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

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. Does the DaSuit® cushion distribute the pressure evenly on both under-buttock pressure compared to a placebo cushion?
2. Does the DaSuit® cushion improve spinal alignment compared to a placebo cushion?
3. What discomfort or adverse events do participants experience when using the DaSuit® cushion?

Researchers will compare the DaSuit® cushion to a placebo cushion (a look-alike cushion without therapeutic effect) to see if the DaSuit® cushion works to relieve sitting-induced discomfort.

Participants will:

1. Use the DaSuit® cushion or a placebo cushion in a randomized order, with each sitting session lasting 10 minutes
2. Complete both conditions with a 10-minute washout period between sessions
3. Sit on a standardized wooden chair with a pressure sensor mat placed on the cushion surface
4. Keep a fixed posture with hips, knees, and ankles at approximately 90 degrees
5. 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
6. Undergo spinal imaging immediately after each session, maintaining the same seated posture
7. Report any discomfort or pain experienced during or after each session

Conditions

• Lower Back Pain
• Scoliosis Patients

Interventions

DEVICE

Dasuit Cusion

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.

DEVICE

Placebo

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.

OTHER

Washout

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital

  lead OTHER

Principal Investigators

• Yu-Cheng Pei, M.D, PhD. · Chang Gung Memorial Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

20 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-12

Primary Completion

2026-03-27

Completion

2026-05-15

Countries

• Taiwan

Study Locations