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

Not Applicable

Completed

• Conditions: Interstitial Cystitis
• Interventions: Device: interferential current; Drug: Propiverine Hydrochloride

• Registration Number: NCT03844581
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-01-01
• Status Verified: 2019-02
• Study Completion: 2019-02-13
• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-15
• Last Update Submitted: 2019-02-16
• Study First Posted: 2019-02-18
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interferential current	interferential current	interferential current with a constant frequency of 100Hz for pain relief, then using rhythmic frequency of 1-100 Hz that help to disperse infiltration and adhesions for 8 successive weeks
anticholinergics	Propiverine Hydrochloride	anticholinergics (propiverine hydrochloride 20 mg/once per day in the morning) for 8 successive weeks

Primary Outcome Measures

Name	Time	Method
Visual analogue scale	8 weeks	pain was assessed by the visual analogue scale to all participants in both two groups (A, B)

Secondary Outcome Measures

Name	Time	Method
O'Leary-Sant Symptom Index or Interstitial Cystitis Index (ICSI)	8 weeks	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.
Plasma cortisol concentration	8 weeks	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.

Trial Locations

Locations (2)

Faculty of physical therapy- Cairo University; 🇪🇬 Giza, Dokki, Egypt

Al Azhar University; 🇪🇬 Cairo, Egypt