Clinical trial NCT06351774: Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain
Official title: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain Lower Back Chronic
Disability Physical
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Madison
First posted: 2024-04-08
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A 2 armed sequential, multiple-assignment randomized trial design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: Baseline (T0), mid-treatment/week 10 (T1), post-treatment/week 26 (T2), and post-treatment/week 52 (T3)
measure: PROMIS Pain Interference
timeFrame: Baseline (T0), post-treatment/week 26 (T2), and post-treatment/week 52 (T3)
Secondary outcomes:
measure: Actigraphy
timeFrame: Baseline (T0) and post-treatment/week 26 (T2)
measure: 3D Motion Capture
timeFrame: Baseline (T0) and post-treatment/week 26 (T2)
measure: Pain acceptance
timeFrame: Baseline (T0) and post-treatment/week 26 (T2)
measure: Committed action
timeFrame: Baseline (T0) and post-treatment/week 26 (T2)
measure: Healthy emotionality
timeFrame: Baseline (T0) and post-treatment/week 26 (T2)
measure: Exercise behavior
timeFrame: Baseline (T0), mid-treatment/week 10 (T1), post-treatment/week 26 (T2), and post-treatment/week 52 (T3)
measure: Back pain screening tool 1
timeFrame: Baseline (T0)
measure: Back pain screening tool 1
timeFrame: Baseline (T0)
measure: Kinesiophobia
timeFrame: Baseline (T0)
measure: Attitudes towards complementary and alternative medicine
timeFrame: Baseline (T0)
measure: Treatment expectancy
timeFrame: Baseline (T0)
measure: Lumbar pressure pain threshold
timeFrame: Baseline (T0) and week 26 (T2)
measure: Thermal method of limits
timeFrame: Baseline (T0) and week 26 (T2)
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
affiliation: Ohio University
name: Nicholas V Karayannis, MPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: