What Objective Changes Occur With Behavioral Treatment: Evaluating Biometrics and Self -Reported Health Measures of Adult Patients Receiving Behavioral Treatments With Chronic Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Stanford University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in sedentary behavior time
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Heather Poupore-King
Clinical Associate Professor
Stanford University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Sleep Duration(Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks))
- Pain Catastrophizing(Pre intervention (baseline), and post intervention (at 10 weeks) and 6 months follow up (post group))
- PROMIS Depression Score(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)(Pre intervention (baseline), and post intervention (at 10 weeks))
- PROMIS Anxiety Score(Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group))
- PROMIS Physical Function Score(Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group))
- Daily Step Count(Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks))
- PROMIS Sleep Disturbance Score(Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group))
- Average Resting Heartrate(Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks))
- HF-Heart rate variability(Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks))
- PROMIS Pain Interference Score(Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group))
- Physical Activity Vital Sign(Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks))