Lower Back PainDynSit-PainNCT05664776
Effect of Dynamic Sitting on Pain Development
A study testing Dynamic office chair in people with Lower Back Pain, run by University of Applied Sciences for Health Professions Upper Austria at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- Dynamic office chair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteAustria
- Study dates
- 5 Dec 2022to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
University of Applied Sciences for Health Professions Upper Austria
Linz, Upper Austria, 4020
About this study
Official title: Effect of Dynamic Sitting on Pain Development in Adult Pain Developers in Sedentary Environments - a Randomized Controlled Cross-over Trial
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.
Read the 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
- Being tested
- Dynamic office chair
- Keywords
- Sedentary Behavior, Occupational Diseases, Pain Developer, Lower Back Pain, Office Environments
- Medical subject headings
- Low Back Pain, Sedentary Behavior, Occupational Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic office chairDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Dynamic office chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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).
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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).
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 16 weeks
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.
Measured: During the 6 weeks of the period of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start5 Dec 2022
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences for Health Professions Upper Austria
- Sponsor type
- University, hospital or other
- Collaborators
- Bergardi GmbH
- Responsible party
- Principal investigator, Bernhard Schwartz, University of Applied Sciences for Health Professions Upper Austria
- Investigators
- Bernhard Schwartz, Dr. BSc MSc, Principal investigator, FH Gesundheitsberufe OÖ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664776
- Sponsor's protocol ID
- DynSit-Pain
- Acronym
- DynSit-Pain
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dynamic Sitting on Pain Development in Adult Pain Developers in Sedentary Environments - a Randomized Controlled Cross-over Trial
- ClinicalTrials.gov ID
- NCT05664776
- Acronym / sponsor ID
- DynSit-Pain / DynSit-Pain
- Conditions
- Lower Back Pain
- Keywords
- Sedentary Behavior, Occupational Diseases, Pain Developer, Lower Back Pain, Office Environments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Applied Sciences for Health Professions Upper AustriaUniversity, hospital or other
- Collaborators
- Bergardi GmbH
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (control first) | Experimental | Device: Dynamic office chairThe 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 B (intervention first) | Experimental | Device: Dynamic office chairA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic office chairThe 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. | Device | Arm A (control first), Arm B (intervention first) |
Primary outcome
Mean change in subjectively perceived lower back pain as determined with a Visual Analogue Scale (VAS)
Time frame: 6 weeks
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.
8 secondary outcomes
Change in impact of pain on daily life (pre- vs. post-intervention) estimated with the German version of the Oswestry Disability Index (ODI-D)
Time frame: 6 weeks
Mean change in subjectively perceived mental fatigue (pre- vs. post-work, weekly average) estimated via Visual Analogue Scale (VAS)
Time frame: 6 weeks
Mean subjectively rated working performance (post-work, weekly average) estimated via VAS
Time frame: 6 weeks
Change in quality of life (pre- vs. post-intervention) estimated via 5-level EuroQol quality of life questionnaire (EQ-5D-5L)
Time frame: 6 weeks
User's experience estimated with the User Experience Questionnaire-Short version (UEQ-S)
Time frame: 6 weeks
User's experience via qualitative interview
Time frame: 6 weeks
Number of adverse events (AE) estimated via an adverse event form sheet
Time frame: 16 weeks
Sitting behaviors estimated via microcontrollers
Time frame: During the 6 weeks of the period of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Schwartz, Dr. BSc MSc principal investigator
FH Gesundheitsberufe OÖ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic office chair in people with Lower Back Pain, run by University of Applied Sciences for Health Professions Upper Austria at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in subjectively perceived lower back pain as determined with a Visual Analogue Scale (VAS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.