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Completed

NCT Number: NCT06804239

Improving Activity in Adults With Chronic Pain 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.

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Key information

Conditions

Chronic Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington State University, Spokane, Washington, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

User guide with prompts

Behavioral

A user guide and prompts to assist use of an Online Pain-Management Resource

Primary outcomes

  1. Activity

    Time frame: 8 weeks

    Changes in activity as recorded on wearable activity tracker (Fitbit Inspire 3®)

  2. Sleep

    Time frame: 8 weeks

    Changes in sleep as recorded on wearable activity tracker (Fitbit Inspire 3®)

Secondary outcomes

  1. Pain intensity

    Time frame: 8 weeks

    Patient reported outcomes measurement information system (PROMIS) Pain Intensity measures 1a and 3A where higher value means worse pain (1-5 rating).

  2. Pain Interference

    Time frame: 8 weeks

    Patient reported outcomes measurement information system (PROMIS) Pain Interference 8 item measure where higher value means worse pain (1-5 rating)

  3. Chronic Pain Acceptance

    Time frame: 8 weeks

    Chronic Pain Acceptance Questionnaire is 14 items where 0=never true and 6=always true and higher scores indicate greater acceptance.

  4. Kinesiophobia

    Time frame: 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.

  5. Sleep disturbance

    Time frame: 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.

  6. System Usability

    Time frame: 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.

  7. Client Satisfaction

    Time frame: 8 weeks

    Pain hub client satisfaction 8-item questionnaire rating items 1-4 where higher scores indicate greater satisfaction.

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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