Low Back PainMY-RELIEFNCT04673773
MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain.
A study testing A Massive Open Online Course in people with Low Back Pain, run by Lund University at 1 site in Sweden.
Trial summary
Low back pain is the main cause of activity limitation and work absence across the world, leading to a high social and economic burden for individuals, families, the labour market and society. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- A Massive Open Online Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 27 Sep 2021to 31 Jan 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Understand Lithuanian (Lithuanian study), English (N Irish study), Italian (Italian study), Swedish (Sweden) and Portuguese (Portugal).
- Participant is willing and able to give informed consent for participation in the study via the study website.
- Persistent low back pain; defined as pain between scapulae and gluteal region, with or without radiation towards one or both legs, present for at least three months.
- Aged over 55 years
- In employment.
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- People with unexplained symptoms
- People who have not seen a health care professional and received a diagnosis of persistent low back pain
- People who have been given a diagnosis of specific low back pain
- People with evidence of serious underlying pathology, such as a current diagnosis of cancer
- Anyone who has not used or have no interest in using a computer, laptop, tablet or mobile phone.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Lund University
Lund, SE 221 00
Eva E Ekvall Hansson, Professor, +46462221986, eva.ekvall-hansson@med.lu.se
Caroline Larsson, PhD, +46462220000, caroline.larsson@med.lu.se
About this study
Official title: MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain: Using a Digital Platform
Low back pain is the main cause of activity limitation and work absence across the world, leading to a high social and economic burden for individuals, families, the labour market and society. This is particularly true for older adults of working age, employed in sedentary or arduous/strenuous jobs, whose work conditions may influence negatively this health problem and lead to severe persistent low back pain. Pain management is one of the most neglected aspects of healthcare and people suffering from persistent low back pain are often left without specific information, guidance and care from healthcare systems.
The MY-RELEF study is a multinational, multicenter, prospective uncontrolled, pre-post intervention feasibility study targeting people over the age of 55 years with persistent low back pain in Northern Lithuania, Ireland, Italy, Sweden and Portugal. Eligible participants will be offered the opportunity to use the MY RELIEF educational platform as part of their care and will undergo evaluations at baseline (enrollment) and at two-weeks and one-month follow-ups.
Read the detailed description
A Massive Open Online Course (MOOC) called MY RELIEF, have been developed. MY-RELIEF is built on best practices in e-learning, e-health and multimedia-based learning. The training package will be available on mobile devices such as a mobile phone or a tablet. The training is designed in short modules (10-12 minutes per module), possible to complete during a break in work. The MOOC will include short videos with older workers (aged 55+ years) with low back pain and professional experts, as well as knowledge tests and short factual texts. In addition, the target audience will have access to a serious game on their mobile phone that will track their health, and provide feedback on their potentially changing health status, and their engagement with the MOOC units.
The aim for this study is to determinate usability, acceptability and feasibility of a digital education program (MY-RELIEF) delivered via a MOOC for people aged 55+ years with persistent low back pain who are in sedentary or physically demanding jobs, and need advice on ergonomics, self-management of pain and healthy behavioral strategies.
The usability of the intervention will be measured with an industry standard tool to understand peoples ease of interaction with the MOOC and acceptability of the content and format of the MOOC will be measured via qualitative feedback from users.
Feasibility will be informed by the data on likely recruitment and follow up rates in each country for a main trial, floor and ceiling effects and completion rates on outcome measures, and likely within group effect sizes in response to the MOOC.
MY-RELIEF will help to improve and expand the range of high quality learning opportunities tailored to the needs of people over the age of 55 years.
- Conditions
- Low Back Pain
- Being tested
- A Massive Open Online Course
- Keywords
- Low back pain, Older adults, Work
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Massive Open Online CourseBehavioural
Same as intervention
| Study group | Role | What they receive |
|---|---|---|
| Feasibility / A massive open course | Experimental | 1. The online MOOC contains eight units which cover the following topics (Understanding low back pain (LBP), Physical activity and exercise in relation to LBP, Psychological factors, Sleep / nutrition, Management of LBP at the workplace, Communication with health care, Other issues related to LBP). Each unit will include short factual texts, short videos (2-5mins) with older workers (aged 55+ years) with low back pain and professional experts, as well as knowledge tests. The complete MOOC will take 2-3 hours to complete. It would be possible to complete the MOOC at one time however users will be recommended to complete two units per week over a month period.
2. The mobile game is designed to encourage participation with the MOOC by providing feedback on engagement with the MOOC, presentation of quizzes to test knowledge gained on the MOOC, as well as feedback on clinical markers of their condition e.g. Mood, pain, physical activity levels. Receives: Behavioral: A Massive Open Online Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rates
Of the people who are recruited into the study how many MOOC units do they complete
Measured: 4 weeks after baseline
Recruitment of participants
Percentage of people who participate in the intervention by signing up directly to the website versus the percentage who are recruited via the research team
Measured: 4 weeks after baseline
User satisfaction with the MOOC
Qualitative Semi-structured interviews/focus groups
Measured: 4 weeks after baseline
Usability of the MOOC
System usability Scale(SUS), is a simple, ten-item scale giving a global view of subjective assessments of usability. The selected statements in the SUS are measured on a five point Likert scale and cover a variety of aspects of system usability, such as the need for support, training, and complexity, and thus have a high level of validity for measuring usability of a system. The scale yield a score between 0-100 were high values represent high usability.
Measured: 4 weeks after baseline
Change in Participant's health-related quality of life
EQ-5D
Measured: At baseline and 4 weeks later
Change in Functional disability
Functional disability will be measured by the Oswestry Disability Questionnaire. The ODQ consists of 10 sections, each with six levels (with a maximum score in each section of five points) that assess an individual's limitations in various activities of daily living. The sum of all 10 sections is divided by the total possible score and the result multiplied by 100 to generate a percentage score. Values range from 0 (best health state) to 100 (worst health state).
Measured: At baseline and 4 weeks later
Patient ability to cope with with illness and life after using the MOOC
An adapted version of the Patient enablement Instrument (PEI), a six-item questionnaire designed to measure the patient's ability to understand and cope with illness and life following a consultation with a general practitioner will be used. Given this an adapted version of the PEI will be used, where the words 'after this appointment' and 'as a result of your visit to the doctor today' will be replaced by 'after using the Serious game (MOOC)' and 'as a result of using the Serious game(MOOC)
Measured: 4 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start27 Sep 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulster, Kaunas University of Technology, Istituto Nazionale di Ricovero e Cura per Anziani
- Responsible party
- Principal investigator, Eva Ekvall-Hansson, Lund University
- Investigators
- Eva Ekvall-Hansson, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673773
- Sponsor's protocol ID
- 018-1-SE01-KA204-039144
- Acronym
- MY-RELIEF
- Status last verified
- Apr 2022
- First submitted
- 4 Nov 2020
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marley J, Larsson C, Piccinini F, Howes S, Casoni E, Hansson EE, McDonough S. Study protocol for a feasibility study of an online educational programme for people working and living with persistent low back pain. Pilot Feasibility Stud. 2023 Sep 4;9(1):154. doi: 10.1186/s40814-023-01382-3.
PubMed 37667407
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain: Using a Digital Platform
- ClinicalTrials.gov ID
- NCT04673773
- Acronym / sponsor ID
- MY-RELIEF / 018-1-SE01-KA204-039144
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Older adults, Work
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- University of Ulster, Kaunas University of Technology, Istituto Nazionale di Ricovero e Cura per Anziani
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 17 Dec 2020 (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.
Low back pain is the main cause of activity limitation and work absence across the world, leading to a high social and economic burden for individuals, families, the labour market and society. This is particularly true for older adults of working age, employed in sedentary or arduous/strenuous jobs, whose work conditions may influence negatively this health problem and lead to severe persistent low back pain. Pain management is one of the most neglected aspects of healthcare and people suffering from persistent low back pain are often left without specific information, guidance and care from healthcare systems.
The MY-RELEF study is a multinational, multicenter, prospective uncontrolled, pre-post intervention feasibility study targeting people over the age of 55 years with persistent low back pain in Northern Lithuania, Ireland, Italy, Sweden and Portugal. Eligible participants will be offered the opportunity to use the MY RELIEF educational platform as part of their care and will undergo evaluations at baseline (enrollment) and at two-weeks and one-month follow-ups.
Detailed description
A Massive Open Online Course (MOOC) called MY RELIEF, have been developed. MY-RELIEF is built on best practices in e-learning, e-health and multimedia-based learning. The training package will be available on mobile devices such as a mobile phone or a tablet. The training is designed in short modules (10-12 minutes per module), possible to complete during a break in work. The MOOC will include short videos with older workers (aged 55+ years) with low back pain and professional experts, as well as knowledge tests and short factual texts. In addition, the target audience will have access to a serious game on their mobile phone that will track their health, and provide feedback on their potentially changing health status, and their engagement with the MOOC units.
The aim for this study is to determinate usability, acceptability and feasibility of a digital education program (MY-RELIEF) delivered via a MOOC for people aged 55+ years with persistent low back pain who are in sedentary or physically demanding jobs, and need advice on ergonomics, self-management of pain and healthy behavioral strategies.
The usability of the intervention will be measured with an industry standard tool to understand peoples ease of interaction with the MOOC and acceptability of the content and format of the MOOC will be measured via qualitative feedback from users.
Feasibility will be informed by the data on likely recruitment and follow up rates in each country for a main trial, floor and ceiling effects and completion rates on outcome measures, and likely within group effect sizes in response to the MOOC.
MY-RELIEF will help to improve and expand the range of high quality learning opportunities tailored to the needs of people over the age of 55 years.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility / A massive open course | Experimental | Behavioral: A Massive Open Online Course1. The online MOOC contains eight units which cover the following topics (Understanding low back pain (LBP), Physical activity and exercise in relation to LBP, Psychological factors, Sleep / nutrition, Management of LBP at the workplace, Communication with health care, Other issues related to LBP). Each unit will include short factual texts, short videos (2-5mins) with older workers (aged 55+ years) with low back pain and professional experts, as well as knowledge tests. The complete MOOC will take 2-3 hours to complete. It would be possible to complete the MOOC at one time however users will be recommended to complete two units per week over a month period. 2. The mobile game is designed to encourage participation with the MOOC by providing feedback on engagement with the MOOC, presentation of quizzes to test knowledge gained on the MOOC, as well as feedback on clinical markers of their condition e.g. Mood, pain, physical activity levels. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Understand Lithuanian (Lithuanian study), English (N Irish study), Italian (Italian study), Swedish (Sweden) and Portuguese (Portugal).
- Participant is willing and able to give informed consent for participation in the study via the study website.
- Persistent low back pain; defined as pain between scapulae and gluteal region, with or without radiation towards one or both legs, present for at least three months.
- Aged over 55 years
- In employment.
Key exclusion criteria (6 listed)
- People with unexplained symptoms
- People who have not seen a health care professional and received a diagnosis of persistent low back pain
- People who have been given a diagnosis of specific low back pain
- People with evidence of serious underlying pathology, such as a current diagnosis of cancer
- Anyone who has not used or have no interest in using a computer, laptop, tablet or mobile phone.
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 |
|---|---|---|
| A Massive Open Online CourseSame as intervention | Behavioural | Feasibility / A massive open course |
Primary outcome
Retention rates
Time frame: 4 weeks after baseline
Of the people who are recruited into the study how many MOOC units do they complete
Recruitment of participants
Time frame: 4 weeks after baseline
Percentage of people who participate in the intervention by signing up directly to the website versus the percentage who are recruited via the research team
User satisfaction with the MOOC
Time frame: 4 weeks after baseline
Qualitative Semi-structured interviews/focus groups
Usability of the MOOC
Time frame: 4 weeks after baseline
System usability Scale(SUS), is a simple, ten-item scale giving a global view of subjective assessments of usability. The selected statements in the SUS are measured on a five point Likert scale and cover a variety of aspects of system usability, such as the need for support, training, and complexity, and thus have a high level of validity for measuring usability of a system. The scale yield a score between 0-100 were high values represent high usability.
Change in Participant's health-related quality of life
Time frame: At baseline and 4 weeks later
EQ-5D
Change in Functional disability
Time frame: At baseline and 4 weeks later
Functional disability will be measured by the Oswestry Disability Questionnaire. The ODQ consists of 10 sections, each with six levels (with a maximum score in each section of five points) that assess an individual's limitations in various activities of daily living. The sum of all 10 sections is divided by the total possible score and the result multiplied by 100 to generate a percentage score. Values range from 0 (best health state) to 100 (worst health state).
Patient ability to cope with with illness and life after using the MOOC
Time frame: 4 weeks after baseline
An adapted version of the Patient enablement Instrument (PEI), a six-item questionnaire designed to measure the patient's ability to understand and cope with illness and life following a consultation with a general practitioner will be used. Given this an adapted version of the PEI will be used, where the words 'after this appointment' and 'as a result of your visit to the doctor today' will be replaced by 'after using the Serious game (MOOC)' and 'as a result of using the Serious game(MOOC)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Derived from this study: PubMed 37667407Marley J, Larsson C, Piccinini F, Howes S, Casoni E, Hansson EE, McDonough S. Study protocol for a feasibility study of an online educational programme for people working and living with persistent low back pain. Pilot Feasibility Stud. 2023 Sep 4;9(1):154. doi: 10.1186/s40814-023-01382-3.
- 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.
Eva Ekvall-Hansson, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Massive Open Online Course in people with Low Back Pain, run by Lund University 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Ekvall-Hansson, PhD (+46 46 222 19 86, eva.ekvall-hansson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rates (time frame: 4 weeks after baseline). The study lists 7 primary outcomes in all. 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 NCT04673773, which also lists 1 linked publication.
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 12 Apr 2022.