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

Study Overview

• Status: Completed
• Conditions: Disability Physical; Back Pain Lower Back Chronic
• Intervention / Treatment: Behavioral: Physical therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Athens, Ohio, United States, 45701
      • Ohio University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PT; 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).	Behavioral: Physical therapy; 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
Experimental: PT+HMI; 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).	Behavioral: Physical therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Ohio University
• Collaborators: University of Wisconsin, Madison
• Investigators: Principal Investigator: Nicholas V Karayannis, MPT, PhD, Ohio University

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2022
• Primary Completion (Actual): February 8, 2024
• Study Completion (Actual): March 25, 2024

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 21-F-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No