Comparison of Transcutaneous Electrical Nerve Stimulation and Manual Therapy in Children With Cerebral Palsy

Comparison the Efficiency of Transcutaneous Electrical Nerve Stimulation and Manual Therapy in Children With Cerebral Palsy With Lower Urinary System Dysfunction

There are many studies in the literature on healthy children with lower urinary tract dysfunction (LUTD), but there are limited number of studies in children with cerebral palsy (CP) with LUTD.

This study aim to contribute to the literature by examining the effectiveness of transcutaneous electrical nerve stimulation (TENS) and abdominal massage in the treatment of children with CP with LUTD and comparing the superiority of the two treatment methods to each other.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Neurogenic Bowel; Neurogenic Bladder; Bowel Dysfunction; Bladder Dysfunction
• Intervention / Treatment: Device: TENS; Other: Massage

Detailed Description

CP represents a group of chronic, non-progressive motor disorders characterized by impaired voluntary movement resulting from prenatal developmental abnormalities or perinatal or postnatal central nervous system damage.

The location and extent of neurological damage are important in determining motor and mental disabilities and the severity of the disease. Children with CP can also be affected by other medical disorders such as seizures, mental retardation, hearing, vision and communication problems. The prevalence of CP is approximately 2-3 per 1000 live births. Dysfunctional bowel and urinary dysfunction problems can often accompany CP due to motor, mental, cognitive, sensory and other neurological disorders. Severe motor disorders and/or additional cognitive deficits lead to the development of neurogenic lower urinary tract symptoms. Accoring the data obtained during the outpatient clinic visits, it was determined that most of the children with CP had LUTD complaints such as incontinence, sense of urgency, difficulty urinating, urinary retention and urinary tract infections. These urological problems affect approximately one-third of children with CP, and the prevalence of dysfunctional voiding symptoms such as pollakisuria, incontinence or urinary tract infections is estimated to be more than 30% in the population.

TENS therapy is classified as a neuromodulation therapy. In the last few years, it has been shown in the literature TENS gives positive results in the treatment of urinary symptoms.

Abdominal massage, which is one of the manual therapy techniques; the anterior abdominal wall reduces abdominal muscle tension, increases local circulation, facilitates digestion and stimulates gastric acid secretion, stimulates colonic movements by providing peristaltic stimulation. It is a classical massage method that includes clockwise manual movements over the area where the colon is located. In abdominal massage, by manually applying pressure from the anterior abdominal wall, the digestive organs are compressed between the fingers and the posterior abdominal wall and peristaltic stimulation is created. Hence, stool is pushed from the colon into the rectum. In addition, abdominal massage reduces the severity of constipation symptoms by reducing abdominal bloating and treating trigger points in the abdominal muscles.

This study aim to contribute to the literature by examining the effectiveness of TENS and abdominal massage in the treatment of children with CP with LUTD and comparing the superiority of the two treatment methods to each other.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Besiktas/Istanbul
    • İstanbul, Besiktas/Istanbul, Turkey, 34353
      • Pelin Pişirici

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being between the ages of 5-18
• Diagnosed with Cerebral Palsy
• Having one of the Gross Motor Function Classification System I, II, III and IV grades
• Having a complaint of urinary incontinence

Exclusion Criteria:

