Clinical trial NCT04673773: MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Older adults
Work
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: University of Ulster
name: Kaunas University of Technology
name: Istituto Nazionale di Ricovero e Cura per Anziani
First posted: 2020-12-17
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion criteria:

1. Understand Lithuanian (Lithuanian study), English (N Irish study), Italian (Italian study), Swedish (Sweden) and Portuguese (Portugal).
2. Participant is willing and able to give informed consent for participation in the study via the study website.
3. 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.
4. Aged over 55 years
5. In employment.

Exclusion Criteria

The participant may not enter the study if ANY of the following apply:

1. People with unexplained symptoms
2. People who have not seen a health care professional and received a diagnosis of persistent low back pain
3. People who have been given a diagnosis of specific low back pain
4. People with evidence of serious underlying pathology, such as a current diagnosis of cancer
5. Anyone who has not used or have no interest in using a computer, laptop, tablet or mobile phone.

Primary outcomes:
measure: Retention rates
timeFrame: 4 weeks after baseline
measure: Recruitment of participants
timeFrame: 4 weeks after baseline
measure: User satisfaction with the MOOC
timeFrame: 4 weeks after baseline
measure: Usability of the MOOC
timeFrame: 4 weeks after baseline
measure: Change in Participant's health-related quality of life
timeFrame: At baseline and 4 weeks later
measure: Change in Functional disability
timeFrame: At baseline and 4 weeks later
measure: Patient ability to cope with with illness and life after using the MOOC
timeFrame: 4 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University
Study officials:
affiliation: Lund University
name: Eva Ekvall-Hansson, PhD
role: PRINCIPAL_INVESTIGATOR
References: