- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07705984
Kinesio Taping for Neurogenic Bowel Dysfunction in Spinal Cord Injury
Effectiveness of Kinesio Taping on Neurogenic Bowel Dysfunction in Individuals With Spinal Cord Injury: A Randomized Controlled Trial
Neurogenic bowel dysfunction is a common complication of spinal cord injury and may cause constipation, difficulty with defecation, prolonged bowel care, incomplete evacuation, fecal incontinence, and reduced quality of life. This randomized controlled trial aims to evaluate the effectiveness of Kinesio Taping added to a routine bowel management program in adults with spinal cord injury and upper motor neuron-type neurogenic bowel dysfunction.
Thirty participants will be randomly assigned to one of two parallel groups. The control group will receive a routine bowel management program, while the intervention group will receive Kinesio Taping in addition to the routine bowel management program. Kinesio Taping will be applied to the lower abdominal and lumbosacral regions three times per week for 4 weeks.
The primary outcome will be defecation frequency recorded using a 7-day bowel diary. Secondary outcomes will include stool consistency, defecation duration, perceived constipation severity, neurogenic bowel dysfunction severity, and health-related quality of life. Assessments will be performed before and after the 4-week intervention.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Meltem Gunes Akıncı, MD
- Numéro de téléphone: +902582966000
- E-mail: meltem_aytekin@hotmail.com
Lieux d'étude
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Denizli
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Denizli, Denizli, Turquie (Türkiye), 20160
- Pamukkale University Hospital
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Contact:
- Meltem Gunes Akıncı, MD
- Numéro de téléphone: +902586000
- E-mail: meltem_aytekin@hotmail.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adults aged 18 years or older with traumatic or nontraumatic spinal cord injury
- Neurological level of injury at T12 or above
- Upper motor neuron-type neurogenic bowel dysfunction
- Duration of spinal cord injury longer than 6 months
- Ability and willingness to provide written informed consent
Exclusion Criteria:
- Age younger than 18 years
- Neurological level of injury below T12
- Gastrointestinal disease diagnosed before the spinal cord injury, including irritable bowel syndrome or inflammatory bowel disease
- History of conservative treatment for neurogenic bowel dysfunction within the previous 6 months
- Colostomy or history of bowel surgery
- Neurological disease other than spinal cord injury that may cause gastrointestinal or anal sphincter dysfunction
- Cognitive impairment that may interfere with participation in the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Routine Bowel Management Program
Participants in this arm will receive an individualized routine bowel management program based on their clinical condition for 4 weeks.
The program may include scheduled bowel care, dietary and fluid recommendations, appropriate positioning, physical activity, abdominal massage, rectal evacuation techniques, suppositories, enemas, and oral or rectal laxatives when clinically indicated.
Participants will be instructed not to change their usual dietary habits during the study period.
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Participants will receive an individualized routine bowel management program based on their clinical condition for 4 weeks.
The program may include scheduled bowel care, dietary and fluid recommendations, appropriate positioning, physical activity, abdominal massage, rectal evacuation techniques, suppositories, enemas, and oral or rectal laxatives when clinically indicated.
Participants will be instructed not to change their usual dietary habits during the study period.
|
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Expérimental: Kinesio Taping Plus Routine Bowel Management Program
Participants in this arm will receive Kinesio Taping in addition to the routine bowel management program for 4 weeks.
Kinesio Taping will be applied to the lower abdominal and lumbosacral regions three times per week by the same experienced physician.
The tape will remain in place for 2 days and will be removed before the next treatment session.
A star-shaped correction technique will be applied to the lumbosacral region with 25%-50% tension, and an I-shaped correction technique will be applied to the lower abdominal region between the right and left anterior superior iliac spines.
No tension will be applied to the ends of the tape
|
Participants will receive an individualized routine bowel management program based on their clinical condition for 4 weeks.
The program may include scheduled bowel care, dietary and fluid recommendations, appropriate positioning, physical activity, abdominal massage, rectal evacuation techniques, suppositories, enemas, and oral or rectal laxatives when clinically indicated.
Participants will be instructed not to change their usual dietary habits during the study period.
Kinesio Taping will be applied to the lower abdominal and lumbosacral regions three times per week for 4 weeks.
The tape will remain in place for 2 days and will be removed before the next treatment session.
A star-shaped correction technique will be applied to the lumbosacral region with 25%-50% tension.
An I-shaped correction technique will be applied to the lower abdominal region between the right and left anterior superior iliac spines.
No tension will be applied to the ends of the tape.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Defecation Frequency
Délai: Baseline and at the end of the 4-week intervention
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Defecation frequency will be recorded using a 7-day bowel diary and expressed as the total number of defecations during a 7-day period.
Higher values indicate more frequent bowel movements.
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Baseline and at the end of the 4-week intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Bristol Stool Form Scale Score
Délai: Baseline and at the end of the 4-week intervention
|
Stool consistency will be assessed using the 7-point Bristol Stool Form Scale.
Type 1 indicates separate hard lumps, while Type 7 indicates entirely liquid stool.
Types 3 to 5 generally represent softer or more desirable stool consistency.
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Baseline and at the end of the 4-week intervention
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Change in Perceived Constipation Severity
Délai: Baseline and at the end of the 4-week intervention
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Participants will rate the overall severity of constipation on a 10-cm Visual Analog Scale ranging from 0 to 10.
A score of 0 indicates no constipation, while a score of 10 indicates very severe constipation.
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Baseline and at the end of the 4-week intervention
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Change in Neurogenic Bowel Dysfunction Score
Délai: Baseline and at the end of the 4-week intervention
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Neurogenic bowel dysfunction severity will be assessed using the 10-item Neurogenic Bowel Dysfunction Score.
The total score ranges from 0 to 47, with higher scores indicating more severe neurogenic bowel dysfunction.
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Baseline and at the end of the 4-week intervention
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Change in Short Form-36 Health Survey Scores
Délai: Baseline and at the end of the 4-week intervention
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Health-related quality of life will be assessed using the 36-item Short Form Health Survey.
The instrument includes eight subscales, each scored from 0 to 100.
Higher scores indicate better perceived health status.
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Baseline and at the end of the 4-week intervention
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Change in Defecation Duration
Délai: Baseline and at the end of the 4-week intervention
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Defecation duration will be recorded in minutes using a 7-day bowel diary.
Participants will record the time required to complete each bowel evacuation.
A shorter duration indicates less time spent on bowel care.
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Baseline and at the end of the 4-week intervention
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Change in the Feeling of Complete Evacuation
Délai: Baseline and at the end of the 4-week intervention
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The feeling of complete bowel evacuation will be recorded in the 7-day bowel diary after each defecation.
The outcome will be expressed as the number or proportion of defecations associated with a feeling of complete evacuation during the 7-day assessment period.
Higher values indicate more frequent complete evacuation.
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Baseline and at the end of the 4-week intervention
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Change in Straining During Defecation
Délai: Baseline and at the end of the 4-week intervention
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Straining during defecation will be recorded in the 7-day bowel diary.
The outcome will be expressed as the number or proportion of defecations accompanied by straining during the 7-day assessment period.
Lower values indicate less frequent straining.
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Baseline and at the end of the 4-week intervention
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Change in Painful Defecation
Délai: Baseline and at the end of the 4-week intervention
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Painful defecation will be recorded in the 7-day bowel diary.
The outcome will be expressed as the number or proportion of defecations associated with pain during the 7-day assessment period.
Lower values indicate less frequent painful defecation.
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Baseline and at the end of the 4-week intervention
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Dandinoglu T, Kaya E. Kinesio Taping in spinal cord injury rehabilitation: A scoping review. J Spinal Cord Med. 2026 Feb 12:1-9. doi: 10.1080/10790268.2026.2626116. Online ahead of print.
- Karaaslan Y, Karakus A, Koc DO, Bayrakli A, Celenay ST. Effectiveness of Abdominal Massage Versus Kinesio Taping in Women With Chronic Constipation: A Randomized Controlled Trial. J Neurogastroenterol Motil. 2024 Oct 30;30(4):501-511. doi: 10.5056/jnm23131. Epub 2024 Jun 3.
- Orhan C, Kaya Kara O, Kaya S, Akbayrak T, Kerem Gunel M, Baltaci G. The effects of connective tissue manipulation and Kinesio Taping on chronic constipation in children with cerebral palsy: a randomized controlled trial. Disabil Rehabil. 2018 Jan;40(1):10-20. doi: 10.1080/09638288.2016.1236412. Epub 2016 Oct 28.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux central
- Maladies du système nerveux
- Blessures et Blessures
- Signes et symptômes digestifs
- Maladies intestinales
- Maladies du système digestif
- Maladies gastro-intestinales
- Maladies du côlon
- Maladies du côlon, fonctionnelles
- Traumatisme, système nerveux
- Maladies de la moelle épinière
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Constipation
- Blessures à la moelle épinière
- Intestin neurogène
Autres numéros d'identification d'étude
- E-60116787-020-887485
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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