MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain.

Low Back Pain Clinical Trial

— MY-RELIEF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04673773
• Other study ID #: 018-1-SE01-KA204-039144
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2022
• Source: Lund University
• Contact: Eva Ekvall-Hansson, PhD
• Phone: +46 46 222 19 86
• Email: eva.ekvall-hansson[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• A Massive Open Online Course
Same as intervention

Locations

Country	Name	City	State
Sweden	Lund University	Lund

Sponsors (4)

Lead Sponsor	Collaborator
Lund University	Istituto Nazionale di Ricovero e Cura per Anziani, Kaunas University of Technology, University of Ulster

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rates	Of the people who are recruited into the study how many MOOC units do they complete	4 weeks after baseline
Primary	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	4 weeks after baseline
Primary	User satisfaction with the MOOC	Qualitative Semi-structured interviews/focus groups	4 weeks after baseline
Primary	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.	4 weeks after baseline
Primary	Change in Participant's health-related quality of life	EQ-5D	At baseline and 4 weeks later
Primary	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).	At baseline and 4 weeks later
Primary	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)	4 weeks after baseline