Chronic PainNCT04865263
Management of Chronic Pain
An observational study of Chronic Pain, run by Lund University at 1 site in United States.
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?
- Digital Pain-Management Tool
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Aug 2022
- Phase
- Observational
- 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
Study population: Adults with chronic pain patients at the Newton-Wellesley Hospital, 159 Wells Ave., Newton, MA - A specialist clinic for pain therapy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Newton-Wellesley Hospital- Ambulatory Pain Service
Newton, Massachusetts, 02459
About this study
Official title: Digital Self-Management of Chronic Pain
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 (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:
- 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
- Conditions
- Chronic Pain
- Being tested
- Digital Pain-Management Tool
- 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.
Digital Pain-Management ToolDevice
Self management digital tool for chronic pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain interference
Change from baseline in pain interference (QoL), measured by PROMIS Pain Interference 6a . Measure of the amount of interference pain causes in life; range 6-30; higher is worse
Measured: 6 and 12 weeks from baseline
Secondary outcomes (6)
Pain severity
Change from Baseline in the 7 day average pain intensity. Measured by NRS using an 11-point Pain Intensity Numerical Rating Scale (NRS) (0=no pain, 10=pain as bad as you can imagine)
Measured: 6 and 12 weeks from baseline
Physical function
Change from baseline in physical function, measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Physical function 10a.
Measure of the impact of a condition on physical function; range 4-20; higher is worse
Measured: 6 and 12 weeks from baseline
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 lower scores representing less endorsement of depression
Measured: 6 and 12 weeks from baseline
Anxiety
Change from Baseline measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety 4.
Measures the extent to which patients experience anxiety symptoms over the past 7 days. Raw scores range from 4-20 with lower scores representing less endorsement of anxiety.
Measured: 6 and 12 weeks from baseline
Pain Catastrophizing
The Pain Catastrophizing Scale (PCS) is a 13-item self-administered scale and one of the most widely used to assess pain catastrophizing The theoretical range of the instrument is between 0 and 52, with low scores indicating low catastrophizing, and high values showing high catastrophizing.
Measured: 6 and 12 weeks from baseline
Chronic Pain Acceptance
Chronic Pain Acceptance Questionnaire-8 (CPAQ-8) CPAQ-8 is an 8-question survey that measures the level of patient acceptance of pain. The scale ranges from 0-48 and where a higher scores corresponds to greater acceptance of pain.
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.
- First posted29 Apr 2021
- Study start1 Jul 2021
- Primary completion1 May 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Newton-Wellesley Hospital
- Responsible party
- Sponsor
- Investigators
- Antje Barreveld,, MD, Principal investigator, Newton-Wellesley Hospital Pain Research Team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865263
- Sponsor's protocol ID
- US3
- Status last verified
- Feb 2023
- First submitted
- 26 Apr 2021
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Self-Management of Chronic Pain
- ClinicalTrials.gov ID
- NCT04865263
- Acronym / sponsor ID
- US3
- Conditions
- Chronic Pain
- Keywords
- self management, e-health, health tech, Digital Pain-Management Tool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Newton-Wellesley Hospital
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 29 Apr 2021 (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 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:
- 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with chronic pain patients at the Newton-Wellesley Hospital, 159 Wells Ave., Newton, MA - A specialist clinic for pain therapy.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Digital Pain-Management ToolSelf management digital tool for chronic pain | Device | – |
Primary outcome
Pain interference
Time frame: 6 and 12 weeks from baseline
Change from baseline in pain interference (QoL), measured by PROMIS Pain Interference 6a . Measure of the amount of interference pain causes in life; range 6-30; higher is worse
6 secondary outcomes
Pain severity
Time frame: 6 and 12 weeks from baseline
Physical function
Time frame: 6 and 12 weeks from baseline
Depression
Time frame: 6 and 12 weeks from baseline
Anxiety
Time frame: 6 and 12 weeks from baseline
Pain Catastrophizing
Time frame: 6 and 12 weeks from baseline
Chronic Pain Acceptance
Time frame: 6 and 12 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
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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.
Antje Barreveld,, MD principal investigator
Newton-Wellesley Hospital Pain Research Team
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Lund University at 1 site in United States.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 13 Feb 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 13 Feb 2023.