Clinical trial NCT03844581: Effect of Interferential Electrical Stimulation on Pain Perception and Disability Level on Interstitial Cystitis
Official title: Effect of Interferential Electrical Stimulation on Pain Perception and Disability Level on Interstitial Cystitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Cystitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 40 volunteers women with a diagnosis of interstitial cystitis. Their ages ranged from 25 to 40 years old; their body mass index was \> 30 kg/m2 and were randomly assigned to a group (A) received interferential current at the lower abdomen, and also received traditional medicine or group (B) received traditional medicine for 8 successive weeks.
Primary purpose: TREATMENT

Brief summary: A total of 40 volunteers women with a diagnosis of interstitial cystitis. Their ages ranged from 25 to 40 years old; their body mass index was \> 30 kg/m2 and were randomly assigned to a group (A) received interferential current at the lower abdomen, and also received traditional medicine or group (B) received traditional medicine for 8 successive weeks. Both of the groups received the treatment program for 8 successive weeks. Assessment of pain perception and disability level for all patients in both groups (A\&B) were done through Visual analogue scale, O'Leary-Sant Symptom Index or Interstitial Cystitis Index (ICSI) and blood cortisol concentration were done before and after the treatment program.

Detailed description: Forty volunteers women diagnosed clinically by gynecologist as painful bladder syndrome were participated in this study. They were selected randomly from the gynecological outpatient clinic, at Al-Zahra Universal Hospital, Al Azhar University, their ages ranged from 25 to 40 years and their body mass index was \> 30 kg/m2. All participants complain from suprapubic pain related to bladder filling, accompanied by other symptoms such as increased daytime and night-time frequency. Exclusion criteria of the study were as follows: Participant who had acute viral disease, acute tuberculosis and mental disorders, benign or malignant tumors of the pelvic region, Participant who had active endometriosis or having artificial pacemaker or cardiac arrhythmia, Participant who had sensory disturbances.

Participants were assigned randomly used sealed envelope into two groups (A\&B) equally in number. Group (A): Consisted of twenty patients suffering from painful bladder syndrome. They received interferential current at the lower abdomen, and also received traditional medicine (they were administered anticholinergics (propiverine hydrochloride 20 mg/once per day in the morning) for 8 successive weeks. Group (B): Consisted of twenty patients suffering from painful bladder syndrome. They received traditional medicine (they were administered anticholinergics (propiverine hydrochloride 20 mg/once per day in the morning) for 8 successive weeks

Eligibility criteria: Inclusion Criteria:

* their ages ranged from 25 to 40 years.
* their body mass index was \> 30 kg/m2

Exclusion Criteria:

* Participant who had acute viral disease.
* acute tuberculosis
* mental disorders.
* benign or malignant tumors of the pelvic region

Primary outcomes:
measure: Visual analogue scale
timeFrame: 8 weeks
Secondary outcomes:
measure: O'Leary-Sant Symptom Index or Interstitial Cystitis Index (ICSI)
timeFrame: 8 weeks
measure: Plasma cortisol concentration
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy- Cairo University
state: Dokki
city: Cairo
country: Egypt
facility: Al Azhar University
Study officials:
affiliation: Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt.
name: ghada eb elrefaye, professor
role: PRINCIPAL_INVESTIGATOR
References: