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临床试验/NCT06017830
NCT06017830暂停不适用

The Effectiveness of Physical Therapy on Sexual Function in Patients With Low Back Pain

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
60
试验地点
1
主要终点
change from sexual function scores at just after physical therapy and 3 months

研究概览

简要总结

Sexual function in low back pain and after lumbar surgery has been evaluated in many studies In a few studies, sexual function problems after surgery have also been reported. In the literature, there is no study that investigates the effectiveness of physical therapy on sexual function in patients with low back pain. In this study, the effectiveness of physical therapy on sexual function in patients with low back pain will be evaluated.

详细描述

63 patients who had chronic low back pain who applied to City Hospital, Physical Medicine and Rehabilitation Department between January 2021 and January 2023 were enrolled in the study. Sexually active patients between the ages of 18 and 60, for whom physical therapy was planned for low-back pain related to lumbar pathologies, were included in the study. Informed consent was obtained from all patients. Exclusion criteria were defined as having contraindications for any physical therapy agents, having cardiovascular, neurological, psychiatric disease, or sexual disorders.

Short Form-12 (SF-12), Oswestry Disability Index (ODI), and Hospital Anxiety and Depression Scale (HAD) were recorded. International Index of Erectile Function (IIEF) and Female Sexual Function Index (FSFI) were utilized to evaluate sexual function

Fifteen sessions of physical therapy were planned for each patient. The physical therapy program included 15 minutes of conventional transcutaneous electrical nerve stimulation, 10 minutes of ultrasound, and 15 minutes of superficial heaters such as hot packs or infrarouge. All patients were evaluated the day before the first physical therapy session, the one-month and three-month after the last physical therapy session.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • low back pain due to lumbar pathologies
  • being sexually active
  • have no contraindications for physical therapy agents

排除标准

  • known sexual function problems,
  • known psychiatric disease and/or are taking antidepressant
  • diabetes mellitus,
  • cardiovascular disease
  • neurological diseases

结局指标

主要结局

change from sexual function scores at just after physical therapy and 3 months

时间窗: Before, just after and 3 months later physical therapy

Female Sexual Function Index for women and International Index of Erectile Function for men will be used. There is no cut-off values. Better scores mean better results

次要结局

  • change from disability scores at just after physical therapy and 3 months(Before, just after and 3 months later physical therapy)
  • change from mood at just after physical therapy and 3 months(Before, just after and 3 months later physical therapy)
  • change from quality of life at just after physical therapy and 3 months(Before, just after and 3 months later physical therapy)

研究者

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gunay ER

Principal Investigator

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (1)

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