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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05812703
Other study ID # 66952
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 27, 2024
Est. completion date April 25, 2026

Study information

Verified date May 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date April 25, 2026
Est. primary completion date October 25, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive Behavioral Therapy
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)
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 Exercise
Group exercise led by supervised clinician with Cardiovascular focus to increase HR into zones to see adaptations to improve cardiovascular fitness.

Locations

Country Name City State
United States Stanford Pain Management Clinic Redwood City California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pre intervention (baseline), and post intervention (at 10 weeks)
Secondary 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. Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
Secondary Sleep Duration Amount of time asleep per "night cycle" Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
Secondary Daily Step Count Amount of steps occurring in a 24 hour day Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
Secondary 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. Pre intervention (baseline), and post intervention (at 10 weeks) and 6 months follow up (post group)
Secondary 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. Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
Secondary 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. Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
Secondary 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. Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
Secondary 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. Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
Secondary 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. Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)
Secondary 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.
Pre intervention (baseline), and post intervention (at 10 weeks)
Secondary 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.
Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
Secondary Physical Activity Vital Sign the subjective measure of minutes a person is physically active in a week (in minutes) Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)
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