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

NCT03844581 | Completed

• 1 other identifier: CairoU6
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale

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

  8 weeks

Secondary Outcomes (2)

• O'Leary-Sant Symptom Index or Interstitial Cystitis Index (ICSI)

  8 weeks

• Plasma cortisol concentration

  8 weeks

Study Arms (2)

interferential current

ACTIVE COMPARATOR

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

anticholinergics

ACTIVE COMPARATOR

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

Drug: Propiverine Hydrochloride

Interventions

interferential current 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.

interferential current

Propiverine Hydrochloride DRUG

propiverine hydrochloride 20 mg/once per day in the morning

anticholinergics

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• their ages ranged from 25 to 40 years.
• their body mass index was \> 30 kg/m2

You may not qualify if:

• Participant who had acute viral disease.
• acute tuberculosis
• mental disorders.
• benign or malignant tumors of the pelvic region

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Faculty of physical therapy- Cairo University

Giza, Dokki, 12613, Egypt

Location

Al Azhar University

Cairo, 11599, Egypt

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Electric Stimulation Therapy; propiverine

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• ghada eb elrefaye, professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants were assigned randomly used sealed envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 18, 2019
• Study Start: January 1, 2019
• Primary Completion: January 1, 2019
• Study Completion: February 13, 2019
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

EG (2)