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As a follow-up project to the Dyn-Sit-Pain study, this research aims to investigate the overall health as well as the physical and mental well-being through dynamic office chairs. The development of an innovative dynamic office chair concept will be professionally and scientifically supported, and the developed prototypes will be examined within the framework of usability studies.
This clinical trial is a prospective, randomised, controlled, open-label study with two tracks, each in a cross-over design investigating the effect of of two dynamic office chairs (saddle chair with standard pendulum mechanism [Smart Moving Technology], study track 2 = office swivel chair with integrated newly developed pendulum mechanism [Smart Moving Technology New]) on the musculoskeletal system of office workers classified as pain developers.
The study consists of a pre-screening visit and 4 assessment days / visits. After proving eligibility for the study (inclusion/exclusion criteria), subjects are assigned to one of the two study tracks. Subjects are randomised to one of the two study tracks and then to the respective group (Group A to D).
Depending on the study track and group allocation, the test subjects first receive a dynamic office chair (= intervention) or a static office chair (= control). The randomization will be realized with opaque envelopes in different colours and follows international recommendations.
Overall participants will execute identical assessments. A wash-put period between the control and the intervention phases ensures identical baseline conditions. The overall duration of study participation equals 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Track 1: Group A | 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 (saddle chair with standard pendulum mechanism) will be used on the personal workstation for 6 weeks within the second half of the study after the wash-out period. |
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| Study Track 1: Group B | Experimental | A dynamic office chair (saddle chair with standard pendulum mechanism) 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. |
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| Study Track 2: Group C | 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 (office swivel chair with integrated newly developed pendulum mechanism) will be used on the personal workstation for 6 weeks within the second half of the study after the wash-out period. |
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| Study Track 2: Group D |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic office chair (saddle chair with standard pendulum mechanism) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in subjective lower back pain (before vs. after work, weekly average) estimated by 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in subjective mental fatigue (before vs. after work, weekly average) estimated by VAS | Participants will rate their subjectively perceived mental fatigue 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 mental fatigue will be assessed with a Visual Analogue Scale (VAS). The VAS used for this study ranges from 0 (none) to 100 points (strongest mental fatigue imaginable). Question: Please rate the level of your mental fatigue at this moment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Applied Sciences for Health Professions Upper Austria | Recruiting | Linz | Upper Austria | 4020 | Austria |
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| Experimental |
A dynamic office chair (office swivel chair with integrated newly developed pendulum mechanism) 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. |
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| Dynamic Office Chair (office swivel chair with integrated newly developed pendulum mechanism) | 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. |
|
| 6 weeks |
| Mean subjectively rated work performance (after work, weekly average) estimated by VAS | Participants will rate their subjectively perceived working performance 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 working performance will be assessed with a Visual Analogue Scale (VAS). The VAS used for this study ranges from 0 (not productive at all) to 100 points (very productive). Question: Please rate the level of your working performance on this working day. | 6 weeks |
| Change in impact of pain on the daily life (pre vs. post intervention) estimated by ODI-D | Participants will rate their subjectively perceived pain with the German version of the Oswestry Disability Index (ODI-D) at the baseline and post-intervention visits. The ODI-D coverts 10 items: Pain intensity, Personal care, Lifting, Walking, Sitting, Standing, Sleeping, Sex (if applicable), Social and Travel. Each item consists of 6 statements which are scored from 0 (lowest disability) to 5 (highest disability). | 6 weeks |
| Usability estimated using the UEQS questionnaire | Subjects will rate the usability of the dynamic chair with the German version of the User Experience Questionnaire-Short version (UEQ-S) at the relevant post-intervention visit. The UEQ-S cover both classical usability aspects (efficiency, perspicuity, dependability) and user experience aspects (originality, stimulation). It consists of 8 items, each rated on a seven-point scale with a ranked order. The endpoints of the items are (left to right): obstructive to supportive / complicated to easy / inefficient to efficient / confusing to clear / boring to exciting / not interesting to interesting / conventional to inventive and usual to leading edge. | 6 weeks |
| Sitting behaviors estimated by microcontrollers | The usage of the interventional chair will be tracked (i.e., the system cannot detect which person is sitting on it) by means of a microcontroller to determine if the dynamic chair was used or replaced within the interventional period. | 6 weeks |
| Number of adverse events estimated from an AEs form sheet | In the diary and at all study visits participants will be asked for new adverse events. | 16 weeks |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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