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

Disability Physical Clinical Trial

— AdaPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06351774
• Other study ID #: 21-F-45
• Status: Completed
• Phase: N/A
• Start date: May 24, 2022
• Est. completion date: March 25, 2024

Study information

• Verified date: April 2024
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 25, 2024
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic
• Disability Physical
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio University	University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Actigraphy	Measure of physical activity levels for 10 days of home use	Baseline (T0) and post-treatment/week 26 (T2)
Secondary	3D Motion Capture	Trunk motion capture during walking and lifting tasks	Baseline (T0) and post-treatment/week 26 (T2)
Secondary	Pain acceptance	Chronic Pain Acceptance Questionnaire (CPAQ-20)	Baseline (T0) and post-treatment/week 26 (T2)
Secondary	Committed action	Committed Action Questionnaire (CAQ-8)	Baseline (T0) and post-treatment/week 26 (T2)
Secondary	Healthy emotionality	Emotional Styles Questionnaire (ESQ)	Baseline (T0) and post-treatment/week 26 (T2)
Secondary	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)
Secondary	Back pain screening tool 1	Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-10)	Baseline (T0)
Secondary	Back pain screening tool 1	Start Back Screening Tool (SBST-9)	Baseline (T0)
Secondary	Kinesiophobia	Tampa Scale of Kinesiophobia (TSK-11)	Baseline (T0)
Secondary	Attitudes towards complementary and alternative medicine	Healthcare Experiences and Attitudes List - Attitudes Towards Complementary and Alternative Medicine (HEAL-CAM)	Baseline (T0)
Secondary	Treatment expectancy	HEAL Treatment Expectancy (HEAL-TEX)	Baseline (T0)
Secondary	Lumbar pressure pain threshold	Quantitative Sensory Testing	Baseline (T0) and week 26 (T2)
Secondary	Thermal method of limits	Quantitative Sensory Testing	Baseline (T0) and week 26 (T2)