Self-management of Chronic Pain Though E-health
Primary Purpose
Chronic Pain
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
PainDrainerTM
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring self management, e-health, health tech, Digital Pain-Management Tool
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
Sites / Locations
- VO Neurokirurgi och Smärtrehabilitering Skånes universitetssjukhus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Self management app as add on to standard care
Standard of care
Arm Description
PainDrainerTM App as add on to standard treatment at the physiotherapy program at the clinic PainDrainer software application: PainDrainerTM app (version 1.1.19c). ' The PainDrainer app is an investigational device, intended as a digital aid for the self-management of chronic pain for use by adults without supervision by healthcare professionals in a home setting.
Treatment as usual, standard treatment of care at the physiotherapy program at the clinic
Outcomes
Primary Outcome Measures
Pain interference
Change from baseline in pain interference (QoL), measured by PROMIS Pain Interference 4a . Measure of the amount of interference pain causes in life; range 4-20; higher is worse
Secondary Outcome Measures
Pain severity
Change from Baseline in the 7 day average pain intensity. Measured by NRS using Pain Intensity Numerical Rating Scale (NRS) (0=no pain, 10=pain as bad as you can imagine)
Physical function
Change from baseline in physical function, measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Physical function 4a.
Measure of the impact of a condition on physical function; range 4-20; Raw scores range from 4-20 with higher scores represent better functioning.
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 higher scores represent worse symptomatology.
Anxiety
Change from Baseline measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety 4a.
Measures the extent to which patients experience anxiety symptoms over the past 7 days. Raw scores range from 4-20 higher scores represent worse symptomatology.
Fatigue
Change from Baseline measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 4a Measures the extent to which patients experience fatigue symptoms over the past 7 days. Raw scores range from 4-20 with higher scores represent worse symptomatology.
Sleep disturbance
Change from Baseline measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance 4a Measures the extent to which patients experience Sleep disturbance over the past 7 days. Raw scores range from 4-20 with higher scores represent worse symptomatology.
Ability to Participate in Social Roles and Activities
Change from Baseline measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities 4a. Measures the extent to which patients ability to participate in social roles and activities over the past 7 days. Raw scores range from 4-20 with higher scores represent better functioning.
Full Information
NCT ID
NCT05213468
First Posted
January 5, 2022
Last Updated
June 12, 2023
Sponsor
PainDrainer AB
Collaborators
Skane University Hospital, Lund University
1. Study Identification
Unique Protocol Identification Number
NCT05213468
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
A change in patient population at the clinical trial site has occurred due to the pandemic, resulting in too few patients for the physiotherapy program to conduct the study.
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PainDrainer AB
Collaborators
Skane University Hospital, Lund University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Decreased pain interference
Improved management of long-term pain and its consequences. Hence self management of pain
Increased function in daily life with the best possible activity and participation level
Improved experience of health-related quality of life
Decreased pain experience
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
self management, e-health, health tech, Digital Pain-Management Tool
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel study, single blinded
Masking
Care Provider
Masking Description
Parallel study, single blinded
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self management app as add on to standard care
Arm Type
Experimental
Arm Description
PainDrainerTM App as add on to standard treatment at the physiotherapy program at the clinic PainDrainer software application: PainDrainerTM app (version 1.1.19c). ' The PainDrainer app is an investigational device, intended as a digital aid for the self-management of chronic pain for use by adults without supervision by healthcare professionals in a home setting.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Treatment as usual, standard treatment of care at the physiotherapy program at the clinic
Intervention Type
Device
Intervention Name(s)
PainDrainerTM
Intervention Description
Self management digital tool for chronic pain
Primary Outcome Measure Information:
Title
Pain interference
Description
Change from baseline in pain interference (QoL), measured by PROMIS Pain Interference 4a . Measure of the amount of interference pain causes in life; range 4-20; higher is worse
Time Frame
6 and 12 weeks from baseline
Secondary Outcome Measure Information:
Title
Pain severity
Description
Change from Baseline in the 7 day average pain intensity. Measured by NRS using Pain Intensity Numerical Rating Scale (NRS) (0=no pain, 10=pain as bad as you can imagine)
Time Frame
6 and 12 weeks from baseline
Title
Physical function
Description
Change from baseline in physical function, measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Physical function 4a.
Measure of the impact of a condition on physical function; range 4-20; Raw scores range from 4-20 with higher scores represent better functioning.
Time Frame
6 and 12 weeks from baseline
Title
Depression
Description
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 higher scores represent worse symptomatology.
Time Frame
6 and 12 weeks from baseline
Title
Anxiety
Description
Change from Baseline measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety 4a.
Measures the extent to which patients experience anxiety symptoms over the past 7 days. Raw scores range from 4-20 higher scores represent worse symptomatology.
Time Frame
6 and 12 weeks from baseline
Title
Fatigue
Description
Change from Baseline measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 4a Measures the extent to which patients experience fatigue symptoms over the past 7 days. Raw scores range from 4-20 with higher scores represent worse symptomatology.
Time Frame
6 and 12 weeks from baseline
Title
Sleep disturbance
Description
Change from Baseline measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance 4a Measures the extent to which patients experience Sleep disturbance over the past 7 days. Raw scores range from 4-20 with higher scores represent worse symptomatology.
Time Frame
6 and 12 weeks from baseline
Title
Ability to Participate in Social Roles and Activities
Description
Change from Baseline measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities 4a. Measures the extent to which patients ability to participate in social roles and activities over the past 7 days. Raw scores range from 4-20 with higher scores represent better functioning.
Time Frame
6 and 12 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Rivano Fischer, Clin.Psy.D
Organizational Affiliation
VO Neurosurgery and Pain rehabilitation, Skåne University Hospital, Lund
Official's Role
Principal Investigator
Facility Information:
Facility Name
VO Neurokirurgi och Smärtrehabilitering Skånes universitetssjukhus
City
Lund
ZIP/Postal Code
21428
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
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Self-management of Chronic Pain Though E-health
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