E-health for Self-Management of Chronic Pain

NCT04628650 | Completed

• 1 other identifier: US2
• Study Type: observational
• Target: 30
• 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

chronic pain; 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

Self management digital tool for chronic pain

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 Joan and Sanford I. Weill Medical College of Cornell University - A specialist clinic for pain therapy.

You may qualify if:

• Have a complex, prolonged axial neck pain or lower back pain
• Have been followed by a pain management specialist for at least 3 months or have a history of chronic pain for at least 3 months as recorded by physician
• Be \>18 years of age
• Have a goal and motivation that is adequate in relation to the program offered
• Be medically prepared
• Have no major change in interventional treatment or be a surgical candidate
• Own a smart phone, tablet or computer or have the knowledge to use one

You may not qualify if:

• Chronic pain requiring imminent surgical intervention
• Reported severe or acute psychiatric illness, severe anxiety or depression
• Current history of substance abuse
• Serious health risks or scheduled major health interventions for other medical reasons
• Pain related to malignancy
• Pain duration \<3 months
• Other areas of pain exceeding the amount of back or neck pain
• Not currently involved in lawsuit or pending litigation

Sponsors & Collaborators

• Lund University: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Neel Metha, MD

  Weill Cornell Medicine, Department of Anesthesiology

  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: November 10, 2020
• First Posted: November 13, 2020
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)