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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05571124
Other study ID # WEI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date December 31, 2024

Study information

Verified date November 2023
Source Universitat de Lleida
Contact Carlos Tersa Miralles, PhD student
Phone 676201743
Email carles.tersa@udl.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date December 31, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Therapeutic Exercise Intervention
Participants will perform stretching and mobility exercises in short bouts of time.

Locations

Country Name City State
Spain Universitat de Lleida Lleida Catalunya

Sponsors (1)

Lead Sponsor Collaborator
Universitat de Lleida

Country where clinical trial is conducted

Spain, 

References & Publications (42)

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Janwantanakul P, Sihawong R, Sitthipornvorakul E, Paksaichol A. A Path Analysis of the Effects of Biopsychosocial Factors on the Onset of Nonspecific Low Back Pain in Office Workers. J Manipulative Physiol Ther. 2018 Jun;41(5):405-412. doi: 10.1016/j.jmpt.2017.10.012. Epub 2018 Jul 12. — View Citation

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* Note: There are 42 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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". Change from baseline back pain at six weeks
Secondary 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. Change from baseline back pain dysfunction at six weeks
Secondary 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. Change from baseline quality of life at six weeks
Secondary 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. Change from baseline motivation of performing therapeutic exercise at six weeks
Secondary Adherence to therapeutic exercise 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
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