Chronic PainNCT05812703
Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain
An observational study of Chronic Pain and Sedentary Time, run by Stanford University at 1 site in United States.
Trial summary
The study will provide important information regarding the biometric changes that occur in behavioral treatments for chronic pain and explore the additional impact of integrated movement and supervised exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Sedentary Time
- What is being tested?
- Cognitive Behavioral Therapy, Acceptance and Commitment Therapy (ACT) and Moderate to high Intensity Group Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2024to 25 Apr 2026
- How long will I take part?
- 8 Months
- Phase
- Observational
- 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
Study population: Participants with chronic pain
Who may be able to join
- Age 18+
- Non-cancer chronic pain (pain that occurs on at least half of the days of 6 months or more)
- English fluency
- Ability to attend >70% treatment sessions to ensure active treatment is delivered
Who cannot join
- Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
- Participants with acute cauda equina syndrome
- Inability to complete a 6 minute walk test without LOB
- 3) Chronic pain as explained by inflammatory disease
- For the movement-based portions of group:
- Exclusion: For our CBT + Movement (low intensity/ restorative) movement group: Patient must be able to sit upright for 20 minutes without loss of balance or upper extremity (UE) assistance. Inability to sit without use of UE support would be excluded. This ensures safety that the participant can completed the adapted movement program without risk of falls. HR will not be elevated > 50% HRmax in these restorative movement classes.
- Exclusion criteria for the Back in ACTion (higher intensity) movement group is inability to complete a 6-minute walk test safely or without loss of balance, as this poses a fall risk that requires individual assistance throughout the class, or medical exclusion from cardiovascular exercise over 50% HRmax, as HR will be elevated to 50-70% HR max in these classes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Pain Management Clinic
Redwood City, California, 94061
About this study
Official title: What Objective Changes Occur With Behavioral Treatment: Evaluating Biometrics and Self -Reported Health Measures of Adult Patients Receiving Behavioral Treatments With Chronic Pain
The study will provide important information regarding the biometric changes that occur in behavioral treatments for chronic pain and explore the additional impact of integrated movement and supervised exercise. The goal of this clinical trial is to determine if pain rehabilitation programs have impacts on physical function in patient reported outcomes and objective measures of physical activity or sedentary time with a wearable Fitbit. Additionally, we will examine the associations between movement, pain acceptance, and related health factors, such as pain severity, sleep, functional status, depression, and anxiety. The addition of biometric data will allow for further investigation of the association between objective measures and patient self-report measures.
Read the detailed description
Chronic pain has high impact on societal function as well as an individual person's mood, physical function, disability, and quality of life and their health. The purpose of the study is to collect objective outcome measures on movement, activity, biometrics and patient reported outcome measures for participants of behavioral treatment groups of 6-8 weeks duration at Stanford Pain Management Center. Group participants learn skills and develop a personalized plan to use the skills throughout the program. The study will follow participants with a removable wearable device on the wrist for 2 weeks pre group to establish movement activity baselines, during the group intervention (6-8 weeks) and 2 weeks post group to determine which groups have benefits across various aspects of health including: sleep, psychological processes of pain acceptance, physical mobility, quality of life and the impact of supervised movement and physical activity in the treatment groups.
- Conditions
- Chronic Pain, Sedentary Time
- Being tested
- Cognitive Behavioral Therapy, Acceptance and Commitment Therapy (ACT), Moderate to high Intensity Group Exercise
- Keywords
- movement, behavioral treatments, biometrics, chronic pain
- Medical subject headings
- Chronic Pain, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called Pain Coping Skills, Group Movement
The participants will attend one of the behavioral group treatments programs offered by the Stanford Pain Management Center. This class may be held online via Zoom, or in person based at the Stanford Pain Management Center. The class may be recorded for training purposes. No names or images/faces will be recorded for privacy reasons. The behavioral groups are 3 types, with or without exercise/movement. Current Evidence Based treatments that are provided as standard practice include: Cognitive Behavioral Therapy Group, with movement, Acceptance and Commitment Therapy Group, with or without movement. Group participants will learn different skills in each group and develop a personalized plan to use the skills after group ends. At the end of group participants will be given an anonymous survey about the class to evaluate satisfaction of the treatment. Movement in this portion of class is designed to low impact and restorative/gentle, with no significant increases in HR > 50% HRmax.
Acceptance and Commitment Therapy (ACT)Behavioural
ACT is a 6 week behavioral group program led by a psychologist to improve psychological flexibility and reduce pain interference in patients with chronic pain.
Moderate to high Intensity Group ExerciseBehavioural
Group exercise led by supervised clinician with Cardiovascular focus to increase HR into zones to see adaptations to improve cardiovascular fitness.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Group Treatment (Cognitive Behavioral Therapy CBT + Movement) | Cognitive Behavioral Therapy Group led by a psychologist to learn pain coping skills, with gentle movement component of duration from 45 minutes to 60 minutes under a licensed Healthcare provider (PT or OT). Receives: Behavioral: Cognitive Behavioral Therapy | |
| Behavioral Group Treatment (ACT) only | Acceptance and Commitment Therapy Group led by a psychologist to learn skills to change their relationship with pain to decrease pain's impact on their life. Receives: Behavioral: Acceptance and Commitment Therapy (ACT) | |
| Behavioral Group Treatment (ACT + Movement)- Back in ACTion | Acceptance and Commitment Therapy Group led by a psychologist to learn skills to change their relationship with pain to decrease pain's impact on their life and improve willingness to engage in valued activities. Movement component to last from with intense and gentle movement sessions with a total movement time of 90 minutes - 2 hours led by licensed health care provider a PT or OT. Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Moderate to high Intensity Group Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sedentary behavior time
Sedentary behavior is defined as any waking behavior such as sitting or leaning with an energy expenditure of 1.5 metabolic equivalent task (MET) or less
Measured: Pre intervention (baseline), and post intervention (at 10 weeks)
Secondary outcomes (12)
HF-Heart rate variability
Heart rate variability (per participant) is where the amount of time between your heartbeats fluctuates slightly. Even though these fluctuations are undetectable except with specialized devices, they can still indicate current or future health problems, including heart conditions and mental health issues like anxiety and depression. Heart rate variability (in milliseconds) has no standard reference range. HF is the high frequency band of HRV.
Measured: Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
Sleep Duration
Amount of time asleep per "night cycle"
Measured: Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
Daily Step Count
Amount of steps occurring in a 24 hour day
Measured: Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
Pain Catastrophizing
13-item self-report measure designed to assess catastrophic thinking related to pain among adults. The score ranges from 0-52, where higher scores indicate greater pain catastrophizing.
Measured: Pre intervention (baseline), and post intervention (at 10 weeks) and 6 months follow up (post group)
PROMIS Depression Score
Self reported Questionnaires to assess depression. Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression use a T-score metric, and the scores range from 10T to 85T, with the population mean score of 50T (SD of 10). Higher T scores would indicate worse symptom in each domain.
Measured: Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
PROMIS Anxiety Score
Self reported Questionnaires to assess anxiety. Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety measures use a T-score metric, and the scores range from 10T to 85T, with the population mean score of 50T (SD of 10). Higher T scores would indicate worse symptom in each domain.
Measured: Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
PROMIS Sleep Disturbance Score
Self reported Questionnaires to assess sleep quality. Patient-Reported Outcomes Measurement Information System (PROMIS) , Sleep Disturbance use a T-score metric, and the scores range from 10T to 85T, with the population mean score of 50T (SD of 10). Higher T scores would indicate worse symptom in each domain.
Measured: Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
PROMIS Physical Function Score
Self reported Questionnaires to assess physical function/mobility. Patient-Reported Outcomes Measurement Information System (PROMIS) physical function measures use a T-score metric, and the scores range from 10T to 85T, with the population mean score of 50T (SD of 10). Higher T scores would indicate worse symptom in each domain.
