Chronic Pain
Conditions
Keywords
Chronic pain, Activity, Online resources
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.
Interventions
BEHAVIORALUser guide with prompts
A user guide and prompts to assist use of an Online Pain-Management Resource
Sponsors
Washington State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
| 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) |
Countries
United States
Outcome results
None listed