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临床试验/NCT07465068
NCT07465068已完成不适用

The Effect of Visceral Osteopathic Manual Therapy in Chronic Lumbar Disc Herniation

Istanbul Rumeli University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年4月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
World Health Organization Quality of Life Instrument (WHOQOL):

研究概览

简要总结

This study aims to investigate the impact of adding visceral osteopathic manual therapy techniques to conservative physical therapy on the lives of individuals with lumbar disc herniation.

详细描述

Chronic lumbar disc herniation is a very common problem. The aim of our study is to evaluate the effectiveness of visceral manual therapy in addition to classical physical therapy applications used in the treatment of chronic lumbar disc herniation problems. For this purpose, 40 patients diagnosed with chronic lumbar disc herniation who applied to the clinic will be divided into 2 groups, with 20 participants in each group. Participants will be randomly assigned to two groups using a randomization method: Classical Treatment Group (n=20) and Classical Treatment + Visceral Osteopathic Manual Therapy (VOMT) Group (n=20). Sessions will be administered by the same physiotherapist, with a session duration of 30 minutes, every other day, for a total of 5 sessions.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being over 18 years of age
  • Having chronic lumbar disc herniation
  • Being able to communicate in Turkish
  • Being willing to participate in the study

排除标准

  • Spinal Slippage
  • Spinal Stenosis
  • Having an Internal Fixator Implanted
  • Having Acute Back Pain
  • Having a Traumatic Injury
  • Having Previous Surgery
  • Being Over 70 Years Old
  • Being Pregnant and Having Internal Organ Disease

研究组 & 干预措施

group 1: FTR+ VOMT

Active Comparator

Following conservative physical therapy, the FTR+VOMT group will receive visceral osteopathic manual therapy techniques including: CV4 Technique, Segmental Release, Hormonal Axis (Pituitary, Thyroid, Diaphragm), Liver and Stomach Mobilization, Pylor Sphincter and Ligament Hepato-gastricus Mobilization, Odi Sphincter Mobilization, Ilio-jejunum Sphincter Mobilization, Ilio-cecal Valve Mobilization, and Bowel and Colon Mobilization. These applications will be performed in 5 sessions, with one day in between. Each session will be 30 minutes long and performed by the same physiotherapist.

干预措施: osteopathic manual therapy (Other)

group 2

Other

Group 2 will receive the same conservative physical therapy treatments as the VOMT group, for the same duration, but will not include manual therapy.

干预措施: FTR (Other)

结局指标

主要结局

World Health Organization Quality of Life Instrument (WHOQOL):

时间窗: The first assessment was conducted before the first session, a total of 5 sessions were administered with one day skipped, and the second assessment was conducted after the fifth session.

It is a scale developed by the World Health Organization (WHO) and used to assess health-related quality of life. This scale is a comprehensive tool for evaluating individuals' physical, psychological, social, and environmental health status. WHOQOL is used in many areas such as health service planning, health policy development, clinical research, and evaluating the effectiveness of health services.The higher the score, the higher the life satisfaction. The Physical Health subscale has a minimum score of 7 and a maximum score of 35. The Psychological subscale has a minimum score of 6 and a maximum score of 30. The Social Relationships subscale has a minimum score of 3 and a maximum score of 15. The Environment subscale has a minimum score of 8 and a maximum score of 40.

Visual Analog Scale

时间窗: The first assessment was conducted before the first session, a total of 5 sessions were administered with one day skipped, and the second assessment was conducted after the fifth session.

The VAS (Variable Rate of Pain) is used to subjectively assess pain intensity, typically expressed on a scale of 0 to 10. 0 indicates the absence of pain, while 10 represents the most severe pain. This scale helps patients visually understand and express the intensity of their pain. A higher numerical value indicates a higher level of pain, while a lower numerical value suggests a more positive outcome for the patient.

Quebec Functional Scale of Lower Back Pain

时间窗: The first assessment was conducted before the first session, a total of 5 sessions were administered with one day skipped, and the second assessment was conducted after the fifth session.

It is a scale used to assess the severity, impact, and functional capacity of lower back pain. It is based on patient reports and evaluates daily living activities, mobility, and quality of life. The minimum score is 20, and the maximum score is 100. Higher scores are associated with a higher percentage of disability.

次要结局

  • y balance test(The first assessment was conducted before the first session, a total of 5 sessions were administered with one day skipped, and the second assessment was conducted after the fifth session.)

研究者

发起方
Istanbul Rumeli University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Hakkı Boyu

principal investigator physiotherapist

Istanbul Rumeli University

研究点 (1)

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