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

NCT ID: NCT03844581

Last Updated: 2019-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-02-13

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

Conditions

Interstitial Cystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

interferential current

Intervention Type: DEVICE

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.

anticholinergics

anticholinergics (propiverine hydrochloride 20 mg/once per day in the morning) for 8 successive weeks

Group Type: ACTIVE_COMPARATOR

Propiverine Hydrochloride

Intervention Type: DRUG

propiverine hydrochloride 20 mg/once per day in the morning

Interventions

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.

Intervention Type: DEVICE

Propiverine Hydrochloride

propiverine hydrochloride 20 mg/once per day in the morning

Intervention Type: DRUG

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Ebrahim El Refaye

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ghada eb elrefaye, professor

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt.

Locations

Faculty of physical therapy- Cairo University

Giza, Dokki, Egypt

Al Azhar University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

CairoU6

Identifier Type: -

Identifier Source: org_study_id