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

Primary Purpose

Interstitial Cystitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
interferential current
Propiverine Hydrochloride
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of physical therapy- Cairo University
  • Al Azhar University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

interferential current

anticholinergics

Arm Description

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 20 mg/once per day in the morning) for 8 successive weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 15, 2019
Last Updated
February 16, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03844581
Brief Title
Effect of Interferential Electrical Stimulation on Pain Perception and Disability Level on Interstitial Cystitis
Acronym
IF
Official Title
Effect of Interferential Electrical Stimulation on Pain Perception and Disability Level on Interstitial Cystitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
February 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
Participants were assigned randomly used sealed envelope
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
interferential current
Arm Type
Active Comparator
Arm Description
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
Arm Title
anticholinergics
Arm Type
Active Comparator
Arm Description
anticholinergics (propiverine hydrochloride 20 mg/once per day in the morning) for 8 successive weeks
Intervention Type
Device
Intervention Name(s)
interferential current
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propiverine Hydrochloride
Intervention Description
propiverine hydrochloride 20 mg/once per day in the morning
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
pain was assessed by the visual analogue scale to all participants in both two groups (A, B)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
O'Leary-Sant Symptom Index or Interstitial Cystitis Index (ICSI)
Description
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.
Time Frame
8 weeks
Title
Plasma cortisol concentration
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ghada eb elrefaye, professor
Organizational Affiliation
Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of physical therapy- Cairo University
City
Giza
State/Province
Dokki
ZIP/Postal Code
12613
Country
Egypt
Facility Name
Al Azhar University
City
Cairo
ZIP/Postal Code
11599
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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