The Effects of Balanced Seating Pressure on Pelvic Asymmetry: A Pilot Study

NCT07062510 | Recruiting

• 1 other identifier: 2303070089
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the DaSuit® cushion helps reduce discomfort caused by sitting in adults with non-specific low back pain. It will also assess the safety and physical effects of using the DaSuit® cushion. The main questions it aims to answer are:

1. 1.Does the DaSuit® cushion distribute the pressure evenly on both under-buttock pressure compared to a placebo cushion?
2. 2.Does the DaSuit® cushion improve spinal alignment compared to a placebo cushion?
3. 3.What discomfort or adverse events do participants experience when using the DaSuit® cushion?
4. 4.Use the DaSuit® cushion or a placebo cushion in a randomized order, with each sitting session lasting 10 minutes
5. 5.Complete both conditions with a 10-minute washout period between sessions
6. 6.Sit on a standardized wooden chair with a pressure sensor mat placed on the cushion surface
7. 7.Keep a fixed posture with hips, knees, and ankles at approximately 90 degrees
8. 8.Watch a 10-minute video on a tablet positioned 30-40 cm in front of them at a 5-10 degree downward angle to maintain a steady gaze
9. 9.Undergo spinal imaging immediately after each session, maintaining the same seated posture
10. 10.Report any discomfort or pain experienced during or after each session

Conditions

Lower Back Pain; Scoliosis Patients

Keywords

sitting pressure; Under-Buttocks Pressure; Dasuit; Pelvic asymmetry; Spinal alignment deviation (SAD)

Outcome Measures

Primary Outcomes (2)

• Pelvic height discrepancy (PHD)

  Measurement of the distance between the horizontal lines at the highest points of the bilateral iliac crests on the post-intervention whole spine radiographic imaging.

  Periprocedural

• Right and Left peak pressures

  This study will utilize the Sensing Tex® Seating Mat Dev Kit 1.9, a high-resolution textile-based pressure sensing system. The mat consists of a 16 × 16 matrix of 256 round sensor elements with a spatial resolution of 20 mm, embedded in a flexible textile structure. It is designed to be non-intrusive and can be placed directly between the seat surface and the participant without affecting comfort or posture. Right and left peak pressure values are determined by identifying the highest recorded pressure within the respective right and left hemispheres of the sensing matrix, defined relative to the midline axis of the mat. This bilateral analysis enables precise quantification of side-to-side pressure imbalance.

  Periprocedural

Secondary Outcomes (6)

• Shoulder height discrepancy

  Periprocedural

• Spinal alignment deviation

  Periprocedural

• X and Y coordinates of the center of pressure (mmHg) and Right/Left peak pressures

  Periprocedural

• Total contact area

  Periprocedural

• Area of values above 75% of the peak pressure

  Periprocedural

Study Arms (2)

Dasuit to Placebo

OTHER

This group of patients will first undergo Dasuit intervention then Placebo intervention

Device: Dasuit Cusion; Device: Placebo; Other: Washout

Placebo to Dasuit

OTHER

This group of patients will first undergo Placebo intervention then Dasuit intervention

Device: Dasuit Cusion; Device: Placebo; Other: Washout

Interventions

Dasuit Cusion DEVICE

The Dasuit cushion is placed on a 40X40X40 wooden box as a chair, and the pressure seating mat is placed on the cushion. Participants were asked to sit on the cushion with hips, knees, and ankles positioned at approximately 90° angles at ease. A tablet was mounted in front of the chair at 30-40 cm from the eyes and at a downward viewing angle of 5-10 degrees. Participants were instructed to watch a 10-minute video to maintain a fixed gaze and minimize head movement. The patient was to sit on the cushion at ease for 1 minute to adjust to the cushion, then under-buttock pressure was recorded for 10 mins.

Dasuit to Placebo; Placebo to Dasuit

Placebo DEVICE

The placebo cushion is placed on a 40X40X40 wooden box as a chair, and the pressure seating mat is placed on the cushion. Participants were asked to sit on the cushion with hips, knees, and ankles positioned at approximately 90° angles at ease. A tablet was mounted in front of the chair at 30-40 cm from the eyes and at a downward viewing angle of 5-10 degrees. Participants were instructed to watch a 10-minute video to maintain a fixed gaze and minimize head movement. The patient was to sit on the cushion at ease for 1 minute to adjust to the cushion, then under-buttock pressure was recorded for 10 mins.

Dasuit to Placebo; Placebo to Dasuit

Washout OTHER

A 10 min washout period is in between the two interventions. The paitent is asked to walk around at ease.

Dasuit to Placebo; Placebo to Dasuit

Eligibility Criteria

• Age: 20 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• adults aged 20 to 50 years
• adults had low back pain non-specific but exacerbated by sitting with VAS score between 3-7
• body height between 150-180 cm
• BMI between 18.5-24
• a radiographically verified hemi-pelvic height discrepancy of ≥ 0.3 cm in sitting posture
• willing to participate and cooperate throughout the whole intervention session

You may not qualify if:

• inability to sit for 20 minutes
• MMSE \< 24
• significant spinal/pelvic disorders (e.g., fractures, surgeries, herniated discs with nerve compression)
• scoliosis with Cobb angle ≥ 20°
• recent use of pain killers and/or muscle relaxants
• pregnancy
• skin conditions affecting sitting tolerance.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Taoyuan Chang Gung Memorial Hospital

Taoyuan District, Taiwan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

WASH protein, Drosophila

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yu-Cheng Pei, M.D, PhD.

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Central Study Contacts

Wei-Han Chang, M.D., PhD.

CONTACT

+886 975365711; weihan7252@gmail.com

Hander Wang, M.D.

CONTACT

+886 975366879; superr401@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 14, 2025
• Study Start: September 12, 2025
• Primary Completion: March 27, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: January 27, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 12 months post-publication and available for 3 years.
• Access Criteria: Available to qualified investigators for academic use upon approval of a research proposal and signed data-sharing agreement.

Locations

TW (1)