Clinical trial NCT06804239: Improving Activity in Adults With Chronic Pain With Online Resources
Official title: Improving Activity in Adults With Chronic Pain: Self-Directed Versus Guided Support With Online Resources
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain
Activity
Online resources
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled study will test whether adults with chronic pain have improved outcomes when receiving a User Guide and weekly prompts for a newly designed Online Pain-Management Resource when compared to an active-control group that receives access to the Online Pain-Management Resource, but no User Guide or prompts. Outcomes of interest include measures of activity, sleep, pain and level of use of the online pain-management resource.

Detailed description: Participants with chronic pain will be randomized in this pilot study to an intervention group that receives a User Guide and weekly prompts to use an Online Pain-Management Resource or an active-control group that receives access to the Online Pain-Management Resource, but no User Guide or prompts. Outcomes of interest include:

i. Changes in activity and sleep over time when online resources are paired with using a wearable activity tracker (Fitbit Inspire 3®); ii. Self-reported pain and pain-related measures; and iii. Level of use of the online pain-management resource. All participants will also be asked to provide feedback on the online pain-management resource. The information collected throughout the study will inform the development team on the website's usefulness and whether guided use is superior to unguided self-directed use of the online pain resource.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* chronic pain at least 3 months
* interested in increasing activity level
* able to read and speak English
* reside within US
* willing to have activity tracker shipped to address
* able to download Fitbit app onto phone or computer
* willing to use Fitbit device for most days and nights during 8 weeks study

Exclusion Criteria:

* medical or psychological conditions that would prevent study participation
* planned surgery or procedure that would prevent study participation

Primary outcomes:
measure: Activity
timeFrame: 8 weeks
measure: Sleep
timeFrame: 8 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: 8 weeks
measure: Pain Interference
timeFrame: 8 weeks
measure: Chronic Pain Acceptance
timeFrame: 8 weeks
measure: Kinesiophobia
timeFrame: 8 weeks
measure: Sleep disturbance
timeFrame: 8 weeks
measure: System Usability
timeFrame: 8 weeks
measure: Client Satisfaction
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Washington State University
state: Washington
Study officials:
References:
citation: Ruehlman, L.S., Bindler, R.J., Rangel, T.L. et al. Perspectives of Adults with Pain Regarding Online Pain Self-Management Resources. J. technol. behav. sci. (2024). https://doi.org/10.1007/s41347-024-00433-7