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

NCT04673773 | Unknown

• 1 other identifier: 018-1-SE01-KA204-039144
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low back pain; Older adults; Work

Outcome Measures

Primary Outcomes (7)

• Retention rates

  Of the people who are recruited into the study how many MOOC units do they complete

  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

  4 weeks after baseline

• User satisfaction with the MOOC

  Qualitative Semi-structured interviews/focus groups

  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.

  4 weeks after baseline

• Change in Participant's health-related quality of life

  EQ-5D

  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).

  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)

  4 weeks after baseline

Study Arms (1)

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.

Behavioral: A Massive Open Online Course

Interventions

A Massive Open Online Course BEHAVIORAL

Same as intervention

Feasibility / A massive open course

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lund University: lead
• University of Ulster: collaborator
• Kaunas University of Technology: collaborator
• Istituto Nazionale di Ricovero e Cura per Anziani: collaborator

Study Sites (1)

Lund University

Lund, SE 221 00, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 37667407 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eva Ekvall-Hansson, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Ekvall-Hansson, PhD

CONTACT

+46 46 222 19 86; eva.ekvall-hansson@med.lu.se

Caroline Larsson, PhD

CONTACT

+46 46 222 19 86; caroline.larsson@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: December 17, 2020
• Study Start: September 27, 2021
• Primary Completion: December 30, 2022
• Study Completion: January 31, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)