Management of Chronic Pain

NCT04865263 | Completed

• 1 other identifier: US3
• Study Type: observational
• Target: 60
• 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 (6)

• 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

• Pain Catastrophizing

  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 Newton-Wellesley Hospital, 159 Wells Ave., Newton, MA - A specialist clinic for pain therapy.

You may qualify if:

• years of age
• \> 3 months low back or neck pain
• Average daily numeric rating scale (NRS) score of 4 in the low back or neck Back or neck pain is the primary area of pain (NRS scores \< 4 in other areas of pain)
• Agree to using the web-based application on a daily basis for 12 weeks
• No anticipated plans for back or neck surgery for at least 6 months
• Have the knowledge and proficiency and access to use a smart phone, tablet or computer in the English language
• Physically able to engage in basic physical activity (e.g. ambulation, light exercise, physical therapy exercises, etc.)
• Agree to remain on stable doses of medication and a stable treatment regimen

You may not qualify if:

• Low back pain requiring surgical intervention in the next 6 months
• Severe or acute psychiatric illness, severe anxiety or depression
• Current history of substance use disorder
• Serious illness in active treatment
• 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
• Newton-Wellesley Hospital: collaborator

Study Sites (1)

Newton-Wellesley Hospital- Ambulatory Pain Service

Newton, Massachusetts, 02459, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Antje Barreveld,, MD

  Newton-Wellesley Hospital Pain Research Team

  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 26, 2021
• First Posted: April 29, 2021
• Study Start: July 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

US (1)