Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03844581
Recruitment Status : Completed
First Posted : February 18, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ghada Ebrahim El Refaye, 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.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Device: interferential current Drug: Propiverine Hydrochloride Not Applicable

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
Masking Description: Participants were assigned randomly used sealed envelope
Primary Purpose: Treatment
Official Title: Effect of Interferential Electrical Stimulation on Pain Perception and Disability Level on Interstitial Cystitis
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : February 13, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
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.

Active Comparator: anticholinergics
anticholinergics (propiverine hydrochloride 20 mg/once per day in the morning) for 8 successive weeks
Drug: Propiverine Hydrochloride
propiverine hydrochloride 20 mg/once per day in the morning




Primary Outcome Measures :
  1. Visual analogue scale [ Time Frame: 8 weeks ]
    pain was assessed by the visual analogue scale to all participants in both two groups (A, B)


Secondary Outcome Measures :
  1. O'Leary-Sant Symptom Index or Interstitial Cystitis Index (ICSI) [ Time Frame: 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.

  2. Plasma cortisol concentration [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844581


Locations
Layout table for location information
Egypt
Faculty of physical therapy- Cairo University
Giza, Dokki, Egypt, 12613
Al Azhar University
Cairo, Egypt, 11599
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Principal Investigator: ghada eb elrefaye, professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt.

Layout table for additonal information
Responsible Party: Ghada Ebrahim El Refaye, assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03844581     History of Changes
Other Study ID Numbers: CairoU6
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Propiverine
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents