Management of Chronic Pain

Digital Self-Management of Chronic Pain

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Digital Pain-Management Tool

Detailed Description

Chronic pain is today an increasing health problem in both Europe and US, with an estimation of about 90 million people affected in Europe (Breivik, H. et al., 2006) and 100 million people in US (Relieving Pain in America, IOM Report 2011), or 20-30% of the adult population around the world. Chronic pain is defined as a condition that lasts for at least three to six months, after the normal healing period of an injury. Medical interventions offered in clinics around the globe are unfortunately not giving the results needed to give back the quality of life the patients had prior to the onset of the pain. The treatments offered today do sometimes reduce pain, but the effect is minor, and new treatment regimens are needed (Relieving Pain in America, 2011). Recent quality assurance registry measurements in Sweden has shown that patient taken part of multi modal treatment regimens, such as the acceptance and commitment therapy, (ACT) show that less then 40% of the patients have a decline in the pain level of 1 level on the VAS scale, 55% has no effect and 9 % has an increased level of pain after going through the program (Nationel Register for Pain Rehabilitation, Sweden 2017) The study objective is to evaluate how the use of a digital pain coach, based on artificial intelligence that improves the self-management of pain will decrease the pain interference and thereby increase QoL among chronic pain patients, as measured by PROMIS pain interference 6a. We will here compare the improvement of quality of life by a decrease in pain interference, measured by PROMIS, in patients who follow their traditional treatment plan provided by the Pain Clinic with the addition of using a web application for increased self management of pain. The theory behind the study and the development of the device is supported by previously known data, showing that self-management has an effect and is important to the treatment by helping patients to believe in their own capacity to control their pain.

The present investigation aims at exploring the effect of including digital tool as an add on to standard treatment and rehabilitation and will measure the effect it has on:

1. Decreased pain interference
2. Improved management of long-term pain and its consequences. Hence self-management of pain
3. Increased function in daily life with the best possible activity and participation level
4. Improved experience of health-related quality of life
5. Decreased pain experience

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Newton, Massachusetts, United States, 02459
      • Newton-Wellesley Hospital- Ambulatory Pain Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

18 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain severity	Change from Baseline in the 7 day average pain intensity. Measured by NRS using an 11-point Pain Intensity Numerical Rating Scale (NRS) (0=no pain, 10=pain as bad as you can imagine)	6 and 12 weeks from baseline
Physical function	Change from baseline in physical function, measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Physical function 10a. Measure of the impact of a condition on physical function; range 4-20; higher is worse	6 and 12 weeks from baseline
Depression	Change from Baseline measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression 4a. Measures the extent to which patients experience depressive symptoms over the past 7 days. Raw scores range from 4-20 with lower scores representing less endorsement of depression	6 and 12 weeks from baseline
Anxiety	Change from Baseline measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety 4. Measures the extent to which patients experience anxiety symptoms over the past 7 days. Raw scores range from 4-20 with lower scores representing less endorsement of anxiety.	6 and 12 weeks from baseline
Pain Catastrophizing	The Pain Catastrophizing Scale (PCS) is a 13-item self-administered scale and one of the most widely used to assess pain catastrophizing The theoretical range of the instrument is between 0 and 52, with low scores indicating low catastrophizing, and high values showing high catastrophizing.	6 and 12 weeks from baseline
Chronic Pain Acceptance	Chronic Pain Acceptance Questionnaire-8 (CPAQ-8) CPAQ-8 is an 8-question survey that measures the level of patient acceptance of pain. The scale ranges from 0-48 and where a higher scores corresponds to greater acceptance of pain.	6 and 12 weeks from baseline

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: Newton-Wellesley Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2021
• Primary Completion (ACTUAL): May 1, 2022
• Study Completion (ACTUAL): August 1, 2022

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (ACTUAL): April 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: self management; e-health; health tech; Digital Pain-Management Tool
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: US3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No