Effect of Dynamic Sitting on Pain Development

NCT ID: NCT05664776

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2023-10-20

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.

Detailed Description

This clinical investigation is a prospective, randomized, controlled, counter-balanced, two-arm field study investigating the effect of dynamic sitting on musculoskeletal pain in office workers classified as pain developers.

The study consists of a pre-screening visit and 4 assessment days / visits. During this pre-screening visit and after proving the study eligibility (inclusion / exclusion criteria), half of the study participants will randomly be allocated to one of the two study arms. Depending on the arm allocation, participants will receive a dynamic (= intervention) or static (= control) office chair for 6 weeks. After a wash-out of at least 4 weeks the 6-week intervention resp. control will be switched. The randomization will be realized with opaque envelopes.

Overall participants will execute the identical assessments within the control and the intervention chair group. The wash-out phase between the control and the intervention periods will ensue identical baseline conditions for both chairs. The overall duration of study participation amounts to 16 weeks.

Conditions

Lower Back Pain

Keywords

Sedentary Behavior; Occupational Diseases; Pain Developer; Lower Back Pain; Office Environments

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm A (control first)

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.

Group Type: EXPERIMENTAL

Dynamic office chair

Intervention Type: DEVICE

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 B (intervention first)

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.

Group Type: EXPERIMENTAL

Dynamic office chair

Intervention Type: DEVICE

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.

Interventions

Dynamic office chair

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bergardi GmbH

UNKNOWN

Sponsor Role: collaborator

University of Applied Sciences for Health Professions Upper Austria

OTHER

Sponsor Role: lead

Responsible Party

Bernhard Schwartz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernhard Schwartz, Dr. BSc MSc

Role: PRINCIPAL_INVESTIGATOR

FH Gesundheitsberufe OÖ

Locations

University of Applied Sciences for Health Professions Upper Austria

Linz, Upper Austria, Austria

Countries

Austria

Other Identifiers

DynSit-Pain

Identifier Type: -

Identifier Source: org_study_id