Improving Activity in Adults With Chronic Pain With Online Resources

Improving Activity in Adults With Chronic Pain: Self-Directed Versus Guided Support With Online Resources

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: User guide with prompts

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99202
      • Washington State University
    • Spokane, Washington, United States, 99201
      • Washington State University College of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention group will receive a User Guide and weekly prompts with access to an Online Pain-Management Resource	Behavioral: User guide with prompts; A user guide and prompts to assist use of an Online Pain-Management Resource
Active Comparator: Active-control; The active-control group receives access to the Online Pain-Management Resource, but no User Guide or prompts.	Behavioral: User guide with prompts; A user guide and prompts to assist use of an Online Pain-Management Resource

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity	Changes in activity as recorded on wearable activity tracker (Fitbit Inspire 3®)	8 weeks
Sleep	Changes in sleep as recorded on wearable activity tracker (Fitbit Inspire 3®)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Patient reported outcomes measurement information system (PROMIS) Pain Intensity measures 1a and 3A where higher value means worse pain (1-5 rating).	8 weeks
Pain Interference	Patient reported outcomes measurement information system (PROMIS) Pain Interference 8 item measure where higher value means worse pain (1-5 rating)	8 weeks
Chronic Pain Acceptance	Chronic Pain Acceptance Questionnaire is 14 items where 0=never true and 6=always true and higher scores indicate greater acceptance.	8 weeks
Kinesiophobia	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.	8 weeks
Sleep disturbance	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.	8 weeks
System Usability	Pain hub system usability scale 10 items rating 1-5 about the ease of system use. Higher scores are more favorable usability ratings.	8 weeks
Client Satisfaction	Pain hub client satisfaction 8-item questionnaire rating items 1-4 where higher scores indicate greater satisfaction.	8 weeks

Collaborators and Investigators

• Sponsor: Washington State University

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2025
• Primary Completion (Actual): August 28, 2025
• Study Completion (Actual): August 28, 2025

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Chronic pain; Activity; Online resources
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Chronic Pain; Motor Activity
• Other Study ID Numbers: 20809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Interested persons can contact the PI for deidentified data
• IPD Sharing Time Frame: After study ends for 3 years
• IPD Sharing Access Criteria: People with a scientific rationale for requesting the information
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No