Clinical trial NCT05664776: Effect of Dynamic Sitting on Pain Development
Official title: Effect of Dynamic Sitting on Pain Development in Adult Pain Developers in Sedentary Environments - a Randomized Controlled Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Back Pain
Keywords: Sedentary Behavior
Occupational Diseases
Pain Developer
Lower Back Pain
Office Environments
Lead sponsor: University of Applied Sciences for Health Professions Upper Austria
Sponsor class: OTHER
Collaborators: name: Bergardi GmbH
First posted: 2022-12-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Mean change in subjectively perceived lower back pain as determined with a Visual Analogue Scale (VAS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in impact of pain on daily life (pre- vs. post-intervention) estimated with the German version of the Oswestry Disability Index (ODI-D)
timeFrame: 6 weeks
measure: Mean change in subjectively perceived mental fatigue (pre- vs. post-work, weekly average) estimated via Visual Analogue Scale (VAS)
timeFrame: 6 weeks
measure: Mean subjectively rated working performance (post-work, weekly average) estimated via VAS
timeFrame: 6 weeks
measure: Change in quality of life (pre- vs. post-intervention) estimated via 5-level EuroQol quality of life questionnaire (EQ-5D-5L)
timeFrame: 6 weeks
measure: User's experience estimated with the User Experience Questionnaire-Short version (UEQ-S)
timeFrame: 6 weeks
measure: User's experience via qualitative interview
timeFrame: 6 weeks
measure: Number of adverse events (AE) estimated via an adverse event form sheet
timeFrame: 16 weeks
measure: Sitting behaviors estimated via microcontrollers
timeFrame: During the 6 weeks of the period of intervention
Other outcomes:
Locations:
city: Linz
country: Austria
facility: University of Applied Sciences for Health Professions Upper Austria
state: Upper Austria
Study officials:
affiliation: FH Gesundheitsberufe OÖ
name: Bernhard Schwartz, Dr. BSc MSc
role: PRINCIPAL_INVESTIGATOR
References: