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Chronic PainNCT05213468

Self-management of Chronic Pain Though E-health

A study testing PainDrainerTM in people with Chronic Pain, run by PainDrainer AB at 1 site in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain
What is being tested?
PainDrainerTM
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteSweden
Study dates
1 Feb 2022to 1 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

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

  • 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

Who cannot join

  • Severe or acute psychiatric illness, severe anxiety or depression

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • VO Neurokirurgi och Smärtrehabilitering Skånes universitetssjukhus

    Lund, 21428

Other trials in Sweden

About this study

Official title: Self-management of Chronic Pain Through the Use of the Digital Tool PainDrianer

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.

Read the 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
Conditions
Chronic Pain
Being tested
PainDrainerTM
Keywords
self management, e-health, health tech, Digital Pain-Management Tool
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PainDrainerTMDevice

    Self management digital tool for chronic pain

Study groups in NCT05213468
Study groupRoleWhat they receive
Self management app as add on to standard careExperimentalPainDrainerTM 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.
Receives: Device: PainDrainerTM
Standard of careNo interventionTreatment as usual, standard treatment of care at the physiotherapy program at the clinic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 and 12 weeks from baseline

Secondary outcomes (7)

  1. 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)

    Measured: 6 and 12 weeks from baseline

  2. 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.

    Measured: 6 and 12 weeks from baseline

  3. 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.

    Measured: 6 and 12 weeks from baseline

  4. 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.

    Measured: 6 and 12 weeks from baseline

  5. 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.

    Measured: 6 and 12 weeks from baseline

  6. 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.

    Measured: 6 and 12 weeks from baseline

  7. 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.

    Measured: 6 and 12 weeks from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2022
  2. Study start1 Feb 2022
  3. Primary completion1 Apr 2023
  4. Study completion1 Apr 2023

Why it 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.

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel study, single blinded
Masking
Single blind
Who is masked
Care provider
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05213468
Sponsor's protocol ID
SUS-S1
Status last verified
Jun 2023
First submitted
5 Jan 2022
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PainDrainerTM in people with Chronic Pain, run by PainDrainer AB at 1 site in Sweden.

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 6 inclusion and 1 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: stopped early, as of the sponsor's last update on 15 Jun 2023. 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 Sweden. 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?

The study was stopped early (reason given: 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.). Results are not available in the source record.

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?

Pain interference (time frame: 6 and 12 weeks from baseline). 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 NCT05213468.

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 15 Jun 2023.

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