Back Pain Lower Back Chronic, Disability Physical
Conditions
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.
Interventions
BEHAVIORALPhysical 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.
Sponsors
University of Wisconsin, Madison
Ohio University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
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.
Intervention model description
A 2 armed sequential, multiple-assignment randomized trial design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index | 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 |
| PROMIS Pain Interference | Baseline (T0), post-treatment/week 26 (T2), and post-treatment/week 52 (T3) | A self-reported outcome measure of pain interference |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain acceptance | Baseline (T0) and post-treatment/week 26 (T2) | Chronic Pain Acceptance Questionnaire (CPAQ-20) |
| Committed action | Baseline (T0) and post-treatment/week 26 (T2) | Committed Action Questionnaire (CAQ-8) |
| Healthy emotionality | Baseline (T0) and post-treatment/week 26 (T2) | Emotional Styles Questionnaire (ESQ) |
| Exercise behavior | Baseline (T0), mid-treatment/week 10 (T1), post-treatment/week 26 (T2), and post-treatment/week 52 (T3) | Stanford Exercise Behavior Scale (SEBS) |
| Back pain screening tool 1 | Baseline (T0) | Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ-10) |
| Actigraphy | Baseline (T0) and post-treatment/week 26 (T2) | Measure of physical activity levels for 10 days of home use |
| Attitudes towards complementary and alternative medicine | Baseline (T0) | Healthcare Experiences and Attitudes List - Attitudes Towards Complementary and Alternative Medicine (HEAL-CAM) |
| Treatment expectancy | Baseline (T0) | HEAL Treatment Expectancy (HEAL-TEX) |
| Lumbar pressure pain threshold | Baseline (T0) and week 26 (T2) | Quantitative Sensory Testing |
| Thermal method of limits | Baseline (T0) and week 26 (T2) | Quantitative Sensory Testing |
| Kinesiophobia | Baseline (T0) | Tampa Scale of Kinesiophobia (TSK-11) |
| 3D Motion Capture | Baseline (T0) and post-treatment/week 26 (T2) | Trunk motion capture during walking and lifting tasks |
Countries
United States
Outcome results
None listed