- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07533617
Chair-Integrated Foam Modifications in Coccydynia
Ergonomic Effects of Material- and Geometry-Modified, Chair-Integrated Foams on Pressure Distribution, Pain, and Sitting Comfort in Individuals With Coccydynia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants aged 18-65 years who work at a desk for at least 5-6 hours per day will be included in the study. Information such as age, height, body weight, education level, family type, smoking status, sex, marital status, working posture (sitting, standing, or both), duration of working hours, job type (production or administrative), regular exercise habits, presence of chronic diseases, and absence of any spinal problems (e.g., no diagnosed lumbar disc herniation) will be recorded. Participants will be randomly assigned to six groups. Before using the chairs, participants will be seated on a load cell-equipped chair to assess weight distribution. The distribution of body weight across different regions while sitting will be recorded in kilograms. This measurement will be repeated three times, and the average will be recorded.
After the measurement, participants will be provided with specially designed chairs and asked to work using these chairs. Six different chair designs will be developed for the study. The reason for having six types of chairs is that the foam properties used in each chair will differ from one another.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Konya, Turkey (Türkiye), 42030
- KTO Karatay University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 18 and 65 years
- Working at a desk for at least 5-6 hours per day
- Experiencing coccydynia (tailbone pain)
- Able to sit independently without assistive support
- No diagnosed spinal disorders (e.g., lumbar disc herniation)
- Willing to use the assigned chair during working hours for 1 week
- Able to understand and complete questionnaires
- Provided written informed consent
Exclusion Criteria:
- History of spinal surgery
- Diagnosed spinal disorders (e.g., lumbar disc herniation, scoliosis, severe degenerative spine disease)
- Neurological disorders affecting posture, sitting balance, or sensation
- Severe musculoskeletal conditions (e.g., hip or pelvic disorders) that may affect sitting
- Pregnancy
- Inability to sit for prolonged periods
- Use of assistive seating devices (e.g., orthopedic cushions) during the study period
- Regular use of pain medication that may affect outcome measures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1: Chair with Foam Type A
Participants will use ergonomically modified chair A with different foam properties during their working hours.
|
Participants will use ergonomically modified chairs with different foam properties during their working hours.
|
|
Experimental: Group 2: Chair with Foam Type B
Participants will use ergonomically modified chair B with different foam properties during their working hours.
|
Participants will use ergonomically modified chairs with different foam properties during their working hours.
|
|
Experimental: Group 3: Chair with Foam Type C
Participants will use ergonomically modified chair C with different foam properties during their working hours.
|
Participants will use ergonomically modified chairs with different foam properties during their working hours.
|
|
Experimental: Group 4: Chair with Foam Type D
Participants will use ergonomically modified chair D with different foam properties during their working hours.
|
Participants will use ergonomically modified chairs with different foam properties during their working hours.
|
|
Experimental: Group 5: Chair with Foam Type E
Participants will use ergonomically modified chair E with different foam properties during their working hours.
|
Participants will use ergonomically modified chairs with different foam properties during their working hours.
|
|
Experimental: Group 6: Chair with Foam Type F
Participants will use ergonomically modified chair F with different foam properties during their working hours.
|
Participants will use ergonomically modified chairs with different foam properties during their working hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Distribution Measurement (Load Cell-Equipped Chair System)
Time Frame: Baseline + 1 week
|
Assessment of sitting pressure distribution across right, left, and central regions in kilograms using a custom-designed load cell-integrated chair.
|
Baseline + 1 week
|
|
Paris Questionnaire
Time Frame: Baseline + 1 week
|
Evaluation of pain and functional status associated with coccydynia.
|
Baseline + 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Extended Nordic Musculoskeletal Questionnaire (NMQ-E)
Time Frame: Baseline + 1 week
|
Evaluation of musculoskeletal symptoms related to different body regions.
|
Baseline + 1 week
|
|
EuroQol Quality of Life Scale (EQ-5D-3L)
Time Frame: Baseline + 1 week
|
Assessment of general health-related quality of life.
|
Baseline + 1 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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