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Workplace Exercise and Pain Education Intervention in Office Workers

Primary Purpose

Back Pain, Sedentary Behavior

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapeutic Exercise Intervention
Pain education
Sponsored by
Universitat de Lleida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring Back Pain, Health Education, Therapeutic Exercise, Sedentary Behavior

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • More than 80% of the working day is in a seated position.
  • Workers who have a computer or mobile device with an internet connection.
  • Workers with more than three months of pain in the back area due to a non-specific cause.

Exclusion Criteria:-

  • Part-time workers.
  • Pathologies that cause chronic pain.
  • Radiculopathies or symptomatic disc herniations/protrusions.
  • Inability to perform low-moderate intensity exercise.
  • People who are active in their daily lives outside of work willing to report that they meet the minimum stipulated by the WHO (a minimum of 10,000 steps per day and 75-150 minutes of vigorous-moderate physical activity per week).
  • Undergoing physiotherapy treatment through public health or a private company.
  • Workers on sick leave or during pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Therapeutic exercise and pain education

    Therapeutic exercise only

    Arm Description

    It consists of implementing active breaks at the workstation through a web application, in which they will perform strength and mobility exercise sessions through general low-moderate intensity movements. In this arm, daily short-form content also is given on pain and the relationship of musculoskeletal pathologies with sedentary lifestyles and maintained postures. The type of online application will depend on the results obtained in the qualitative phase, as we will adapt to the workers' preferences to facilitate accessibility to the content and make the experience as satisfactory as possible for them.

    Workers in this arm Will receive the same procedure as Group 1 without the short-form content of pain education. Once the intervention is finished, this content will be added in an infographic or audio-visual format pain education information, giving the same access to the participants.

    Outcomes

    Primary Outcome Measures

    Reduction of Back Pain
    The primary outcome to be analysed is back pain using the Visual Analogue Scale, a subjective assessment scale of intensity from 0 to 10, with 0 being "no pain" and 10 being "the worst possible pain".

    Secondary Outcome Measures

    Back pain dysfunction
    Will be analysed using the Spanish version of the Spine Functional Index, a self-administered questionnaire in which the patient reports the state of his or her back concerning disability and dysfunction in daily activities.
    Health related quality of life
    Will be analysed using the Spanish version of the EQ-5D-5L quality of life questionnaire which consists of 5 dimensions: mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression.
    Motivation of performing therapeutic exercise
    Motivation when performing the therapeutic exercise intervention will be analysed using the Spanish version of the questionnaire: Behavioural Regulation in Exercise Questionnaire-2.
    Adherence to therapeutic exercise
    The percentage of open sessions and total video played of the participant will be analysed by the web analytics.

    Full Information

    First Posted
    September 30, 2022
    Last Updated
    October 4, 2022
    Sponsor
    Universitat de Lleida
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05571124
    Brief Title
    Workplace Exercise and Pain Education Intervention in Office Workers
    Official Title
    The Implementation of a Web-based Workplace Exercise and Pain Education Intervention in the Reduction of Back Pain in Sedentary Administrative Personnel: Protocol of a Mixed Methodology Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    May 30, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitat de Lleida

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The goal of this Clinical trial is to compare treatments in sedentary administrative personnel with back pain. The main question it aims to answer: The benefits of a workplace intervention with therapeutic exercise and pain education compared with only therapeutic exercise intervention Participants will perform active pauses in their workplace with a web-based program that consists of videos or images of exercises and pain education information. Researchers will compare a group Therapeutic exercise and pain education intervention with a group therapeutic exercise only to see if pain education plus exercise is a more beneficial intervention in reducing back pain in symptomatic administrative personnel.
    Detailed Description
    Introduction: Musculoskeletal pathologies are one of the leading causes of disability for the population worldwide, with office workers being one of the most affected groups. This study aims to design and implement a programme of therapeutic exercise and pain education in the workplace to reduce musculoskeletal pathology. The use of therapeutic exercise interventions at work is an economical and feasible option in which it is essential to consider biopsychosocial aspects when designing a successful treatment. Methods: Mixed methodology study. Phase 1: A qualitative study with a phenomenological approach using semi-structured interviews to determine factors related to office workers' expectations about pain, maintaining static postures at work and implementing active breaks. Phase 2: Implementation of a Randomised Controlled Trial considering current scientific evidence and the results of the first phase with two intervention groups. A group in which therapeutic exercise will be performed at work with pain education, compared to a group implementing only exercise at the workplace. Discussion: This study is a comprehensive and pragmatic intervention to implement therapeutic exercise in the workplace, considering workers' expectations regarding their pain and the implementation of active breaks. The use of digitalisation in the implementation of therapeutic exercise and pain education in office workers is a feasible and low-cost option. It can improve office workers' quality of life by increasing motivation and adherence to such interventions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Back Pain, Sedentary Behavior
    Keywords
    Back Pain, Health Education, Therapeutic Exercise, Sedentary Behavior

