Self-Management of Chronic Pain

NCT04837794 | Completed

• 1 other identifier: US1
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to validate if a digital tool for increased self-management of chronic pain can improve the quality of life for patients with chronic pain. The validation is based on the change in pain interference (Quality of life), pain intensity, physical functioning, depression, and anxiety based on self-reported information from baseline to study end.

Conditions

Chronic Pain

Keywords

self management; e-health; health tech; Digital Pain-Management Tool

Outcome Measures

Primary Outcomes (1)

• Pain interference

  Change from baseline in pain interference (QoL), measured by PROMIS Pain Interference 6a . Measure of the amount of interference pain causes in life; range 6-30; higher is worse

  6 and 12 weeks from baseline

Secondary Outcomes (4)

• Pain severity

  6 and 12 weeks from baseline

• Physical function

  6 and 12 weeks from baseline

• Depression

  6 and 12 weeks from baseline

• Anxiety

  6 and 12 weeks from baseline

Interventions

Digital Pain-Management Tool DEVICE

Digital Pain-Management Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with chronic pain patients at the UCSD Health System- Center for pain Medicine

You may qualify if:

• Have a complex, prolonged (neck shoulder pain or lower back pain
• Have been followed by a pain management specialist for at least 6 months
• Referred for Pain Medicine Consultation
• Be \>18 years of age
• Be able to travel to and from the clinic
• Have a goal and motivation that is adequate in relation to the program offered
• Be medically prepared and not have any other medical examination or ongoing disease that constitutes an obstacle as well as adequate pharmacological treatment
• Have no major change in pain management (e.g. medications)
• Own a smart phone, tablet or computer or have the knowledge to use one

You may not qualify if:

• Low back pain requiring surgical intervention in the next 3 months
• Severe or acute psychiatric illness, severe anxiety or depression
• Reported/acute psychiatric illness or acute crisis
• Ongoing abuse of alcohol, drugs and drug-based drugs. This also includes high doses of prescribed drugs
• Pain related to malignancy
• Other areas of pain exceeding the level/intensity of low back or neck pain
• Currently involved in a lawsuit or pending litigation in relation to the low back or neck pain

Sponsors & Collaborators

• Lund University: lead
• University of California, San Diego: collaborator
• PainDrainer AB: collaborator

Study Sites (1)

UC San Diego Health - Koman Family Outpatient Pavilion

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory R Polston, MD

  UC San Diego Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: August 1, 2019
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)