Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain

Not yet recruiting

• Conditions: Chronic Pain; Sedentary Time

• Registration Number: NCT05812703
• Lead Sponsor: Stanford University

Brief 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. 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 Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Study Start: 2024-09-27
• Primary Completion: 2025-10-25
• Study Completion: 2026-04-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age 18+
2. Non-cancer chronic pain (pain that occurs on at least half of the days of 6 months or more)
3. English fluency
4. Ability to attend >70% treatment sessions to ensure active treatment is delivered

Exclusion Criteria

1. Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
2. Participants with acute cauda equina syndrome
3. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in sedentary behavior time	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

Secondary Outcome Measures

Name	Time	Method
Sleep Duration	Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)	Amount of time asleep per "night cycle"
Pain Catastrophizing	Pre intervention (baseline), and post intervention (at 10 weeks) and 6 months follow up (post group)	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.
PROMIS Depression Score	Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)	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.
Duration of Heart Rate in Exercise Zones (50-70% HRMax) (during exercise)	Pre intervention (baseline), and post intervention (at 10 weeks)	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.
PROMIS Anxiety Score	Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)	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.
PROMIS Physical Function Score	Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)	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.
Daily Step Count	Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)	Amount of steps occurring in a 24 hour day
PROMIS Sleep Disturbance Score	Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)	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.
Average Resting Heartrate	Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)	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.
HF-Heart rate variability	Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)	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.
PROMIS Pain Interference Score	Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)	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.
Physical Activity Vital Sign	Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)	the subjective measure of minutes a person is physically active in a week (in minutes)

Trial Locations

Locations (1)

Stanford Pain Management Clinic; 🇺🇸 Redwood City, California, United States