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

NCT06351774 | Completed

• 1 other identifier: 21-F-45
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Back Pain Lower Back Chronic; Disability Physical

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Actigraphy

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

• 3D Motion Capture

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

• Pain acceptance

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

• Committed action

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

• Healthy emotionality

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

Study Arms (2)

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).

Behavioral: Physical therapy

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).

Behavioral: Physical therapy

Interventions

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.

Also known as: Meditation

PT; PT+HMI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio University: lead
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Interventions

Physical Therapy Modalities; Meditation

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nicholas V Karayannis, MPT, PhD

  Ohio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 2 armed sequential, multiple-assignment randomized trial design

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: May 24, 2022
• Primary Completion: February 8, 2024
• Study Completion: March 25, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

US (1)