Workplace Exercise and Pain Education Intervention in Office Workers

Sponsor

Universitat de Lleida (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05571124

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Back Pain Sedentary Behavior	Behavioral: Therapeutic Exercise Intervention Behavioral: Pain education	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes 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.

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

May 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Therapeutic exercise and pain education 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.	Behavioral: Therapeutic Exercise Intervention Participants will perform stretching, mobility and strength training exercises in short bouts of time. Other Names: Workplace exercise intervention Active pause Behavioral: Pain education Images and short videos with information of pain education content related to sedentary behaviour, pain and posture. Other Names: Health education
Active Comparator: Therapeutic exercise only 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.	Behavioral: Therapeutic Exercise Intervention Participants will perform stretching, mobility and strength training exercises in short bouts of time. Other Names: Workplace exercise intervention Active pause

Arm

Intervention/Treatment

Experimental: Therapeutic exercise and pain education

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.

Behavioral: Therapeutic Exercise Intervention

Participants will perform stretching, mobility and strength training exercises in short bouts of time.

Other Names:

Workplace exercise intervention

Active pause

Behavioral: Pain education

Images and short videos with information of pain education content related to sedentary behaviour, pain and posture.

Other Names:

Health education

Active Comparator: Therapeutic exercise only

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.

Behavioral: Therapeutic Exercise Intervention

Participants will perform stretching, mobility and strength training exercises in short bouts of time.

Other Names:

Workplace exercise intervention

Active pause

Outcome Measures

Primary Outcome Measures

Reduction of Back Pain [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".

Secondary Outcome Measures

Back pain dysfunction [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.
Health related quality of life [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.
Motivation of performing therapeutic exercise [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.
Adherence to therapeutic exercise [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Universitat de Lleida

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Carlos Tersa Miralles, Tersa-Miralles C, Universitat de Lleida

ClinicalTrials.gov Identifier:

NCT05571124

Other Study ID Numbers:

First Posted:

Oct 7, 2022

Last Update Posted:

Oct 7, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Carlos Tersa Miralles, Tersa-Miralles C, Universitat de Lleida

Additional relevant MeSH terms:

Back Pain

Study Results

No Results Posted as of Oct 7, 2022