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Effect of Dynamic Sitting on Pain Development (DynSit-Pain)

Primary Purpose

Lower Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Dynamic office chair
Sponsored by
University of Applied Sciences for Health Professions Upper Austria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lower Back Pain focused on measuring Sedentary Behavior, Occupational Diseases, Pain Developer, Lower Back Pain, Office Environments

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Applied Sciences for Health Professions Upper AustriaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A (control first)

Arm B (intervention first)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in impact of pain on daily life (pre- vs. post-intervention) estimated with the German version of the Oswestry Disability Index (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).
Mean change in subjectively perceived mental fatigue (pre- vs. post-work, weekly average) estimated via Visual Analogue Scale (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.
Mean subjectively rated working performance (post-work, weekly average) estimated via 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.
Change in quality of life (pre- vs. post-intervention) estimated via 5-level EuroQol quality of life questionnaire (EQ-5D-5L)
Participants will rate their subjectively perceived quality of life with the German version of the EQ-5D-5L at the baseline and post-intervention visits. The EQ-5D-5L covers 5 Dimensions: Mobility, Self-care, Usual activities, Pain/discomfort and Anxiety/depression. Each dimension consists of 5 levels ranging from level 1 (no problems/pain/anxiety) to level 5 (extreme problems/pain/anxiety). It also includes a vertical visual analog scale with a range from 0 (worst imaginable health state) to 100 points (best imaginable health state).
User's experience estimated with the User Experience Questionnaire-Short version (UEQ-S)
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.
User's experience via qualitative interview
The first five participants using the dynamic chair will be contacted for a qualitative interview regarding the user experience and usability of dynamic sitting. This interview will last for about 60 minutes. After five interviews the data will be analyzed, and the collection will be ceased if data saturation is reached, or else the other 5 participants will be interviewed as well.
Number of adverse events (AE) estimated via an adverse event form sheet
In the diary and at all study visits participants will be asked for new adverse events.
Sitting behaviors estimated via 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.

Full Information

First Posted
December 5, 2022
Last Updated
December 15, 2022
Sponsor
University of Applied Sciences for Health Professions Upper Austria
Collaborators
Bergardi GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05664776
Brief Title
Effect of Dynamic Sitting on Pain Development
Acronym
DynSit-Pain
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Applied Sciences for Health Professions Upper Austria
Collaborators
Bergardi GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain
Keywords
Sedentary Behavior, Occupational Diseases, Pain Developer, Lower Back Pain, Office Environments

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (control first)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B (intervention first)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Dynamic office chair
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change in subjectively perceived lower back pain as determined with a Visual Analogue Scale (VAS)
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in impact of pain on daily life (pre- vs. post-intervention) estimated with the German version of the Oswestry Disability Index (ODI-D)
Description
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).
Time Frame
6 weeks
Title
Mean change in subjectively perceived mental fatigue (pre- vs. post-work, weekly average) estimated via Visual Analogue Scale (VAS)
Description
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.
Time Frame
6 weeks
Title
Mean subjectively rated working performance (post-work, weekly average) estimated via VAS
Description
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.
Time Frame
6 weeks
Title
Change in quality of life (pre- vs. post-intervention) estimated via 5-level EuroQol quality of life questionnaire (EQ-5D-5L)
Description
Participants will rate their subjectively perceived quality of life with the German version of the EQ-5D-5L at the baseline and post-intervention visits. The EQ-5D-5L covers 5 Dimensions: Mobility, Self-care, Usual activities, Pain/discomfort and Anxiety/depression. Each dimension consists of 5 levels ranging from level 1 (no problems/pain/anxiety) to level 5 (extreme problems/pain/anxiety). It also includes a vertical visual analog scale with a range from 0 (worst imaginable health state) to 100 points (best imaginable health state).
Time Frame
6 weeks
Title
User's experience estimated with the User Experience Questionnaire-Short version (UEQ-S)
Description
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.
Time Frame
6 weeks
Title
User's experience via qualitative interview
Description
The first five participants using the dynamic chair will be contacted for a qualitative interview regarding the user experience and usability of dynamic sitting. This interview will last for about 60 minutes. After five interviews the data will be analyzed, and the collection will be ceased if data saturation is reached, or else the other 5 participants will be interviewed as well.
Time Frame
6 weeks
Title
Number of adverse events (AE) estimated via an adverse event form sheet
Description
In the diary and at all study visits participants will be asked for new adverse events.
Time Frame
16 weeks
Title
Sitting behaviors estimated via microcontrollers
Description
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.
Time Frame
During the 6 weeks of the period of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernhard Schwartz, Dr. BSc MSc
Phone
+435034420031
Email
bernhard.schwartz@fhgooe.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard Schwartz, Dr. BSc MSc
Organizational Affiliation
FH Gesundheitsberufe OÖ
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Applied Sciences for Health Professions Upper Austria
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhard Schwartz, Dr. MSc BSc
Phone
+43 50 344 20031
Email
bernhard.schwartz@fhgooe.ac.at
First Name & Middle Initial & Last Name & Degree
Renate Ruckser-Scherb, Dr. MSc MEd
Phone
+43 50 344 23128
Email
renate.ruckser@fhgooe.ac.at
First Name & Middle Initial & Last Name & Degree
Bernhard Schwartz, Dr. MSc BSc
First Name & Middle Initial & Last Name & Degree
Sebastian Rosendahl-Huber, MScN BScN

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Dynamic Sitting on Pain Development

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