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临床试验/NCT06837675
NCT06837675尚未招募不适用

Effect of High Tone Power Therapy on Bladder Disturbance in Patients with Multiple Sclerosis

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
over active bladder symptom score (OABSS)

研究概览

简要总结

This study is conducted to investigate the effect of high-tone power therapy on improving bladder function and quality of life in patients with MS.

详细描述

Inflammation, demyelination, gliosis, and neuronal loss are all components of multiple sclerosis (MS), is a chronic autoimmune disease that affects the central nervous system (CNS). Myelinated axons in the CNS are the target of MS attacks, which can cause varying degrees of damage to both myelin and axons ). MS affects 2.3 million people worldwide. MS is often diagnosed between the ages of 20 and 50 years, with females experiencing it more often than males. Among the most common MS symptoms are disorders of motor function and gait, spasticity, and sensory challenges including visual problems

. which are causes of disability that are possible to identify by observing from the outside. However, other frequent and disabling symptoms are invisible, including fatigue, cognitive deficits and decline, emotional distress, and pain. Dysfunction of the bladder and bowel are also hidden consequences of MS but rank among the most frequent and troublesome symptoms. it is estimated that 75-90 % of MS will experience bladder problems and up to 50 % of MS will experience bowel problems at some stage in their life. Bladder dysfunction is reported to cause major limitations in one's daily life, and contribute to decreased satisfaction with one's life situation and health Lesions above the pontine micturition center are usually associated with neurogenic detrusor overactivity (NDO), characterized by involuntary detrusor contractions 3 (urgency, frequency, urge incontinence, and no or low post-void residual urine).

Urgency is the sudden desire and intense sensation of needing to pass urine; frequency is the need to urinate many times during the day or at night (nocturia) or both, but in normal or less-than-normal volumes; urge incontinence is an involuntary urine leak while having symptoms of urgency. High-tone power therapy (HTT) is a unique characteristic of electrotherapy. It uses intermediate frequency, metal-compatible alternating current whose frequency oscillates between approximately 4000 Hz and 33000 Hz and intensity is adjusted, unlike traditional electrotherapies such as TENS. Its main effects are introducing energy into the body to activate cells, producing an oscillation or vibration in the cells and tissues to promote metabolism, normalizing the cell metabolism and nerve regeneration.

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
Single (Participant)

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

  • •Patients diagnosed with MS complaining of bladder disturbance referred by neurologist with a urodynamic study
  • •Patients age will be ranged from 20 to 50 years old
  • •Body mass index from (18.5 to 24.9)
  • •Score of disability 2 to 6 according to EDSS
  • •Patients with overactive bladder at least 6 months before the study
  • •The severity of overactive bladder OAB will range from 6 to 10 according to overactive bladder symptom score (moderate stage) (OABSS).
  • •All the patients will be in the remission period.
  • •All the patients will receive the same medical treatment.
  • •All the drugs that interfere with bladder function will be stopped.
  • •Patients must be medically stable.
  • •Patients able to respond to verbal instructions

排除标准

  • •Unstable cardiac condition (MI, severe cardiac failure)
  • •Systemic diseases (DM, RA, AKI)
  • •Patients with musculoskeletal deformities
  • •Any tumor affects the lumber spine
  • •Patients with cognitive problems 16
  • •Open wound, burn, and loss of sensation
  • •Patients with metal implants
  • •Any other diseases that may cause OAB, such as inflammatory or urinary tract infections, Prostatitis in male or Female genital disorders
  • •Patients with a history of abdominal or bladder surgeries or diseases
  • •MS patients in acute relapse stage
  • •Patients with diabetic polyneuropathy

研究组 & 干预措施

Study group 1

Experimental

twenty patients will receive High tone power therapy and selected physical therapy program 36 sessions 3 times per week for 3 months.

干预措施: high tone power therapy (Device)

Study group 1

Experimental

twenty patients will receive High tone power therapy and selected physical therapy program 36 sessions 3 times per week for 3 months.

干预措施: selected physical therapy program (Other)

Control group 2

Active Comparator

twenty patients will receive a selected physical therapy program only 36 sessions 3 times per week for 3 months.

干预措施: selected physical therapy program (Other)

结局指标

主要结局

over active bladder symptom score (OABSS)

时间窗: the test will be done 3 days before the beginning of the study and 3 days after completion of the study.

Assessment scale for overactive bladder syndrome. It consists of 4 questions about frequency, nocturnal, urgency, and urge incontinence. Total score from 0 to 15

Urodynamic study

时间窗: the test will be done 3 days before the beginning of the study and 3 days after completion of the study.

The urodynamic study is the golden objective for assessing the bladder's physiological and pathological functions. The test involves an invasive assessments of bladder storage function and bladder emptying function

MS bladder check tool

时间窗: the test will be done 3 days before the beginning of the study and 3 days after completion of the study.

it is a check tool that aims to improve the management of people with Multiple sclerosis.

The international Consultation on Incontinence Questionnaire Short Form (ICIQ-UI)

时间窗: the test will be done 3 days before the beginning of the study and 3 days after completion of the study.

The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world.

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

Mohamed Hamdy Hussien Samy

physical therapist

Cairo University

研究点 (1)

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