NCT05664776

Brief Summary

Worksite based prolonged static sitting postures can cause musculoskeletal pain. While the development of pain increases due to the constant growth of digitalization at work, numerous interventions to reduce prolonged sitting periods have been created. The effects of such interventions have not yet been properly examined. Thus, the "DynSit-Pain" project was initiated to investigate the influence of dynamic sitting on the pain development of pain developers in office environments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 5, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

December 5, 2022

Last Update Submit

December 4, 2023

Conditions

Keywords

Sedentary BehaviorOccupational DiseasesPain DeveloperLower Back PainOffice Environments

Outcome Measures

Primary Outcomes (1)

  • Mean change in subjectively perceived lower back pain as determined with a Visual Analogue Scale (VAS)

    Participants will rate their subjectively perceived lower back pain before and after a conventional occupational day on 5 consecutive days starting at baseline (week 1) and ending with the post-intervention visit (week 6). Subjectively perceived lower back pain will be assessed with a Visual Analogue Scale (VAS). The VAS used for this study ranges from 0 (none) to 100 points (strongest pain imaginable). Question: Please rate the level of your lower back pain at this moment.

    6 weeks

Secondary Outcomes (8)

  • Change in impact of pain on daily life (pre- vs. post-intervention) estimated with the German version of the Oswestry Disability Index (ODI-D)

    6 weeks

  • Mean change in subjectively perceived mental fatigue (pre- vs. post-work, weekly average) estimated via Visual Analogue Scale (VAS)

    6 weeks

  • Mean subjectively rated working performance (post-work, weekly average) estimated via VAS

    6 weeks

  • Change in quality of life (pre- vs. post-intervention) estimated via 5-level EuroQol quality of life questionnaire (EQ-5D-5L)

    6 weeks

  • User's experience estimated with the User Experience Questionnaire-Short version (UEQ-S)

    6 weeks

  • +3 more secondary outcomes

Study Arms (2)

Arm A (control first)

EXPERIMENTAL

The pre-existing static office chair will be used in the personal workplace for the first 6 weeks within the first half of the study. A wash-out period of a minimum of 4 weeks will be executed after the first half of the study. A dynamic office chair will be used on the personal workstation for 6 weeks within the second half of the study after the wash-out period.

Device: Dynamic office chair

Arm B (intervention first)

EXPERIMENTAL

A dynamic office chair will be used in the personal workplace for the first 6 weeks within the first half of the study. A wash-out period of a minimum of 4 weeks will be executed after the first half of the study. The pre-existing static office chair will be used on the personal workstation for 6 weeks within the second half of the study after the wash-out period.

Device: Dynamic office chair

Interventions

The dynamic office chair has a typical office chair design (e.g. seat pan and a lumbar support). The seat pan is mounted on a flexible mechanic construction that allows hip movements in the frontal plane while sitting.

Arm A (control first)Arm B (intervention first)

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent
  • People aged between 18 and 65 years
  • People classified as pain developers (e.g., increase of pain of 10 mm on a 100 mm paper based visual analogue scale) determined by pre-screening
  • Office workers
  • Employment status: \> 30 h / week
  • Sufficient German language skills (minimum B2 level)
  • Table height of at least 63 cm at the main workplace

You may not qualify if:

  • Physical or mental limitations that aggravate dynamic sitting or using the interventional chair (e.g., wheel chair users, vestibular dysfunctions)
  • Pregnancy
  • Working in sitting posture for less than 20 hours per working week in the main workplace.
  • Bodyweight over 110 kg and a body height over 195 cm
  • Regular therapy or medication for pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Applied Sciences for Health Professions Upper Austria

Linz, Upper Austria, 4020, Austria

Location

MeSH Terms

Conditions

Low Back PainSedentary BehaviorOccupational Diseases

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Bernhard Schwartz, Dr. BSc MSc

    FH Gesundheitsberufe OÖ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 27, 2022

Study Start

December 5, 2022

Primary Completion

October 20, 2023

Study Completion

October 20, 2023

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations