Chronic Low-back PainIMPACTNCT06106191
Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment
A study testing Mindfulness meditation, Perspectives on pain and Discussion in people with Chronic Low-back Pain, run by Boston Medical Center at 1 site in United States.
Trial summary
This study will identify unique signatures that people have which can cause pain by evaluating biological, psychological, and social markers using artificial intelligence. These markers can be used to accurately predict the response of diverse individuals with chronic low back pain (cLBP) to Mindfulness-Based Stress… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Mindfulness meditation, Perspectives on pain and Discussion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2024to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Chronic low back pain, which is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months
- Willing and able to provide online or telephone informed consent
- Speak English as the intervention manual is currently written in English
Who cannot join
- Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss
- Pregnancy
- Metastatic cancer
- Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 6 or more months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02116
Natalia Morone, MD MS, 617-414-6652, Natalia.Morone@bmc.org
Jose Baez, MD, 617-272-6848, Jose.Baez@bmc.org
About this study
This study will identify unique signatures that people have which can cause pain by evaluating biological, psychological, and social markers using artificial intelligence. These markers can be used to accurately predict the response of diverse individuals with chronic low back pain (cLBP) to Mindfulness-Based Stress Reduction. This will help enhance clinician decision-making and the targeted treatment of chronic pain.
The overall objective is to use a unique machine learning (ML) approach to determine the biomarker signature of persons undergoing mindfulness based stress reduction (MBSR) treatment for their chronic low back pain (cLBP). This signature will facilitate clinical prediction and monitoring of patient response to MBSR treatment.
The design of the study is a single-arm clinical trial of the evidence-based MBSR program for patients with cLBP.
Read the detailed description
UG3 Phase Overview. The first 24-months of the project will be dedicated to performing machine learning modeling to identify candidate predictive and monitoring markers of cLBP response to MBSR, prior to the full clinical trial in the UH3 phase. We will also refine our procedures such as recruitment and outcomes assessment with 50 persons during the UG3 phase.
UH3 Phase Overview. Biopsychosocial markers will be identified of the response of diverse cLBP patients to MBSR (N=300) from comprehensive pain assessment and biopsychosocial data, including pain intensity and pain interference, physical activity, sleep, and heart rate for a 6-month period. Data will be collected and used for training and testing ML models. The MBSR program is evidence-based and meets weekly in a group via Zoom for 8-weeks for 90 minutes per week. Measures to determine biomarkers will be obtained at baseline (T1), four-weeks (T2), program completion (T3), four months (T4), and six months (T5). The main outcome timepoint with be at six months (T5), which allows time for durability of effects to be determined. The PEG (Pain, Enjoyment, General activity), obtained through online self-report surveys is the main outcome measure. Secondary outcomes of physical and psychological function will be self-report and obtained online, or if the patient prefers, by telephone, and physical activity, sleep, and heart rate variability will be collected by Fitbit.
- Conditions
- Chronic Low-back Pain
- Being tested
- Mindfulness meditation, Perspectives on pain, Discussion
- Keywords
- Mindfulness based stress reduction (MBSR), Machine learning (ML), Biopsychosocial data, PEG (Pain, Enjoyment, General activity), Pain interference, Pain intensity, Depression
- Medical subject headings
- Pain, Motor Activity, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationBehavioural
Ordinary activities like breathing, eating, and walking are turned into a meditation by creating greater awareness of the moment-to-moment sensations, emotions, thoughts and behaviors that arise during these activities.
Perspectives on painOther
Understanding pain from a mind-body perspective and viewing pain as a stressor on physical sensations, thoughts, emotions, and behavior.
DiscussionOther
Discussion on patients' use of mindfulness to work with pain and pain-themed meditations.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness based stress reduction (MBSR) program | Experimental | Participants will be enrolled in a 8-week mindfulness clinical pain program + Primary Care Provider (PCP) Usual Care. Receives: Behavioral: Mindfulness meditation; Other: Perspectives on pain; Other: Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, Enjoyment, General activity (PEG) composite score
The PEG is a 3-question scale: "pain average", "interference with general activity" and "interference with enjoyment of life". Each question is on a 0-10 scale, and total PEG is the average. Scores can range from 0-30 and <12=Mild,12 to <21 = Moderate, 21 to 30 = Severe chronic pain.