• Being younger than 5 years old
• Being level V according to Gross Motor Function Classification System
• Having uncontrolled epileptic seizures
• Anatomical changes in the urinary system
• Having cognitive disability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENS Group; Transcutaneus electric nerve stimulation intervention will be done for a total of 12 weeks, 2 sessions of 20 minutes per week.	Device: TENS; In the study, CE certified tens device with Biolito brand, which is used specifically for incontinence treatment, will be used. The electrodes used during the intervention will be placed to the parasacral region (S2-S4). While the current is given, the power of the device will be gradually increased in 1 mA intervals. The lower value of the stimulation will be 10 mA and the upper value will be 25 mA, and the treatment will be continued with any value that the child can tolerate in this range.
Experimental: Masaj Group; Massage intervention will be done in the form of massage practise to the abdominal region, 2 sessions of 20 minutes per week.	Other: Massage; The massage will be applied to the abdominal area between the subcostal lower border and the anterior superior of the spina iliaca. Massage techniques are as follows: Abdominal patting, colon patting, colon kneading, colon patting again, abdominal patting again. It will be advanced with deep abdominal strokes, then the starting point will be returned with transverse superficial strokes for the transversus abdominis muscle and oblique superficial strokes for the rectus abdominis muscle, and these strokes will be repeated 3 times each, a total of 6 times. Afterwards, 3 times column brushing, 3 times column kneading and 3 times column plastering will be done, respectively. At the end, a total of 6 abdominal strokes will be performed for both the transversus abdominis and oblique abdominal muscles as in the beginning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voiding Disorders Symptom Scoring	Voiding Disorders Symptom Scoring was developed in 2005 and includes 13 questions about symptoms and 1 question about quality of life . The scale is for parents and scoring is done according to the answers from the parents. The total score is between 0-35 points. As the score obtained from the scale increases, the severity of the patient's symptoms also increases.	Change from Baseline at 12th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder Diary	The bladder diary is a simple and non-invasive method of assessing people with lower urinary tract symptoms. The International Children's Continence Society has proposed a chart to assess lower urinary tract dysfunction, showing 48-hour daytime voiding frequency, voiding volume, voiding duration, presence of urgency, type and amount of fluid intake, and degree of urinary incontinence.	Change from Baseline at 12th week
Pediatric Incontinence Quality of Life Scale	Pediatric Incontinence Quality of Life Scale is the first continence quality of life scale developed in the pediatric population. It is a continence-specific quality of life scale developed for children and adolescents in 2006. The Turkish validity and reliability study was performed in 2011. In the initial development stages of the PINQ scale, it was developed as 28 questions including 7 dimensions that evaluate children's social relations with their peers, self-esteem, family and home relations, body image, independence, mental health and treatment. In the following studies, these dimensions were grouped into two as Extrinsic (extrinsic) and Intrinsic (intrinsic), and finally the number of questions was arranged as 20. Each question is given a score of 0 (no), 1 (almost never), 2 (sometimes), 3 (often), 4 (always), and a total score (0-80) is calculated. An increase in the total score indicates that the patient's quality of life worsens .	Change from Baseline at 12th week
Rome IV Criteria	Rome IV criteria allow to detect the presence of constipation in toilet trained or untrained children. Abdominal pain that recurs at least once a week in the last 3 months; If defecation is associated with at least two of the symptoms of a change in the frequency of pooping and a change in the form of poop, constipation is present according to the Rome 4 criteria.	Change from Baseline at 12th week
Bristol Stool Scale	The Bristol Stool Scale (BSS) was developed by Lewis and Heaton at the University of Bristol in 1990 and classifies human faeces into 7 groups. The shape of the stool changes according to the time it stays in the colon. The BSS is a fast and reliable indicator of transit time. There are 7 different poop forms on the Bristol stool scale. Types 3 and 4 correspond to the normal poop form. Types 1 and 2 show that the person has symptoms of constipation. Tip 5,6,7 corresponds to (in order) lack of fiber, mild diarrhea and severe diarrhea.	Change from Baseline at 12th week

Collaborators and Investigators

• Sponsor: Bahçeşehir University
• Collaborators: Tugtepe Pediatric Urology Clinic
• Investigators: Principal Investigator: Betül Ünal, PT, Bahçeşehir University, Graduate Education Institute, Physical Therapy and Rehabilitation; Study Director: Pelin Pişirici, PT, PHD, Bahçeşehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation Department; Study Chair: Halil Tuğtepe, MD, Prof., Private Tuğtepe Pediatric Urology and Surgery Clinic; Study Chair: Aygül Köseoğlu, PT, Msc, Private Tuğtepe Pediatric Urology and Surgery Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Constipation; Voiding disorder; Urinary incontinence; Abdominal massage; Neuromodulation therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Brain Damage, Chronic; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cerebral Palsy; Intestinal Diseases; Urinary Bladder, Neurogenic; Neurogenic Bowel
• Other Study ID Numbers: BBD-TUGTEPE-130422

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No