Clinical trial NCT05213468: Self-management of Chronic Pain Though E-health
Official title: Self-management of Chronic Pain Through the Use of the Digital Tool PainDrianer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Keywords: self management
e-health
health tech
Digital Pain-Management Tool
Lead sponsor: PainDrainer AB
Sponsor class: INDUSTRY
Collaborators: name: Skane University Hospital
name: Lund University
First posted: 2022-01-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel study, single blinded
Primary purpose: TREATMENT

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 and 100 million people in US, 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. 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. 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. This study will 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 at the physiotherapy program at the clinic 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:

* Have a pain condition that requires analysis and rehabilitation at a specialist clinic
* \>18 years of age
* Be medically investigated, with adequate pharmacological treatment, and do not have any other medical examination or ongoing illness that hinders participation in the physiotherapy program at VO Neurosurgery and Pain rehabilitation, Skåne University Hospital, Lund
* Meet the criteria for inclusion in the physiotherapy program: Have a chronic (\> 3 months) state of pain with local, regional or spread location, where the pain is judged to be reduced by physiotherapeutic measures
* Being included in the physiotherapy program, at VO Neurosurgery and Pain rehabilitation, Skåne University Hospital, Lund
* Have the knowledge and proficiency to use a smart phone, tablet or computer

Exclusion Criteria:

* Severe or acute psychiatric illness, severe anxiety or depression

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: Fatigue
timeFrame: 6 and 12 weeks from baseline
measure: Sleep disturbance
timeFrame: 6 and 12 weeks from baseline
measure: Ability to Participate in Social Roles and Activities
timeFrame: 6 and 12 weeks from baseline
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: VO Neurokirurgi och Smärtrehabilitering Skånes universitetssjukhus
Study officials:
affiliation: VO Neurosurgery and Pain rehabilitation, Skåne University Hospital, Lund
name: Marcelo Rivano Fischer, Clin.Psy.D
role: PRINCIPAL_INVESTIGATOR
References: