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

NCT ID: NCT05351138

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2023-11-01

Brief Summary

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.

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.

Conditions

Bladder Dysfunction; Bowel Dysfunction; Cerebral Palsy; Neurogenic Bladder; Neurogenic Bowel

Study Design

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

Study Groups

TENS Group

Transcutaneus electric nerve stimulation intervention will be done for a total of 12 weeks, 2 sessions of 20 minutes per week.

Group Type: EXPERIMENTAL

TENS

Intervention Type: DEVICE

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.

Masaj Group

Massage intervention will be done in the form of massage practise to the abdominal region, 2 sessions of 20 minutes per week.

Group Type: EXPERIMENTAL

Massage

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tugtepe Pediatric Urology Clinic

OTHER

Sponsor Role: collaborator

Bahçeşehir University

OTHER

Sponsor Role: lead

Responsible Party

Pelin Pişirici

Assistant Professor, PT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Betül Ünal, PT

Role: PRINCIPAL_INVESTIGATOR

Bahçeşehir University, Graduate Education Institute, Physical Therapy and Rehabilitation

Pelin Pişirici, PT, PHD

Role: STUDY_DIRECTOR

Bahçeşehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation Department

Halil Tuğtepe, MD, Prof.

Role: STUDY_CHAIR

Private Tuğtepe Pediatric Urology and Surgery Clinic

Aygül Köseoğlu, PT, Msc

Role: STUDY_CHAIR

Private Tuğtepe Pediatric Urology and Surgery Clinic

Locations

Pelin Pişirici

Istanbul, Besiktas/Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BBD-TUGTEPE-130422

Identifier Type: -

Identifier Source: org_study_id