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    To ensure that allocation is concealed, one of the researchers will randomly create the codes in opaque envelopes with the username and password for participants to log into the web platform. The evaluators will be blinded to the data collection as each participant will be assigned a code for identification. The participants will not be blinded as they are aware of the intervention they are carrying out.
    Allocation
    Randomized
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Therapeutic exercise and pain education
    Arm Type
    Experimental
    Arm Description
    It consists of implementing active breaks at the workstation through a web application, in which they will perform strength and mobility exercise sessions through general low-moderate intensity movements. In this arm, daily short-form content also is given on pain and the relationship of musculoskeletal pathologies with sedentary lifestyles and maintained postures. The type of online application will depend on the results obtained in the qualitative phase, as we will adapt to the workers' preferences to facilitate accessibility to the content and make the experience as satisfactory as possible for them.
    Arm Title
    Therapeutic exercise only
    Arm Type
    Active Comparator
    Arm Description
    Workers in this arm Will receive the same procedure as Group 1 without the short-form content of pain education. Once the intervention is finished, this content will be added in an infographic or audio-visual format pain education information, giving the same access to the participants.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Therapeutic Exercise Intervention
    Other Intervention Name(s)
    Workplace exercise intervention, Active pause
    Intervention Description
    Participants will perform stretching, mobility and strength training exercises in short bouts of time.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pain education
    Other Intervention Name(s)
    Health education
    Intervention Description
    Images and short videos with information of pain education content related to sedentary behaviour, pain and posture.
    Primary Outcome Measure Information:
    Title
    Reduction of Back Pain
    Description
    The primary outcome to be analysed is back pain using the Visual Analogue Scale, a subjective assessment scale of intensity from 0 to 10, with 0 being "no pain" and 10 being "the worst possible pain".
    Time Frame
    Change from baseline back pain at six weeks
    Secondary Outcome Measure Information:
    Title
    Back pain dysfunction
    Description
    Will be analysed using the Spanish version of the Spine Functional Index, a self-administered questionnaire in which the patient reports the state of his or her back concerning disability and dysfunction in daily activities.
    Time Frame
    Change from baseline back pain dysfunction at six weeks
    Title
    Health related quality of life
    Description
    Will be analysed using the Spanish version of the EQ-5D-5L quality of life questionnaire which consists of 5 dimensions: mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression.
    Time Frame
    Change from baseline quality of life at six weeks
    Title
    Motivation of performing therapeutic exercise
    Description
    Motivation when performing the therapeutic exercise intervention will be analysed using the Spanish version of the questionnaire: Behavioural Regulation in Exercise Questionnaire-2.
    Time Frame
    Change from baseline motivation of performing therapeutic exercise at six weeks
    Title
    Adherence to therapeutic exercise
    Description
    The percentage of open sessions and total video played of the participant will be analysed by the web analytics.
    Time Frame
    Through study completion, an average of six weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: More than 80% of the working day is in a seated position. Workers who have a computer or mobile device with an internet connection. Workers with more than three months of pain in the back area due to a non-specific cause. Exclusion Criteria:- Part-time workers. Pathologies that cause chronic pain. Radiculopathies or symptomatic disc herniations/protrusions. Inability to perform low-moderate intensity exercise. People who are active in their daily lives outside of work willing to report that they meet the minimum stipulated by the WHO (a minimum of 10,000 steps per day and 75-150 minutes of vigorous-moderate physical activity per week). Undergoing physiotherapy treatment through public health or a private company. Workers on sick leave or during pregnancy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carlos Tersa Miralles, PhD student
    Phone
    676201743
    Email
    carles.tersa@udl.cat
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Esther Rubinat Arnaldo, PhD
    Organizational Affiliation
    Universitat de Lleida
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Francesc Rubi Carnacea, PhD
    Organizational Affiliation
    Universitat de Lleida
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Workplace Exercise and Pain Education Intervention in Office Workers

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