Clinical trial NCT04865263: Management of Chronic Pain
Official title: Digital Self-Management of Chronic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: self management
e-health
health tech
Digital Pain-Management Tool
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Newton-Wellesley Hospital
First posted: 2021-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Pain interference
timeFrame: 6 and 12 weeks from baseline
Secondary outcomes:
measure: Pain severity
timeFrame: 6 and 12 weeks from baseline
measure: Physical function
timeFrame: 6 and 12 weeks from baseline
measure: Depression
timeFrame: 6 and 12 weeks from baseline
measure: Anxiety
timeFrame: 6 and 12 weeks from baseline
measure: Pain Catastrophizing
timeFrame: 6 and 12 weeks from baseline
measure: Chronic Pain Acceptance
timeFrame: 6 and 12 weeks from baseline
Other outcomes:
Locations:
city: Newton
country: United States
facility: Newton-Wellesley Hospital- Ambulatory Pain Service
state: Massachusetts
Study officials:
affiliation: Newton-Wellesley Hospital Pain Research Team
name: Antje Barreveld,, MD
role: PRINCIPAL_INVESTIGATOR
References: