Effect of Interferential Electrical Stimulation on Pain Perception and Disability Level on Interstitial Cystitis (IF)
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|ClinicalTrials.gov Identifier: NCT03844581|
Recruitment Status : Completed
First Posted : February 18, 2019
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Cystitis||Device: interferential current Drug: Propiverine Hydrochloride||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|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|
|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|
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
- Visual analogue scale [ Time Frame: 8 weeks ]pain was assessed by the visual analogue scale to all participants in both two groups (A, B)
- 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.
- 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.
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
|Faculty of physical therapy- Cairo University|
|Giza, Dokki, Egypt, 12613|
|Al Azhar University|
|Cairo, Egypt, 11599|
|Principal Investigator:||ghada eb elrefaye, professor||Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt.|