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Completed

NCT Number: NCT06351774

Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University

Athens, Ohio, 45701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Meditation

Primary outcomes

  1. Oswestry Disability Index

    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

  2. PROMIS Pain Interference

    Time frame: Baseline (T0), post-treatment/week 26 (T2), and post-treatment/week 52 (T3)

    A self-reported outcome measure of pain interference

Secondary outcomes

  1. Actigraphy

    Time frame: Baseline (T0) and post-treatment/week 26 (T2)

    Measure of physical activity levels for 10 days of home use

  2. 3D Motion Capture

    Time frame: Baseline (T0) and post-treatment/week 26 (T2)

    Trunk motion capture during walking and lifting tasks

  3. Pain acceptance

    Time frame: Baseline (T0) and post-treatment/week 26 (T2)

    Chronic Pain Acceptance Questionnaire (CPAQ-20)

  4. Committed action

    Time frame: Baseline (T0) and post-treatment/week 26 (T2)

    Committed Action Questionnaire (CAQ-8)

  5. Healthy emotionality

    Time frame: Baseline (T0) and post-treatment/week 26 (T2)

    Emotional Styles Questionnaire (ESQ)

  6. Exercise behavior

    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)

  7. Back pain screening tool 1

    Time frame: Baseline (T0)

    Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-10)

  8. Back pain screening tool 1

    Time frame: Baseline (T0)

    Start Back Screening Tool (SBST-9)

  9. Kinesiophobia

    Time frame: Baseline (T0)

    Tampa Scale of Kinesiophobia (TSK-11)

  10. Attitudes towards complementary and alternative medicine

    Time frame: Baseline (T0)

    Healthcare Experiences and Attitudes List - Attitudes Towards Complementary and Alternative Medicine (HEAL-CAM)

  11. Treatment expectancy

    Time frame: Baseline (T0)

    HEAL Treatment Expectancy (HEAL-TEX)

  12. Lumbar pressure pain threshold

    Time frame: Baseline (T0) and week 26 (T2)

    Quantitative Sensory Testing

  13. Thermal method of limits

    Time frame: Baseline (T0) and week 26 (T2)

    Quantitative Sensory Testing

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Collaborators

  • University of Wisconsin, Madison

Registry information

Official study title

An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain

Acronym: AdaPT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2024
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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