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

• ClinicalTrials.gov Identifier: NCT03844581
• Recruitment Status: Completed
• First Posted: February 18, 2019
• Last Update Posted: February 19, 2019
• Sponsor: Cairo University
• Information provided by (Responsible Party): Ghada Ebrahim El Refaye, Cairo University

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Egypt

Faculty of physical therapy- Cairo University

Giza, Dokki, Egypt, 12613

Al Azhar University

Cairo, Egypt, 11599

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: ghada eb elrefaye, professor; Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt.

More Information

• Responsible Party: Ghada Ebrahim El Refaye, assistant professor, Cairo University
• ClinicalTrials.gov Identifier: NCT03844581
• Other Study ID Numbers: CairoU6
• First Posted: February 18, 2019
• Last Update Posted: February 19, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant 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