Measured: 6 months
Secondary outcomes (11)
Depression assessed by the eight-item Patient Health Questionnaire for Depression (PHQ-8)
The total score is determined by adding together the scores of each of the four items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Anxiety assessed by the Generalized Anxiety Disorder-7 (GAD-7)
This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Pain Self-Efficacy assessed by the Pain Self-Efficacy Questionnaire
The PSEQ is a 10-question survey that measures the confidence of a person with persistent pain to do a range of activities while in pain. The total score ranges from 0 to 60. High PSEQ scores are strongly associated with clinically- significant functional levels and provide a useful gauge for evaluating outcomes in chronic pain patients. Higher scores (and a higher percentile) represent higher confidence to function with pain.
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Catastrophizing assessed by the Pain Catastrophizing Scale Short Form
The Pain Catastrophizing Scale (PCS) measures three aspects of catastrophic cognitions about pain-rumination, magnification, and helplessness. It consists of 13 items scored from 0 to 4, with a total range of 0 to 52. Higher scores are less favorable and a score of more than 30 points may indicate clinical relevance.
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Quality of Life assessed by the Patient Reported Outcomes Measurement Information System (PROMIS 29)
The PROMIS-29 v2. 0 profile measure assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items for each domain. HIgher scores indicate greater pain intensity.
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Participants' Impression of change
Patient Global Impression of Change (PGIC) will be used to assess this outcome. A score of 1=No change (or condition has got worse), 2 = Almost the same, hardly any change at all, 3 = A little better, but no noticeable change, 4 = Somewhat better, but the change has not made any real difference, 5 = Moderately better, and a slight but noticeable change, 6 = Better, and a definite improvement that has made a real and worthwhile difference 7 = A great deal better, and a considerable improvement that has made all the difference. A 2-point change is significant from the last reported score
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Mindfulness assessed by the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
The CAMS-R is a 12-item measure designed to capture a broad conceptualization of mindfulness with language that is not specific to any particular type of meditation training. Items 2, 6, and 7 are reverse-scored. After appropriate reversals, values for items 1 - 12 are summed. Higher values reflect greater mindful qualities.
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Sleep disturbance assessed by the PROMIS Sleep Disturbance-Short Form 6a
The PROMIS 6a scale is composed of 6 items developed to assess the domain of sleep disturbances in the past 7 days. The first two scale items assess sleep quality and the following 4 items assess domains of restfulness, sleep problems, and difficulty falling asleep. Each question has five response options ranging in value from one to five. To find the total raw score for a short so the range of scores is 6 to 30.
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Pain-Sleep Duration
One question assesses sleep duration. This survey measures the impact of pain on the quality of sleep
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Treatment components and effects assessed by the Healing Encounters and Attitudes List-Expectation
Six questions ask about treatment expectancy. It assesses participants' attitudes towards and perceptions of treatment components that associated with nont specific treatment effects
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Social support assessed by the Social Network Index
12 questions that ask about social support in regards to how many people a person sees and talk to regularly. The total score is calculated by finding the sum of the all items with a higher score indicating more social engagement.
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start25 Jul 2024
- Primary completionSep 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Worcester Polytechnic Institute
- Responsible party
- Sponsor
- Investigators
- Natalia Morone, MD MS, Principal investigator, Boston Medical CenterJean King, PhD, Principal investigator, Worcester Polytechnic InstituteEmmanuel Agu, PhD, Principal investigator, Worcester Polytechnic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106191
- Sponsor's protocol ID
- H-44407
- Other IDs
- UG3NS135168
- Acronym
- IMPACT
- Status last verified
- Jun 2026
- First submitted
- 24 Oct 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment
- ClinicalTrials.gov ID
- NCT06106191
- Acronym / sponsor ID
- IMPACT / H-44407
- Conditions
- Chronic Low-back Pain
- Keywords
- Mindfulness based stress reduction (MBSR), Machine learning (ML), Biopsychosocial data, PEG (Pain, Enjoyment, General activity), Pain interference, Pain intensity, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Worcester Polytechnic Institute
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 30 Oct 2023 (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.
This study will identify unique signatures that people have which can cause pain by evaluating biological, psychological, and social markers using artificial intelligence. These markers can be used to accurately predict the response of diverse individuals with chronic low back pain (cLBP) to Mindfulness-Based Stress Reduction. This will help enhance clinician decision-making and the targeted treatment of chronic pain.
The overall objective is to use a unique machine learning (ML) approach to determine the biomarker signature of persons undergoing mindfulness based stress reduction (MBSR) treatment for their chronic low back pain (cLBP). This signature will facilitate clinical prediction and monitoring of patient response to MBSR treatment.
The design of the study is a single-arm clinical trial of the evidence-based MBSR program for patients with cLBP.
Detailed description
UG3 Phase Overview. The first 24-months of the project will be dedicated to performing machine learning modeling to identify candidate predictive and monitoring markers of cLBP response to MBSR, prior to the full clinical trial in the UH3 phase. We will also refine our procedures such as recruitment and outcomes assessment with 50 persons during the UG3 phase.
UH3 Phase Overview. Biopsychosocial markers will be identified of the response of diverse cLBP patients to MBSR (N=300) from comprehensive pain assessment and biopsychosocial data, including pain intensity and pain interference, physical activity, sleep, and heart rate for a 6-month period. Data will be collected and used for training and testing ML models. The MBSR program is evidence-based and meets weekly in a group via Zoom for 8-weeks for 90 minutes per week. Measures to determine biomarkers will be obtained at baseline (T1), four-weeks (T2), program completion (T3), four months (T4), and six months (T5). The main outcome timepoint with be at six months (T5), which allows time for durability of effects to be determined. The PEG (Pain, Enjoyment, General activity), obtained through online self-report surveys is the main outcome measure. Secondary outcomes of physical and psychological function will be self-report and obtained online, or if the patient prefers, by telephone, and physical activity, sleep, and heart rate variability will be collected by Fitbit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness based stress reduction (MBSR) program | Experimental | Behavioral: Mindfulness meditation, Other: Perspectives on pain, Other: DiscussionParticipants will be enrolled in a 8-week mindfulness clinical pain program + Primary Care Provider (PCP) Usual Care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic low back pain, which is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months
- Willing and able to provide online or telephone informed consent
- Speak English as the intervention manual is currently written in English
Key exclusion criteria (4 listed)
- Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss
- Pregnancy
- Metastatic cancer
- Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 6 or more 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 |
|---|---|---|
| Mindfulness meditationOrdinary activities like breathing, eating, and walking are turned into a meditation by creating greater awareness of the moment-to-moment sensations, emotions, thoughts and behaviors that arise during these activities. | Behavioural | Mindfulness based stress reduction (MBSR) program |
| Perspectives on painUnderstanding pain from a mind-body perspective and viewing pain as a stressor on physical sensations, thoughts, emotions, and behavior. | Other | Mindfulness based stress reduction (MBSR) program |
| DiscussionDiscussion on patients' use of mindfulness to work with pain and pain-themed meditations. | Other | Mindfulness based stress reduction (MBSR) program |
Primary outcome
Pain, Enjoyment, General activity (PEG) composite score
Time frame: 6 months
The PEG is a 3-question scale: "pain average", "interference with general activity" and "interference with enjoyment of life". Each question is on a 0-10 scale, and total PEG is the average. Scores can range from 0-30 and <12=Mild,12 to <21 = Moderate, 21 to 30 = Severe chronic pain.
11 secondary outcomes
Depression assessed by the eight-item Patient Health Questionnaire for Depression (PHQ-8)
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Anxiety assessed by the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Pain Self-Efficacy assessed by the Pain Self-Efficacy Questionnaire
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Catastrophizing assessed by the Pain Catastrophizing Scale Short Form
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Quality of Life assessed by the Patient Reported Outcomes Measurement Information System (PROMIS 29)
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Participants' Impression of change
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Mindfulness assessed by the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Sleep disturbance assessed by the PROMIS Sleep Disturbance-Short Form 6a
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Pain-Sleep Duration
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Treatment components and effects assessed by the Healing Encounters and Attitudes List-Expectation
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Social support assessed by the Social Network Index
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Natalia Morone, MD MS principal investigator
Boston Medical Center
Jean King, PhD principal investigator
Worcester Polytechnic Institute
Emmanuel Agu, PhD principal investigator
Worcester Polytechnic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation, Perspectives on pain and Discussion in people with Chronic Low-back Pain, run by Boston Medical Center 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Morone, MD MS (617-414-6652, Natalia.Morone@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain, Enjoyment, General activity (PEG) composite score (time frame: 6 months). 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 30 Jun 2026.