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临床试验/NCT05537207
NCT05537207已完成不适用

Effect of Laser at Lumbar Sensitized Acupoint on Pain Perception and Quality of Life in Female Chronic Pelvic Pain

October 6 University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
visual analogue scale

研究概览

简要总结

To investigate the effect of low-level laser at lumbar sensitized acupoint on pain perception in chronic pelvic pain. BACKGROUND: chronic pelvic pain is one of the serious problems in the female, resulting in pain and less physical activity.

详细描述

Thirty six females with chronic pelvic pain will participate in this study. The patients will randomly be divided into two equal groups; the control group will receive non-steroidal anti-inflammatory drugs in the form of Brufen (Ibuprofen), 400 mg, 3 times per day after meals, for 6 weeks, as will described by their gynecologist. and the study group received the same treatment and low-level laser at lumbar sensitized Acupoint, three times per week for four weeks. The evaluation methods by visual analogue scale (VAS), pain sensitivity was evaluated by measuring mean values of pressure pain thresholds (PPT) using a Pressure Algometer, while the quality of life was evaluated by the 12-Item Short-Form Health Survey (SF-12) before and after the treatment

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
25 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Thirty six female with chronic pelvic pain
  • Their age ranged from 25 to 40 years old.
  • With the maximum parity number three.
  • Their body mass index (BMI) (20:29.9) kg/m
  • their pain score on the Visual Analog Scale (VAS) above 4 cm
  • Thirty-six married women diagnosed with chronic pelvic pain (CPP)
  • with a prior history of treatment for pelvic inflammatory disease (PID)
  • women with periodic lower abdominal or pelvic pain for at least six months and met -- the clinical diagnostic criteria for PID based on the presence of all three major criteria: lower abdominal tenderness, cervical motion tenderness, and bilateral adnexal tenderness
  • at least one minor supporting criterion: oral temperature >38.3°C (101 °F), mucopurulent cervical discharge or cervical friability, abundant WBCs on saline microscopy of vaginal fluid, elevated ESR and/or CRP, or laboratory-confirmed cervical infection with N.
  • gonorrhoeae or C. trachomatis

排除标准

  • Any difficulty to communicate or understanding program instructions
  • any other conditions that caused pain (for example fibromyalgia and arthritis)
  • any psychiatric or cognitive symptoms
  • any other musculoskeletal disorders or neurologic diseases
  • any other conditions causing pelvic pain (e.g., fibromyalgia, arthritis), history of musculoskeletal or neurological diseases affecting the lower extremities and spine (such as lumbar disc herniation), acute pelvic inflammatory disease (PID), pregnancy or lactation, tumors, pelvic congestion, tuberculous PID, endometriosis, adenomyosis, gynecological tumors, or other gyneco-logical conditions that could contribute to chronic pelvic pain (CPP).
  • any issues at acupoint sites (such as ulcers or skin conditions); impairments in other systems that could lead to pelvic and lumbosacral pain (e.g., digestive, motor, or urinary issues)
  • severe systemic illnesses affecting the hematologic, digestive, urinary, or cardiovascular systems
  • mental illness; cognitive deterioration
  • immune-compromising diseases (such as diabetes or HIV/AIDS); and contraindications to NSAIDs

结局指标

主要结局

visual analogue scale

时间窗: 4 weeks

which assesses pain on a paper sheet scale with an increasing number from 0 (no pain) to 10 (the worst pain imaginable).

Pressure Algometer

时间窗: 4 weeks

pain sensitivity was evaluated by measuring mean values of pressure pain thresholds (PPT) using a Pressure Algometer. it will be used to assess pain sensitivity through identifying the pressure pain threshold (PPT) for all women before and after treatment. It has a standardized 1.52 cm2 flat circular probe that is pushed against the subject until the pain threshold is reached

Short-Form Health Survey

时间窗: 4 weeks

quality of life was evaluated by the 12-Item Short-Form Health Survey (SF-12) before and after the treatment. it is a 12-item questionnaire that was used to assess the quality of life of women in both groups

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lama Saad El-Din Mahmoud

Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

October 6 University

研究点 (1)

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