NCT05571124

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

September 30, 2022

Last Update Submit

November 28, 2023

Conditions

Keywords

Back PainHealth EducationTherapeutic ExerciseSedentary Behavior

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Back pain dysfunction

    Change from baseline back pain dysfunction at six weeks

  • Health related quality of life

    Change from baseline quality of life at six weeks

  • Motivation of performing therapeutic exercise

    Change from baseline motivation of performing therapeutic exercise at six weeks

  • Adherence to therapeutic exercise

    Through study completion, an average of six weeks

Study Arms (2)

Therapeutic exercise

EXPERIMENTAL

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

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.

Interventions

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

Also known as: Workplace exercise intervention, Active Breaks
Therapeutic exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat de Lleida

Lleida, Catalonia, 25008, Spain

RECRUITING

Related Publications (43)

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MeSH Terms

Conditions

Back PainSedentary BehaviorHealth Education

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Esther Rubinat Arnaldo, PhD

    Universitat de Lleida

    STUDY DIRECTOR
  • Francesc Rubi Carnacea, PhD

    Universitat de Lleida

    STUDY DIRECTOR

Central Study Contacts

Carlos Tersa Miralles, PhD student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tersa-Miralles C

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 7, 2022

Study Start

October 1, 2023

Primary Completion

May 30, 2024

Study Completion

December 31, 2024

Last Updated

December 5, 2023

Record last verified: 2023-11

Locations