Comparison of the Effectiveness of Chiropractic Manipulation Applied to the Lumbar Sacroiliac Region in Patients With Lumbar Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Pain Intensity (Numeric Pain Rating Scale - NPRS / NRS)
研究概览
简要总结
This study aims to compare the effectiveness of chiropractic manipulation applied to the lumbar and sacroiliac regions in patients with lumbar disc herniation. A total of 45 participants are randomly assigned into three groups (15 per group). The control group (CG) receives conventional physiotherapy, including hot pack, TENS, ultrasound, and exercise. The lumbar group (LG) receives the same physiotherapy program combined with lumbar spinal manipulation. The sacroiliac group (SIG) receives conventional physiotherapy combined with sacroiliac joint manipulation. Outcomes are measured using the Numeric Pain Rating Scale (NPRS), Quebec Back Pain Disability Scale, Tampa Scale for Kinesiophobia, and range of motion (ROM) assessments.
详细描述
This randomized controlled trial investigates the comparative effectiveness of regional chiropractic manipulation in patients diagnosed with lumbar disc herniation. The study includes three groups, each consisting of 15 participants. All groups receive a standard physiotherapy protocol, including hot pack application, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, and exercise therapy.
The Control Group (CG) receives only the standard physiotherapy program. The Lumbar Group (LG) receives standard physiotherapy in combination with lumbar spinal manipulation.
The Sacroiliac Group (SIG) receives standard physiotherapy in combination with sacroiliac joint manipulation.
Interventions are delivered by licensed practitioners following standardized protocols. The study aims to evaluate the effects of region-specific chiropractic manipulations on pain intensity, functional disability, kinesiophobia, and lumbar range of motion. Assessments are conducted at baseline and at the end of the treatment period using validated measurement tools: the Numeric Pain Rating Scale (NPRS), Quebec Back Pain Disability Scale, Tampa Scale for Kinesiophobia, and goniometric range of motion measurements.
By comparing outcomes across these three groups, the study seeks to identify whether regionally targeted chiropractic manipulation enhances the clinical efficacy of conventional physiotherapy in managing lumbar disc herniation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
In this single-blind study, outcome assessments are conducted by an independent physiotherapist who is blinded to group allocation. The outcome assessor is not involved in the treatment sessions and does not have access to group assignment information. Participants and care providers are not blinded due to the nature of the manual interventions applied.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be between the ages of 18 and 65
- •Have been diagnosed with lumbar disc herniation
- •Have signed the voluntary consent form
排除标准
- •Having a value below 4 according to the NAS
- •Having a contraindication to chiropractic manipulation
- •Having a rheumatic disease
- •Having undergone surgery in the lumbar and sacroiliac regions
- •Being pregnant or suspected of being pregnant
- •Having a malignant disease
- •Having severe physical and psychological disorders
- •Having acute fractures of the spine and lower extremities fractures in the lower extremities
- •Individuals with neurological and orthopedic deficits in the lower extremities
结局指标
主要结局
Pain Intensity (Numeric Pain Rating Scale - NPRS / NRS)
时间窗: Baseline and at the end of 2 weeks
Pain intensity will be assessed using the Numeric Pain Rating Scale (0-10), where higher scores indicate more severe pain.
Functional Disability (Quebec Back Pain Disability Scale)
时间窗: Baseline and at the end of 2 weeks
Functional disability due to low back pain will be measured using the Quebec Back Pain Disability Scale. Higher scores indicate greater disability.
次要结局
- Kinesiophobia (Tampa Scale of Kinesiophobia - TSK)(Baseline and at the end of 2 weeks)
- Lumbar Range of Motion (ROM) Measurements(Baseline and at the end of 2 weeks)
研究者
SEFA HAKTAN HATIK
Asst. Professor
Sinop University