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| Name | Class |
|---|---|
| University of Wisconsin, Madison | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PT | Experimental | 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). |
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| PT+HMI | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index | A self-reported outcome measure of back disability | Baseline (T0), mid-treatment/week 10 (T1), post-treatment/week 26 (T2), and post-treatment/week 52 (T3) |
| PROMIS Pain Interference | A self-reported outcome measure of pain interference | Baseline (T0), post-treatment/week 26 (T2), and post-treatment/week 52 (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| Actigraphy | Measure of physical activity levels for 10 days of home use | Baseline (T0) and post-treatment/week 26 (T2) |
| 3D Motion Capture | Trunk motion capture during walking and lifting tasks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas V Karayannis, MPT, PhD | Ohio University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio University | Athens | Ohio | 45701 | United States |
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A 2 armed sequential, multiple-assignment randomized trial design
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The investigator was masked to the initial treatment assignment. The outcome assessor was not masked to treatment assignment and monitored treatment response at the mid-intervention in order to recommend continuation of current treatment or to augment treatment with the Healthy Mind Innovations training program for individuals who did not favorably respond to standalone PT.
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| Baseline (T0) and post-treatment/week 26 (T2) |
| Pain acceptance | Chronic Pain Acceptance Questionnaire (CPAQ-20) | Baseline (T0) and post-treatment/week 26 (T2) |
| Committed action | Committed Action Questionnaire (CAQ-8) | Baseline (T0) and post-treatment/week 26 (T2) |
| Healthy emotionality | Emotional Styles Questionnaire (ESQ) | Baseline (T0) and post-treatment/week 26 (T2) |
| Exercise behavior | Stanford Exercise Behavior Scale (SEBS) | Baseline (T0), mid-treatment/week 10 (T1), post-treatment/week 26 (T2), and post-treatment/week 52 (T3) |
| Back pain screening tool 1 | Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-10) | Baseline (T0) |
| Back pain screening tool 1 | Start Back Screening Tool (SBST-9) | Baseline (T0) |
| Kinesiophobia | Tampa Scale of Kinesiophobia (TSK-11) | Baseline (T0) |
| Attitudes towards complementary and alternative medicine | Healthcare Experiences and Attitudes List - Attitudes Towards Complementary and Alternative Medicine (HEAL-CAM) | Baseline (T0) |
| Treatment expectancy | HEAL Treatment Expectancy (HEAL-TEX) | Baseline (T0) |
| Lumbar pressure pain threshold | Quantitative Sensory Testing | Baseline (T0) and week 26 (T2) |
| Thermal method of limits | Quantitative Sensory Testing | Baseline (T0) and week 26 (T2) |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D019122 | Meditation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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