Measured: Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
PROMIS Pain Interference Score
Self-reported Questionnaires to assess pain interference. Patient-Reported Outcomes Measurement Information System (PROMIS), pain interference, and physical function measures use a T-score metric, and the scores range from 10T to 85T, with the population mean score of 50T (SD of 10). Higher T scores would indicate worse symptom in each domain.
Measured: Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
Duration of Heart Rate in Exercise Zones (50-70% HRMax) (during exercise)
The time in a 24 hour period that the participant has an elevated heartrate for sustained duration indicating exercise.
We would want to increase our amount of time (minutes) in HRzones to indicate more time spend in active exercise during the movement portions of the interventions.
Measured: Pre intervention (baseline), and post intervention (at 10 weeks)
Average Resting Heartrate
A 2013 study in the journal Heart tracked the cardiovascular health of about 3,000 men for 16 years and found that a high resting heart rate was linked with lower physical fitness and higher blood pressure, body weight, and levels of circulating blood fats. The researchers also discovered that the higher a person's resting heart rate, the greater the risk of premature death. Specifically, an RHR between 81 and 90 doubled the chance of death, while an RHR higher than 90 tripled it.
A low resting heart rate often suggests greater physical fitness. A reduction in average resting heart rate would indicate improvement in CV fitness for our treatment interventions.
Measured: Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
Physical Activity Vital Sign
the subjective measure of minutes a person is physically active in a week (in minutes)
Measured: Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start27 Sep 2024 (estimated)
- Primary completion25 Oct 2025 (estimated)
- Study completion25 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Poupore-King, Stanford University
- Investigators
- Heather King, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812703
- Sponsor's protocol ID
- 66952
- Status last verified
- May 2024
- First submitted
- 31 Mar 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
You DS, Ziadni MS, Cooley CE, Talavera DC, Mackey SC, Poupore-King H. Effectiveness of a multidisciplinary rehabilitation program in real-world patients with chronic back pain: A pilot cohort data analysis. J Back Musculoskelet Rehabil. 2021;34(6):965-973. doi: 10.3233/BMR-200305.
PubMed 34151829Neumann A, Hampel P. Long-term effects of rehabilitation and prevention of further chronification of pain among patients with non-specific low back pain. J Back Musculoskelet Rehabil. 2022;35(6):1257-1268. doi: 10.3233/BMR-210221.
PubMed 35754259Pears S, Sutton S. Effectiveness of Acceptance and Commitment Therapy (ACT) interventions for promoting physical activity: a systematic review and meta-analysis. Health Psychol Rev. 2021 Mar;15(1):159-184. doi: 10.1080/17437199.2020.1727759. Epub 2020 Feb 17.
PubMed 32036768Mercer K, Li M, Giangregorio L, Burns C, Grindrod K. Behavior Change Techniques Present in Wearable Activity Trackers: A Critical Analysis. JMIR Mhealth Uhealth. 2016 Apr 27;4(2):e40. doi: 10.2196/mhealth.4461.
PubMed 27122452Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.
PubMed 29034226Karayannis NV, Sturgeon JA, Kemani MK, Mackey SC, Greco CM, Wicksell RK, McCracken LM. Pain acceptance and psychological inflexibility predict pain interference outcomes for persons with chronic pain receiving pain psychology. Scand J Pain. 2023 Feb 7;23(3):464-475. doi: 10.1515/sjpain-2022-0107. Print 2023 Jul 26.
PubMed 36745187
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Objective Changes Occur With Behavioral Treatment: Evaluating Biometrics and Self -Reported Health Measures of Adult Patients Receiving Behavioral Treatments With Chronic Pain
- ClinicalTrials.gov ID
- NCT05812703
- Acronym / sponsor ID
- 66952
- Conditions
- Chronic Pain, Sedentary Time
- Keywords
- movement, behavioral treatments, biometrics, chronic pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 27 Sep 2024 (estimated)
- Primary completion
- 25 Oct 2025 (estimated)
- Study completion
- 25 Apr 2026 (estimated)
- First posted
- 14 Apr 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.
The study will provide important information regarding the biometric changes that occur in behavioral treatments for chronic pain and explore the additional impact of integrated movement and supervised exercise. The goal of this clinical trial is to determine if pain rehabilitation programs have impacts on physical function in patient reported outcomes and objective measures of physical activity or sedentary time with a wearable Fitbit. Additionally, we will examine the associations between movement, pain acceptance, and related health factors, such as pain severity, sleep, functional status, depression, and anxiety. The addition of biometric data will allow for further investigation of the association between objective measures and patient self-report measures.
Detailed description
Chronic pain has high impact on societal function as well as an individual person's mood, physical function, disability, and quality of life and their health. The purpose of the study is to collect objective outcome measures on movement, activity, biometrics and patient reported outcome measures for participants of behavioral treatment groups of 6-8 weeks duration at Stanford Pain Management Center. Group participants learn skills and develop a personalized plan to use the skills throughout the program. The study will follow participants with a removable wearable device on the wrist for 2 weeks pre group to establish movement activity baselines, during the group intervention (6-8 weeks) and 2 weeks post group to determine which groups have benefits across various aspects of health including: sleep, psychological processes of pain acceptance, physical mobility, quality of life and the impact of supervised movement and physical activity in the treatment groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral Group Treatment (Cognitive Behavioral Therapy CBT + Movement) | – | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy Group led by a psychologist to learn pain coping skills, with gentle movement component of duration from 45 minutes to 60 minutes under a licensed Healthcare provider (PT or OT). |
| Behavioral Group Treatment (ACT) only | – | Behavioral: Acceptance and Commitment Therapy (ACT)Acceptance and Commitment Therapy Group led by a psychologist to learn skills to change their relationship with pain to decrease pain's impact on their life. |
| Behavioral Group Treatment (ACT + Movement)- Back in ACTion | – | Behavioral: Acceptance and Commitment Therapy (ACT), Behavioral: Moderate to high Intensity Group ExerciseAcceptance and Commitment Therapy Group led by a psychologist to learn skills to change their relationship with pain to decrease pain's impact on their life and improve willingness to engage in valued activities. Movement component to last from with intense and gentle movement sessions with a total movement time of 90 minutes - 2 hours led by licensed health care provider a PT or OT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with chronic pain
Key inclusion criteria (4 listed)
- Age 18+
- Non-cancer chronic pain (pain that occurs on at least half of the days of 6 months or more)
- English fluency
- Ability to attend >70% treatment sessions to ensure active treatment is delivered
Key exclusion criteria (7 listed)
- Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
- Participants with acute cauda equina syndrome
- Inability to complete a 6 minute walk test without LOB
- 3) Chronic pain as explained by inflammatory disease
- Exclusion: For our CBT + Movement (low intensity/ restorative) movement group: Patient must be able to sit upright for 20 minutes without loss of balance or upper extremity (UE) assistance. Inability to sit without use of UE support would be excluded. This ensures safety that the participant can completed the adapted movement program without risk of falls. HR will not be elevated > 50% HRmax in these restorative movement classes.
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 |
|---|---|---|
| Cognitive Behavioral TherapyAlso: Pain Coping Skills, Group MovementThe participants will attend one of the behavioral group treatments programs offered by the Stanford Pain Management Center. This class may be held online via Zoom, or in person based at the Stanford Pain Management Center. The class may be recorded for training purposes. No names or images/faces will be recorded for privacy reasons. The behavioral groups are 3 types, with or without exercise/movement. Current Evidence Based treatments that are provided as standard practice include: Cognitive Behavioral Therapy Group, with movement, Acceptance and Commitment Therapy Group, with or without movement. Group participants will learn different skills in each group and develop a personalized plan to use the skills after group ends. At the end of group participants will be given an anonymous survey about the class to evaluate satisfaction of the treatment. Movement in this portion of class is designed to low impact and restorative/gentle, with no significant increases in HR > 50% HRmax. | Behavioural | Behavioral Group Treatment (Cognitive Behavioral Therapy CBT + Movement) |
| Acceptance and Commitment Therapy (ACT)ACT is a 6 week behavioral group program led by a psychologist to improve psychological flexibility and reduce pain interference in patients with chronic pain. | Behavioural | Behavioral Group Treatment (ACT + Movement)- Back in ACTion, Behavioral Group Treatment (ACT) only |
| Moderate to high Intensity Group ExerciseGroup exercise led by supervised clinician with Cardiovascular focus to increase HR into zones to see adaptations to improve cardiovascular fitness. | Behavioural | Behavioral Group Treatment (ACT + Movement)- Back in ACTion |
Primary outcome
Change in sedentary behavior time
Time frame: Pre intervention (baseline), and post intervention (at 10 weeks)
Sedentary behavior is defined as any waking behavior such as sitting or leaning with an energy expenditure of 1.5 metabolic equivalent task (MET) or less
12 secondary outcomes
HF-Heart rate variability
Time frame: Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
Sleep Duration
Time frame: Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
Daily Step Count
Time frame: Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
Pain Catastrophizing
Time frame: Pre intervention (baseline), and post intervention (at 10 weeks) and 6 months follow up (post group)
PROMIS Depression Score
Time frame: Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
PROMIS Anxiety Score
Time frame: Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
PROMIS Sleep Disturbance Score
Time frame: Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
PROMIS Physical Function Score
Time frame: Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
PROMIS Pain Interference Score
Time frame: Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
Duration of Heart Rate in Exercise Zones (50-70% HRMax) (during exercise)
Time frame: Pre intervention (baseline), and post intervention (at 10 weeks)
Average Resting Heartrate
Time frame: Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
Physical Activity Vital Sign
Time frame: Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Background: PubMed 34151829You DS, Ziadni MS, Cooley CE, Talavera DC, Mackey SC, Poupore-King H. Effectiveness of a multidisciplinary rehabilitation program in real-world patients with chronic back pain: A pilot cohort data analysis. J Back Musculoskelet Rehabil. 2021;34(6):965-973. doi: 10.3233/BMR-200305.
- Background: PubMed 35754259Neumann A, Hampel P. Long-term effects of rehabilitation and prevention of further chronification of pain among patients with non-specific low back pain. J Back Musculoskelet Rehabil. 2022;35(6):1257-1268. doi: 10.3233/BMR-210221.
- Background: PubMed 32036768Pears S, Sutton S. Effectiveness of Acceptance and Commitment Therapy (ACT) interventions for promoting physical activity: a systematic review and meta-analysis. Health Psychol Rev. 2021 Mar;15(1):159-184. doi: 10.1080/17437199.2020.1727759. Epub 2020 Feb 17.
- Background: PubMed 27122452Mercer K, Li M, Giangregorio L, Burns C, Grindrod K. Behavior Change Techniques Present in Wearable Activity Trackers: A Critical Analysis. JMIR Mhealth Uhealth. 2016 Apr 27;4(2):e40. doi: 10.2196/mhealth.4461.
- Background: PubMed 29034226Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.
- Background: PubMed 36745187Karayannis NV, Sturgeon JA, Kemani MK, Mackey SC, Greco CM, Wicksell RK, McCracken LM. Pain acceptance and psychological inflexibility predict pain interference outcomes for persons with chronic pain receiving pain psychology. Scand J Pain. 2023 Feb 7;23(3):464-475. doi: 10.1515/sjpain-2022-0107. Print 2023 Jul 26.
- 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. This study is not recruiting at the moment.
Heather King, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Sedentary Time, run by Stanford 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 May 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?
Results are not available in the source record.
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?
Change in sedentary behavior time (time frame: Pre intervention (baseline), and post intervention (at 10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05812703, which also lists 6 linked publications.
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 7 May 2024.