Effect of Interferential Electrical Stimulation on Pain Perception and Disability Level on Interstitial Cystitis

Interstitial Cystitis Clinical Trial

— IF  

Official title:

Effect of Interferential Electrical Stimulation on Pain Perception and Disability Level on Interstitial Cystitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844581
• Other study ID #: CairoU6
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: February 13, 2019

Study information

• Verified date: February 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 13, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Device:
• interferential current
Treatment was applied using four vacuum electrodes with wet sponge, two of them were put under the patient lumber region on a distance from lumber spinous process by five cm on each side and the other two were applied over the suprapubic region parallel to iliac crest.

Drug:
• Propiverine Hydrochloride
propiverine hydrochloride 20 mg/once per day in the morning

Locations

Country	Name	City	State
Egypt	Al Azhar University	Cairo
Egypt	Faculty of physical therapy- Cairo University	Giza	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale	pain was assessed by the visual analogue scale to all participants in both two groups (A, B)	8 weeks
Secondary	O'Leary-Sant Symptom Index or Interstitial Cystitis Index (ICSI)	It is useful in assessing baseline symptoms (including pain, frequency, nocturia and impact on activities) and effectiveness of treatments. The Interstitial Cystitis Problem Index (ICPI) documents symptom bother.	8 weeks
Secondary	Plasma cortisol concentration	5 ml of venous blood were drawn from the patient at the morning (at 9 am), put into a tube to measures the level of cortisol in the blood.	8 weeks