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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Interstitial Cystitis

Intervention / Treatment
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* Device: interferential current
* Drug: Propiverine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: interferential current<br>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 | Device: interferential current<br>* 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.<br>|
| Active Comparator: anticholinergics<br>anticholinergics (propiverine hydrochloride 20 mg/once per day in the morning) for 8 successive weeks | Drug: Propiverine Hydrochloride<br>* propiverine hydrochloride 20 mg/once per day in the morning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | pain was assessed by the visual analogue scale to all participants in both two groups (A, B) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |