NCT06804239

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

April 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

January 28, 2025

Last Update Submit

September 16, 2025

Conditions

Chronic Pain

Keywords

Chronic painActivityOnline resources

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Pain intensity

    8 weeks

  • Pain Interference

    8 weeks

  • Chronic Pain Acceptance

    8 weeks

  • Kinesiophobia

    8 weeks

  • Sleep disturbance

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive a User Guide and weekly prompts with access to an Online Pain-Management Resource

Behavioral: User guide with prompts

Active-control

ACTIVE COMPARATOR

The active-control group receives access to the Online Pain-Management Resource, but no User Guide or prompts.

Behavioral: User guide with prompts

Interventions

User guide with promptsBEHAVIORAL

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

Active-controlIntervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Washington State University College of Nursing

Spokane, Washington, 99201, United States

Location

Washington State University

Spokane, Washington, 99202, United States

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Chronic PainMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 3, 2025

Study Start

April 20, 2025

Primary Completion

August 28, 2025

Study Completion

August 28, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Interested persons can contact the PI for deidentified data

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After study ends for 3 years
Access Criteria
People with a scientific rationale for requesting the information
More information

Locations

US(2)