The Effects of Balanced Seating Pressure on Pelvic Asymmetry in Under-Buttocks Pressure, Spinal Alignment, and Lower Back Pain: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pelvic height discrepancy (PHD)
研究概览
简要总结
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:
- Does the DaSuit® cushion distribute the pressure evenly on both under-buttock pressure compared to a placebo cushion?
- Does the DaSuit® cushion improve spinal alignment compared to a placebo cushion?
- 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:
- Use the DaSuit® cushion or a placebo cushion in a randomized order, with each sitting session lasting 10 minutes
- Complete both conditions with a 10-minute washout period between sessions
- Sit on a standardized wooden chair with a pressure sensor mat placed on the cushion surface
- Keep a fixed posture with hips, knees, and ankles at approximately 90 degrees
- 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
- Undergo spinal imaging immediately after each session, maintaining the same seated posture
- Report any discomfort or pain experienced during or after each session
详细描述
Trial Design This study is designed as a randomized, double-blind, placebo-controlled, two-period crossover trial to be conducted at the Department of Rehabilitation, Taoyuan Chang Gung Memorial Hospital. A total of 24 participants will be screened, with an estimated 20 completing the full protocol. Participants will be randomly assigned to one of two treatment sequences: Group A will receive the DaSuit® cushion followed by the placebo cushion; Group B will receive the placebo cushion followed by the DaSuit® cushion. Each intervention period will last approximately 10 minutes, separated by a 10-minute washout interval to minimize potential carry-over effects. The crossover design is chosen to reduce between-subject variability, as each participant will serve as their own control.
Participants The study will not involve patients or the public in the design, conduct, reporting, or dissemination.
Inclusion criteria are as follows: (1) adults aged 20 to 50 years; (2) experiencing non-specific low back pain exacerbated by sitting, with a VAS score between 3 and 7; (3) height between 150-180 cm; (4) BMI between 18.5-24; and (5) radiographically verified hemi-pelvic height discrepancy ≥ 0.5 cm in a seated posture.
Exclusion criteria include: (1) inability to sit for 20 minutes; (2) MMSE < 24; (3) significant spinal or pelvic disorders (e.g., fractures, prior surgeries, herniated discs with nerve compression); (4) diagnosed scoliosis with a Cobb angle ≥ 20°; (5) recent use of analgesics or muscle relaxants; (6) pregnancy; and (7) skin conditions affecting sitting tolerance. All participants will provide written informed consent following clinical pelvic examination confirming asymmetry.
Interventions Each participant will undergo both intervention conditions in a randomized order. In each session, the participant will sit for 10 minutes on either the DaSuit® cushion or the placebo cushion, placed on a standardized 40×40×40 cm wooden chair. A pressure sensor mat will be placed on the cushion surface to measure under-buttock pressure. Following the sitting period, pain intensity will be assessed using the VAS, and an anterior-posterior full-spine X-ray will be taken. After a 10-minute washout period-during which the participant will be instructed to walk-the alternate cushion condition will be administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •inability to sit for 20 minutes
- •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
- •skin conditions affecting sitting tolerance.
研究组 & 干预措施
Dasuit to Placebo
This group of patients will first undergo Dasuit intervention then Placebo intervention
干预措施: Washout (Other)
Placebo to Dasuit
This group of patients will first undergo Placebo intervention then Dasuit intervention
干预措施: Washout (Other)
Placebo to Dasuit
This group of patients will first undergo Placebo intervention then Dasuit intervention
干预措施: Dasuit Cusion (Device)
Placebo to Dasuit
This group of patients will first undergo Placebo intervention then Dasuit intervention
干预措施: Placebo (Device)
Dasuit to Placebo
This group of patients will first undergo Dasuit intervention then Placebo intervention
干预措施: Dasuit Cusion (Device)
Dasuit to Placebo
This group of patients will first undergo Dasuit intervention then Placebo intervention
干预措施: Placebo (Device)
结局指标
主要结局
Pelvic height discrepancy (PHD)
时间窗: Periprocedural
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.
Right and Left peak pressures
时间窗: Periprocedural
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.
次要结局
- 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)
- Visual Analog Pain Scale(Periprocedural)
