Clinical trial NCT05812703: Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Pain
Sedentary Time
Keywords: movement
behavioral treatments
biometrics
chronic pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with chronic pain

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in sedentary behavior time
timeFrame: Pre intervention (baseline), and post intervention (at 10 weeks)
Secondary outcomes:
measure: HF-Heart rate variability
timeFrame: Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
measure: Sleep Duration
timeFrame: Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
measure: Daily Step Count
timeFrame: Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
measure: Pain Catastrophizing
timeFrame: Pre intervention (baseline), and post intervention (at 10 weeks) and 6 months follow up (post group)
measure: PROMIS Depression Score
timeFrame: Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
measure: PROMIS Anxiety Score
timeFrame: Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
measure: PROMIS Sleep Disturbance Score
timeFrame: Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
measure: PROMIS Physical Function Score
timeFrame: Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
measure: PROMIS Pain Interference Score
timeFrame: Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
measure: Duration of Heart Rate in Exercise Zones (50-70% HRMax) (during exercise)
timeFrame: Pre intervention (baseline), and post intervention (at 10 weeks)
measure: Average Resting Heartrate
timeFrame: Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
measure: Physical Activity Vital Sign
timeFrame: Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Pain Management Clinic
state: California
Study officials:
affiliation: Stanford University
name: Heather King, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Neumann 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.
citation: Pears 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.
citation: Mercer 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.
citation: Shaffer 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.
citation: Karayannis 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.