregnant; and having previously received PT for LBP during the prior 6 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description PT Physical therapy Participants will receive physiotherapy per clinical practice guideline recommendations for 8 weeks (Phase 1). At week 10, participants will complete the Oswestry Disability Index (ODI) to determine their response to treatment. Individuals who report a favorable response to PT, defined by a threshold of improvement of at least 30% in their ODI, will continue with their PT for an additional 8 weeks. Individuals who do not favorably respond to PT will receive the Healthy Minds Innovation (HMI) app for an additional 8 weeks (Phase 2). PT+HMI Physical therapy Participants will receive physiotherapy per clinical practice guideline recommendations for 8 weeks, in addition to the Healthy Minds Innovation app (Phase 1). At week 10, participants will complete the Oswestry Disability Index (ODI) to determine their response to treatment. Individuals who report a favorable response to PT+HMI, defined by a threshold of improvement of at least 30% in their ODI, will continue with their PT+HMI for an additional 8 weeks. Individuals who do not favorably respond to PT+HMI will receive an in-person teacher-guided tai chi session and tai chi videos for guided self-practice for an additional 8 weeks (Phase 2).
- Primary Outcome Measures
Name Time Method Oswestry Disability Index 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
PROMIS Pain Interference Baseline (T0), post-treatment/week 26 (T2), and post-treatment/week 52 (T3) A self-reported outcome measure of pain interference
- Secondary Outcome Measures
Name Time Method Exercise behavior Baseline (T0), mid-treatment/week 10 (T1), post-treatment/week 26 (T2), and post-treatment/week 52 (T3) Stanford Exercise Behavior Scale (SEBS)
Kinesiophobia Baseline (T0) Tampa Scale of Kinesiophobia (TSK-11)
Actigraphy Baseline (T0) and post-treatment/week 26 (T2) Measure of physical activity levels for 10 days of home use
3D Motion Capture Baseline (T0) and post-treatment/week 26 (T2) Trunk motion capture during walking and lifting tasks
Committed action Baseline (T0) and post-treatment/week 26 (T2) Committed Action Questionnaire (CAQ-8)
Back pain screening tool 1 Baseline (T0) Start Back Screening Tool (SBST-9)
Treatment expectancy Baseline (T0) HEAL Treatment Expectancy (HEAL-TEX)
Pain acceptance Baseline (T0) and post-treatment/week 26 (T2) Chronic Pain Acceptance Questionnaire (CPAQ-20)
Healthy emotionality Baseline (T0) and post-treatment/week 26 (T2) Emotional Styles Questionnaire (ESQ)
Attitudes towards complementary and alternative medicine Baseline (T0) Healthcare Experiences and Attitudes List - Attitudes Towards Complementary and Alternative Medicine (HEAL-CAM)
Lumbar pressure pain threshold Baseline (T0) and week 26 (T2) Quantitative Sensory Testing
Thermal method of limits Baseline (T0) and week 26 (T2) Quantitative Sensory Testing
Trial Locations
- Locations (1)
Ohio University
🇺🇸Athens, Ohio, United States