Improving Activity in Adults With Chronic Pain With Online Resources

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain

• Registration Number: NCT06804239
• Lead Sponsor: Washington State University

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.

Study Timeline

• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Study First Posted: 2025-02-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-07
• Study Start: 2025-04-10
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Activity	8 weeks	Changes in activity as recorded on wearable activity tracker (Fitbit Inspire 3®)
Sleep	8 weeks	Changes in sleep as recorded on wearable activity tracker (Fitbit Inspire 3®)

Secondary Outcome Measures

Name	Time	Method
Pain intensity	8 weeks	Patient reported outcomes measurement information system (PROMIS) Pain Intensity measures 1a and 3A where higher value means worse pain (1-5 rating).
Pain Interference	8 weeks	Patient reported outcomes measurement information system (PROMIS) Pain Interference 8 item measure where higher value means worse pain (1-5 rating)
Chronic Pain Acceptance	8 weeks	Chronic Pain Acceptance Questionnaire is 14 items where 0=never true and 6=always true and higher scores indicate greater acceptance.
Kinesiophobia	8 weeks	Tampa Scale of Kinesiophobia 17 items measures fear of movement and pain where 1=strongly disagree and 4=strongly agree. Higher scores indicate greater fear of movement and pain. A score of 37 or higher is often considered indicative of clinically significant kinesiophobia.
Sleep disturbance	8 weeks	Patient reported outcome measurement information system (PROMIS) Sleep Disturbance Short Form 4a where 5= Very poor or not at all and 1= very good or very much. Higher scores indicate increased sleep disturbance.
System Usability	8 weeks	Pain hub system usability scale 10 items rating 1-5 about the ease of system use. Higher scores are more favorable usability ratings.
Client Satisfaction	8 weeks	Pain hub client satisfaction 8-item questionnaire rating items 1-4 where higher scores indicate greater satisfaction.

Trial Locations

Locations (1)

Washington State University; 🇺🇸 Spokane, Washington, United States