Back Pain Lower Back ChronicAdaPTNCT06351774
Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain
A study testing Physical therapy in people with Back Pain Lower Back Chronic and Disability Physical, run by Ohio University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain Lower Back Chronic, Disability Physical
- What is being tested?
- Physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2022to 25 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Back Pain Lower Back Chronic, Disability Physical
- Being tested
- Physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapyBehavioural
Also called Meditation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
A self-reported outcome measure of back disability
Measured: 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
Measured: Baseline (T0), post-treatment/week 26 (T2), and post-treatment/week 52 (T3)
Secondary outcomes (13)
Actigraphy
Measure of physical activity levels for 10 days of home use
Measured: Baseline (T0) and post-treatment/week 26 (T2)
3D Motion Capture
Trunk motion capture during walking and lifting tasks
Measured: Baseline (T0) and post-treatment/week 26 (T2)
Pain acceptance
Chronic Pain Acceptance Questionnaire (CPAQ-20)
Measured: Baseline (T0) and post-treatment/week 26 (T2)
Committed action
Committed Action Questionnaire (CAQ-8)
Measured: Baseline (T0) and post-treatment/week 26 (T2)
Healthy emotionality
Emotional Styles Questionnaire (ESQ)
Measured: Baseline (T0) and post-treatment/week 26 (T2)
Exercise behavior
Stanford Exercise Behavior Scale (SEBS)
Measured: 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)
Measured: Baseline (T0)
Back pain screening tool 1
Start Back Screening Tool (SBST-9)
Measured: Baseline (T0)
Kinesiophobia
Tampa Scale of Kinesiophobia (TSK-11)
Measured: Baseline (T0)
Attitudes towards complementary and alternative medicine
Healthcare Experiences and Attitudes List - Attitudes Towards Complementary and Alternative Medicine (HEAL-CAM)
Measured: Baseline (T0)
Treatment expectancy
HEAL Treatment Expectancy (HEAL-TEX)
Measured: Baseline (T0)
Lumbar pressure pain threshold
Quantitative Sensory Testing
Measured: Baseline (T0) and week 26 (T2)
Thermal method of limits
Quantitative Sensory Testing
Measured: Baseline (T0) and week 26 (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start24 May 2022
- Primary completion8 Feb 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A 2 armed sequential, multiple-assignment randomized trial design
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Nicholas V Karayannis, MPT, PhD, Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351774
- Sponsor's protocol ID
- 21-F-45
- Acronym
- AdaPT
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06351774
- Acronym / sponsor ID
- AdaPT / 21-F-45
- Conditions
- Back Pain Lower Back Chronic, Disability Physical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Study start
- 24 May 2022 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A 2 armed sequential, multiple-assignment randomized trial design
| Arm | Type | Receives |
|---|---|---|
| PT | Experimental | Behavioral: Physical therapyParticipants 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). |
| PT+HMI | Experimental | Behavioral: Physical therapyParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapyAlso: MeditationPhysical 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. | Behavioural | PT, PT+HMI |
Primary outcome
Oswestry Disability Index
Time frame: 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
Time frame: Baseline (T0), post-treatment/week 26 (T2), and post-treatment/week 52 (T3)
A self-reported outcome measure of pain interference
13 secondary outcomes
Actigraphy
Time frame: Baseline (T0) and post-treatment/week 26 (T2)
3D Motion Capture
Time frame: Baseline (T0) and post-treatment/week 26 (T2)
Pain acceptance
Time frame: Baseline (T0) and post-treatment/week 26 (T2)
Committed action
Time frame: Baseline (T0) and post-treatment/week 26 (T2)
Healthy emotionality
Time frame: Baseline (T0) and post-treatment/week 26 (T2)
Exercise behavior
Time frame: Baseline (T0), mid-treatment/week 10 (T1), post-treatment/week 26 (T2), and post-treatment/week 52 (T3)
Back pain screening tool 1
Time frame: Baseline (T0)
Back pain screening tool 1
Time frame: Baseline (T0)
Kinesiophobia
Time frame: Baseline (T0)
Attitudes towards complementary and alternative medicine
Time frame: Baseline (T0)
Treatment expectancy
Time frame: Baseline (T0)
Lumbar pressure pain threshold
Time frame: Baseline (T0) and week 26 (T2)
Thermal method of limits
Time frame: Baseline (T0) and week 26 (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas V Karayannis, MPT, PhD principal investigator
Ohio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy in people with Back Pain Lower Back Chronic and Disability Physical, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: Baseline (T0), mid-treatment/week 10 (T1), post-treatment/week 26 (T2), and post-treatment/week 52 (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.