Chronic Pain, WidespreadEPIONCT03705104
Living Well with Chronic Pain
A study testing EPIO in people with Chronic Pain, Widespread, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The goal of this project is to test the effect of an interactive e-health intervention for people with chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Widespread
- What is being tested?
- EPIO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteNorway
- Study dates
- 3 Dec 2019to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pain (pain > 3 months)
- > 18 years of age
- Able to write/read/speak Norwegian
- Have their own smart phone, PC or tablet
Who cannot join
- Cancer related pain
- Migraine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Living Well with Chronic Pain: Using Person-centered E-health Design to Support Self-management
The goal of this project is to test the effect of an interactive e-health intervention for people with chronic pain.
Read the detailed description
Chronic pain conditions are common and difficult to cure. As much as 30% of adults in Norway experience moderate-to-severe chronic pain, i.e., pain having lasted more than 3 months. Chronic pain is also the most common cause of sick leave and disability pension in Norway. Despite a clear request from the authorities, e-health interventions for chronic pain has not yet been tested and implemented.
The aim of this study is to investigate the effect of an interactive e-health intervention for people living with chronic pain, using outcome measures such as pain intensity, pain acceptance, anxiety/depression and quality of life.
The e-health intervention will first be tested in a pilot study with 50 patients with different pain diagnoses and eventually in a randomized controlled trial with a sample of 240 patients with different pain diagnoses. The intervention will consist of one face-to-face introductory group followed by 9 app-based modules containing cognitive behavioral pain self-management material. The 9 modules will be distributed over minimum 27 days (minimum 3 days per module). The participants in the randomized controlled trial will be randomly assigned to use the e-health intervention or to a treatment as usual control group. Both groups will receive outcome measures to complete at baseline and at 3, 6 and 12 months.
Post-RCT, the EPIO study will also include a non-randomized group receiving the app-based EPIO program but without receiving an introduction session and follow up phone calls to examine potential benefits from receiving the app-based program only.
- Conditions
- Chronic Pain, Widespread
- Being tested
- EPIO
- Keywords
- Pain, Chronic Pain, Self-management, E-health, Appication, App, Intervention, Cognitive Behavioral Therapy, CBT, Acceptance and Commitment Therapy, ACT, Psychological well-being
- Medical subject headings
- Chronic Pain, Pain, Alzheimer Disease, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPIOBehavioural
Also called e-health intervention for chronic pain
App for self-management of chronic pain An app consisting of 9 modules focusing on cognitive behavioral pain self-management.
| Study group | Role | What they receive |
|---|---|---|
| EPIO (e-health intervention) | Experimental | Participants will get access to one module every third day (total 9 modules). The app consists of cognitive behavioral pain self-management material, including educational material and relaxation training exercises. Receives: Behavioral: EPIO |
| treatment as usual | No intervention | Participants will get treatment as usual during the study. All participants will get access to the app after ended study if interested. |
| Experimental without introduction group and follow up phone calls | Active comparator | One extra arm (non randomized) has been included to examine whether participants who receive the EPIO intervention without receiving an introduction session and follow up phone calls will still describe benefiting from the receiving the intervention Receives: Behavioral: EPIO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory (BPI) (Short Form) - Assessing change
9 item scale measuring pain interference on function. Using this measure, respondents rate their worst, least, average, and current pain intensity and also rate the degree to which pain interferes with 7 domains of functioning (general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life) on a scale of 0 to 10.
There is no scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference.
Measured: Baseline, and at 3, 6, and 12 months.
Secondary outcomes (6)
Pain Catastrophizing Scale (PCS) - Assessing change
13 item scale measuring helplessness, magnification and rumination. Patients rate items on a scale from 0 (not at all) to 4 (all the time). The total score range for the PCS is 0 to 52, with higher scores reflecting higher degrees of catastrophizing.
Measured: Baseline, and at 3, 6, and 12 months.
Chronic Pain Acceptance Questionnaire (CPAQ) - Assessing change
8 item scale measuring pain acceptance. It is scored on a 7-point Likert scale (0 = never true; 6 = always true). Higher scores reflect higher acceptance of pain.
Measured: Baseline, and at 3, 6, and 12 months.
Self-Regulatory Fatigue 18 (SRF-18) - Assessing change
18 item scale measuring self-regulatory capacity with cognitive, emotional, and behavioral components. Items are scored on a 5-point Likert scale (1 to 5). The obtainable score range is 18 to 90, with higher numbers reflecting higher SRF.
Measured: Baseline, and at 3, 6, and 12 months.
The Hospital Anxiety and Depression Scale (HADS) - Assessing change
14 item scale measuring anxiety and depression. Respondents are asked to indicate which of 4 response options (rated from 0-3; score range, 0-42) comes closest to describing how they have been feeling in the previous week for each item. Scores from 0-7 on the subscales are regarded as being in the normal range; a score of 11 or higher indicates a probable presence of a mood disorder, and a score of 8-10 is suggestive of the presence of the state.
Measured: Baseline, and at 3, 6, and 12 months.
System Usability Scale (SUS)
1o item scale measuring usability, with five response options for respondents; from Strongly agree to Strongly disagree. The obtainable score range is 25 to 100. A SUS score above a 68 would be considered above average and anything below 68 is below average.
Measured: At 3 months
RAND Health Related Quality of Life - Assessing change
36 item scale measuring health related quality of life. The RAND-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: Baseline, and at 3, 6, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start3 Dec 2019
- Primary completion31 Dec 2025 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Pain, WidespreadStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, University of Oslo, University College of Southeast Norway, Diakonhjemmet Hospital, Vestre Viken Hospital Trust, Drammen municipality, Norway, Mayo Clinic, University of Twente, University of Washington, University of Florida
- Responsible party
- Principal investigator, Lise Solberg Nes, Oslo University Hospital
- Investigators
- Lise Solberg Nes, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705104
- Sponsor's protocol ID
- 2018/799
- Acronym
- EPIO
- Status last verified
- Mar 2025
- First submitted
- 20 Sep 2018
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bostrom K, Borosund E, Eide H, Varsi C, Kristjansdottir OB, Schreurs KMG, Waxenberg LB, Weiss KE, Morrison EJ, Stavenes Stole H, Cvancarova Smastuen M, Stubhaug A, Solberg Nes L. Short-Term Findings From Testing EPIO, a Digital Self-Management Program for People Living With Chronic Pain: Randomized Controlled Trial. J Med Internet Res. 2023 Aug 25;25:e47284. doi: 10.2196/47284.
PubMed 37624622Bostrom K, Varsi C, Eide H, Borosund E, Kristjansdottir OB, Schreurs KMG, Waxenberg LB, Weiss KE, Morrison EJ, Nordang EF, Stubhaug A, Nes LS. Engaging with EPIO, a digital pain self-management program: a qualitative study. BMC Health Serv Res. 2022 Apr 29;22(1):577. doi: 10.1186/s12913-022-07963-x.
PubMed 35488295Eiken AG, Nordanger DO, Solberg Nes L, Varsi C. Patients' Experiences of Using an eHealth Pain Management Intervention Combined With Psychomotor Physiotherapy: Qualitative Study. JMIR Form Res. 2022 Mar 16;6(3):e34458. doi: 10.2196/34458.
PubMed 35293866Varsi C, Ledel Solem IK, Eide H, Borosund E, Kristjansdottir OB, Heldal K, Waxenberg LB, Weiss KE, Schreurs KMG, Morrison EJ, Stubhaug A, Solberg Nes L. Health care providers' experiences of pain management and attitudes towards digitally supported self-management interventions for chronic pain: a qualitative study. BMC Health Serv Res. 2021 Mar 25;21(1):275. doi: 10.1186/s12913-021-06278-7.
PubMed 33766028Bostrom K, Borosund E, Varsi C, Eide H, Flakk Nordang E, Schreurs KM, Waxenberg LB, Weiss KE, Morrison EJ, Cvancarova Smastuen M, Stubhaug A, Solberg Nes L. Digital Self-Management in Support of Patients Living With Chronic Pain: Feasibility Pilot Study. JMIR Form Res. 2020 Oct 23;4(10):e23893. doi: 10.2196/23893.
PubMed 33094734Ledel Solem IK, Varsi C, Eide H, Kristjansdottir OB, Borosund E, Schreurs KMG, Waxenberg LB, Weiss KE, Morrison EJ, Haaland-Overby M, Bevan K, Zangi HA, Stubhaug A, Solberg Nes L. A User-Centered Approach to an Evidence-Based Electronic Health Pain Management Intervention for People With Chronic Pain: Design and Development of EPIO. J Med Internet Res. 2020 Jan 21;22(1):e15889. doi: 10.2196/15889.
PubMed 31961331Ledel Solem IK, Varsi C, Eide H, Kristjansdottir OB, Mirkovic J, Borosund E, Haaland-Overby M, Heldal K, Schreurs KM, Waxenberg LB, Weiss KE, Morrison EJ, Solberg Nes L. Patients' Needs and Requirements for eHealth Pain Management Interventions: Qualitative Study. J Med Internet Res. 2019 Apr 1;21(4):e13205. doi: 10.2196/13205.
PubMed 30877780
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Well with Chronic Pain: Using Person-centered E-health Design to Support Self-management
- ClinicalTrials.gov ID
- NCT03705104
- Acronym / sponsor ID
- EPIO / 2018/799
- Conditions
- Chronic Pain, Widespread
- Keywords
- Pain, Chronic Pain, Self-management, E-health, Appication, App, Intervention, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway, University of Oslo, University College of Southeast Norway, Diakonhjemmet Hospital, Vestre Viken Hospital Trust, Drammen municipality, Norway, Mayo Clinic, University of Twente, University of Washington, University of Florida
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to test the effect of an interactive e-health intervention for people with chronic pain.
Detailed description
Chronic pain conditions are common and difficult to cure. As much as 30% of adults in Norway experience moderate-to-severe chronic pain, i.e., pain having lasted more than 3 months. Chronic pain is also the most common cause of sick leave and disability pension in Norway. Despite a clear request from the authorities, e-health interventions for chronic pain has not yet been tested and implemented.
The aim of this study is to investigate the effect of an interactive e-health intervention for people living with chronic pain, using outcome measures such as pain intensity, pain acceptance, anxiety/depression and quality of life.
The e-health intervention will first be tested in a pilot study with 50 patients with different pain diagnoses and eventually in a randomized controlled trial with a sample of 240 patients with different pain diagnoses. The intervention will consist of one face-to-face introductory group followed by 9 app-based modules containing cognitive behavioral pain self-management material. The 9 modules will be distributed over minimum 27 days (minimum 3 days per module). The participants in the randomized controlled trial will be randomly assigned to use the e-health intervention or to a treatment as usual control group. Both groups will receive outcome measures to complete at baseline and at 3, 6 and 12 months.
Post-RCT, the EPIO study will also include a non-randomized group receiving the app-based EPIO program but without receiving an introduction session and follow up phone calls to examine potential benefits from receiving the app-based program only.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EPIO (e-health intervention) | Experimental | Behavioral: EPIOParticipants will get access to one module every third day (total 9 modules). The app consists of cognitive behavioral pain self-management material, including educational material and relaxation training exercises. |
| treatment as usual | No intervention | –Participants will get treatment as usual during the study. All participants will get access to the app after ended study if interested. |
| Experimental without introduction group and follow up phone calls | Active comparator | Behavioral: EPIOOne extra arm (non randomized) has been included to examine whether participants who receive the EPIO intervention without receiving an introduction session and follow up phone calls will still describe benefiting from the receiving the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic pain (pain > 3 months)
- > 18 years of age
- Able to write/read/speak Norwegian
- Have their own smart phone, PC or tablet
Key exclusion criteria (2 listed)
- Cancer related pain
- Migraine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPIOAlso: e-health intervention for chronic painApp for self-management of chronic pain An app consisting of 9 modules focusing on cognitive behavioral pain self-management. | Behavioural | EPIO (e-health intervention), Experimental without introduction group and follow up phone calls |
Primary outcome
Brief Pain Inventory (BPI) (Short Form) - Assessing change
Time frame: Baseline, and at 3, 6, and 12 months.
9 item scale measuring pain interference on function. Using this measure, respondents rate their worst, least, average, and current pain intensity and also rate the degree to which pain interferes with 7 domains of functioning (general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life) on a scale of 0 to 10. There is no scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference.
6 secondary outcomes
Pain Catastrophizing Scale (PCS) - Assessing change
Time frame: Baseline, and at 3, 6, and 12 months.
Chronic Pain Acceptance Questionnaire (CPAQ) - Assessing change
Time frame: Baseline, and at 3, 6, and 12 months.
Self-Regulatory Fatigue 18 (SRF-18) - Assessing change
Time frame: Baseline, and at 3, 6, and 12 months.
The Hospital Anxiety and Depression Scale (HADS) - Assessing change
Time frame: Baseline, and at 3, 6, and 12 months.
System Usability Scale (SUS)
Time frame: At 3 months
RAND Health Related Quality of Life - Assessing change
Time frame: Baseline, and at 3, 6, and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 37624622Bostrom K, Borosund E, Eide H, Varsi C, Kristjansdottir OB, Schreurs KMG, Waxenberg LB, Weiss KE, Morrison EJ, Stavenes Stole H, Cvancarova Smastuen M, Stubhaug A, Solberg Nes L. Short-Term Findings From Testing EPIO, a Digital Self-Management Program for People Living With Chronic Pain: Randomized Controlled Trial. J Med Internet Res. 2023 Aug 25;25:e47284. doi: 10.2196/47284.
- Derived from this study: PubMed 35488295Bostrom K, Varsi C, Eide H, Borosund E, Kristjansdottir OB, Schreurs KMG, Waxenberg LB, Weiss KE, Morrison EJ, Nordang EF, Stubhaug A, Nes LS. Engaging with EPIO, a digital pain self-management program: a qualitative study. BMC Health Serv Res. 2022 Apr 29;22(1):577. doi: 10.1186/s12913-022-07963-x.
- Derived from this study: PubMed 35293866Eiken AG, Nordanger DO, Solberg Nes L, Varsi C. Patients' Experiences of Using an eHealth Pain Management Intervention Combined With Psychomotor Physiotherapy: Qualitative Study. JMIR Form Res. 2022 Mar 16;6(3):e34458. doi: 10.2196/34458.
- Derived from this study: PubMed 33766028Varsi C, Ledel Solem IK, Eide H, Borosund E, Kristjansdottir OB, Heldal K, Waxenberg LB, Weiss KE, Schreurs KMG, Morrison EJ, Stubhaug A, Solberg Nes L. Health care providers' experiences of pain management and attitudes towards digitally supported self-management interventions for chronic pain: a qualitative study. BMC Health Serv Res. 2021 Mar 25;21(1):275. doi: 10.1186/s12913-021-06278-7.
- Derived from this study: PubMed 33094734Bostrom K, Borosund E, Varsi C, Eide H, Flakk Nordang E, Schreurs KM, Waxenberg LB, Weiss KE, Morrison EJ, Cvancarova Smastuen M, Stubhaug A, Solberg Nes L. Digital Self-Management in Support of Patients Living With Chronic Pain: Feasibility Pilot Study. JMIR Form Res. 2020 Oct 23;4(10):e23893. doi: 10.2196/23893.
- Derived from this study: PubMed 31961331Ledel Solem IK, Varsi C, Eide H, Kristjansdottir OB, Borosund E, Schreurs KMG, Waxenberg LB, Weiss KE, Morrison EJ, Haaland-Overby M, Bevan K, Zangi HA, Stubhaug A, Solberg Nes L. A User-Centered Approach to an Evidence-Based Electronic Health Pain Management Intervention for People With Chronic Pain: Design and Development of EPIO. J Med Internet Res. 2020 Jan 21;22(1):e15889. doi: 10.2196/15889.
- Derived from this study: PubMed 30877780Ledel Solem IK, Varsi C, Eide H, Kristjansdottir OB, Mirkovic J, Borosund E, Haaland-Overby M, Heldal K, Schreurs KM, Waxenberg LB, Weiss KE, Morrison EJ, Solberg Nes L. Patients' Needs and Requirements for eHealth Pain Management Interventions: Qualitative Study. J Med Internet Res. 2019 Apr 1;21(4):e13205. doi: 10.2196/13205.
- Study web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise Solberg Nes, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPIO in people with Chronic Pain, Widespread, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) (Short Form) - Assessing change (time frame: Baseline, and at 3, 6, and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03705104, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.