Workplace Exercise Intervention in Administrative Personnel to Reduce Spinal Pain

November 28, 2023 updated by: Carlos Tersa Miralles, Universitat de Lleida

The Implementation of a Web-based Workplace Exercise Intervention in the Reduction of Spinal Pain in Sedentary Administrative Personnel: Protocol of a Mixed Methodology Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Catalunya
      • Lleida, Catalunya, Spain, 25008
        • Recruiting
        • Universitat de Lleida
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic exercise
It consists of implementing active breaks at the workstation through the use of the open source Learning Management System Sakai [33], It will be easy to use by the participants due to the platform is used by them in their daily work. Also, an administrative worker from the university will be involved in creating the modules where the content will be allocated to ensure that the navigation in the platform is user-friendly for them.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.
Behavioral: Therapeutic Exercise Intervention
Participants will perform stretching and mobility exercises in short bouts of time.
Other Names:
  • Workplace exercise intervention
  • Active Breaks
No Intervention: No intervention
Participants of the control group will be on a waiting list, encouraging them to maintain the same as usual in their daily activities and working hours. Once the intervention is finished, they will have access to the platform with the same content as the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Back Pain
Time Frame: Change from baseline back pain at six weeks
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".
Change from baseline back pain at six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Back pain dysfunction
Time Frame: Change from baseline back pain dysfunction at six weeks
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.
Change from baseline back pain dysfunction at six weeks
Health related quality of life
Time Frame: Change from baseline quality of life at six weeks
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.
Change from baseline quality of life at six weeks
Motivation of performing therapeutic exercise
Time Frame: Change from baseline motivation of performing therapeutic exercise at six weeks
Motivation when performing the therapeutic exercise intervention will be analysed using the Spanish version of the questionnaire: Behavioural Regulation in Exercise Questionnaire-2.
Change from baseline motivation of performing therapeutic exercise at six weeks
Adherence to therapeutic exercise
Time Frame: Through study completion, an average of six weeks
The percentage of open sessions and total video played of the participant will be analysed by the web analytics.
Through study completion, an average of six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat de Lleida

Investigators

  • Study Director: Esther Rubinat Arnaldo, PhD, Universitat de Lleida
  • Study Director: Francesc Rubi Carnacea, PhD, Universitat de Lleida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 30, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WEI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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