Electromyographic Biofeedback Therapy in Patients With Dyssynergic Defecation

NCT07482696 | Not Yet Recruiting DMC

• 1 other identifier: 2024-KAEK-02.bI.04
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate the effects of game-based electromyographic (EMG) biofeedback therapy on the quality of life and sleep quality of individuals diagnosed with dyssynergic defecation.

Conditions

Defecation Disorder

Keywords

Dyssynergic Defecation; Electromyographic Biofeedback; Pelvic Floor Rehabilitation; Constipation

Outcome Measures

Primary Outcomes (1)

• Patient Assessment of Constipation-Quality of Life Questionnaire

  The Patient Assessment of Constipation-Quality of Life questionnaire is a validated and reliable patient-reported outcome measure developed to assess the impact of chronic constipation on the quality of life. The scale consists of 28 items grouped into four subdomains. * Physical Discomfort: Assesses constipation-related physical symptoms and bodily discomfort. * Psychosocial Discomfort: Evaluates the impact of the condition on emotional status, social functioning, and psychological well-being. * Worries and Concerns: Assesses anxiety, concerns, and illness-related perceptions associated with constipation. * Satisfaction: Evaluates patients' satisfaction with their current bowel function and treatments. Each item is scored on a 5-point Likert scale, with higher scores indicating a greater negative impact on the quality of life.

  At baseline, immediately after the intervention, and 2-months after the intervention.

Secondary Outcomes (5)

• Pittsburgh Sleep Quality Index

  At baseline, immediately after the intervention, and 2-months after the intervention.

• Constipation Severity Instrument

  At baseline, immediately after the intervention, and 2-months after the intervention.

• Bristol Stool Scale

  At baseline, immediately after the intervention, and 2-months after the intervention.

• Visual Analog Scale

  At baseline, immediately after the intervention, and 2-months after the intervention.

• Anorectal manometry

  At baseline, immediately after the intervention, and 2-months after the intervention.

Study Arms (2)

Biofeedback Group

EXPERIMENTAL

Participants in the experimental group will receive game-based electromyographic (EMG) biofeedback therapy in addition to the standard pelvic floor rehabilitation program.

Device: Game-Based Electromyographic (EMG) Biofeedback Therapy

Control Group

SHAM COMPARATOR

Participants in the control group will receive sham EMG biofeedback therapy alongside the same standard pelvic floor rehabilitation program with identical session frequency and duration.

Device: Sham Control

Interventions

Game-Based Electromyographic (EMG) Biofeedback Therapy DEVICE

Game-based biofeedback integrates real-time visual feedback with interactive tasks, allowing patients to actively control on-screen elements through appropriate muscle activation and relaxation. This approach supports motor learning principles, promotes neuromuscular adaptation, and may improve treatment compliance.

Biofeedback Group

Sham Control DEVICE

Sham EMG biofeedback therapy will be administered alongside the same standard pelvic floor rehabilitation program with identical session frequency and duration. Surface electrodes will be placed in the same anatomical locations; however, the biofeedback device will operate in demo mode, and visual feedback will not reflect actual muscle activity.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of dyssynergic defecation was confirmed by anorectal manometry, which demonstrated paradoxical pelvic floor muscle contraction and/or inadequate relaxation during defecation.
• Eligibility for a pelvic floor rehabilitation program was based on a comprehensive evaluation conducted at the Physical Medicine and Rehabilitation Clinic.
• Age between 18 and 70 years.
• A history of chronic constipation lasting at least six months, in accordance with the Rome IV diagnostic criteria.
• Stool consistency was classified as type 1 or type 2 according to the Bristol Stool Scale, indicating a hard stool pattern.

You may not qualify if:

• Presence of communication barriers that may interfere with participation in the study.
• Cognitive impairment affects the ability to comply with rehabilitation programs or assessments.
• Pregnancy.
• Presence of severe depression and/or anxiety disorder.
• Untreated metabolic or endocrine disorders, including but not limited to diabetes mellitus, hypothyroidism, hypokalemia, and hypercalcemia.
• Use of medications known to cause or exacerbate constipation.
• History of spinal, rectal, or pelvic surgery, excluding cholecystectomy, hysterectomy, and appendectomy.
• Presence of colorectal malignancy or inflammatory bowel disease.
• Anorectal malformations or congenital pelvic floor anomalies.
• Spina bifida, spinal cord injury, or neurological disorders, including multiple sclerosis, Parkinson's disease, dementia, or epilepsy.
• Presence of severe cardiac or renal disease.
• Advanced-stage hemorrhoids, anal fissures, or anal fistulas.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, Izmit, Turkey (Türkiye)

Location

Related Publications (12)

• Simon MA, Bueno AM. Efficacy of Biofeedback Therapy in the Treatment of Dyssynergic Defecation in Community-Dwelling Elderly Women. J Clin Gastroenterol. 2017 Nov/Dec;51(10):e90-e94. doi: 10.1097/MCG.0000000000000794.

  PMID: 28059942 BACKGROUND

• Chiarioni G, Whitehead WE, Pezza V, Morelli A, Bassotti G. Biofeedback is superior to laxatives for normal transit constipation due to pelvic floor dyssynergia. Gastroenterology. 2006 Mar;130(3):657-64. doi: 10.1053/j.gastro.2005.11.014.

  PMID: 16530506 BACKGROUND

• Yamamoto S, Kawamura Y, Yamamoto K, Yamaguchi Y, Tamura Y, Izawa S, Nakagawa H, Wakita Y, Hijikata Y, Ebi M, Funaki Y, Ohashi W, Ogasawara N, Sasaki M, Maekawa M, Kasugai K. Internet Survey of Japanese Patients With Chronic Constipation: Focus on Correlations Between Sleep Quality, Symptom Severity, and Quality of Life. J Neurogastroenterol Motil. 2021 Oct 30;27(4):602-611. doi: 10.5056/jnm20135.

  PMID: 34642281 BACKGROUND

• Sahin M, Dogan I, Cengiz M, Unal S. The impact of anorectal biofeedback therapy on the quality of life of patients with dyssynergic defecation. Turk J Gastroenterol. 2015 Mar;26(2):140-4. doi: 10.5152/tjg.2015.4689.

  PMID: 25835112 BACKGROUND

• Sadeghi A, Akbarpour E, Majidirad F, Bor S, Forootan M, Hadian MR, Adibi P. Dyssynergic Defecation: A Comprehensive Review on Diagnosis and Management. Turk J Gastroenterol. 2023 Mar;34(3):182-195. doi: 10.5152/tjg.2023.22148.

  PMID: 36919830 BACKGROUND

• Ozkutuk N, Eser I, Bor S. Effectiveness of Biofeedback Therapy on Quality of Life in Patients with Dyssynergic Defecation Disorder. Turk J Gastroenterol. 2021 Jan;32(1):22-29. doi: 10.5152/tjg.2020.19678.

  PMID: 33893763 BACKGROUND

• Heymen S, Scarlett Y, Jones K, Ringel Y, Drossman D, Whitehead WE. Randomized, controlled trial shows biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia-type constipation. Dis Colon Rectum. 2007 Apr;50(4):428-41. doi: 10.1007/s10350-006-0814-9.

  PMID: 17294322 BACKGROUND

• Rao SS, Valestin J, Brown CK, Zimmerman B, Schulze K. Long-term efficacy of biofeedback therapy for dyssynergic defecation: randomized controlled trial. Am J Gastroenterol. 2010 Apr;105(4):890-6. doi: 10.1038/ajg.2010.53. Epub 2010 Feb 23.

  PMID: 20179692 BACKGROUND

• Schrader R, Maschuw R. [Reduction of the surface dose of Co 60 rays in a tissue depth of 0 to 3 mm by means of a magnetic field (author's transl)]. Strahlentherapie. 1980 Apr;156(4):257-63. German.

  PMID: 7368232 BACKGROUND

• Rao SS, Patcharatrakul T. Diagnosis and Treatment of Dyssynergic Defecation. J Neurogastroenterol Motil. 2016 Jul 30;22(3):423-35. doi: 10.5056/jnm16060.

  PMID: 27270989 BACKGROUND

• Xu Y, Li X, Xia F, Xu F, Chen JDZ. Efficacy of a Modified Training Program of Adaptive Biofeedback Therapy for Dyssynergic Defecation in Patients with Chronic Constipation. Dig Dis Sci. 2022 Apr;67(4):1320-1327. doi: 10.1007/s10620-021-07094-z. Epub 2021 Jun 15.

  PMID: 34129127 BACKGROUND

• Rao SS, Seaton K, Miller M, Brown K, Nygaard I, Stumbo P, Zimmerman B, Schulze K. Randomized controlled trial of biofeedback, sham feedback, and standard therapy for dyssynergic defecation. Clin Gastroenterol Hepatol. 2007 Mar;5(3):331-8. doi: 10.1016/j.cgh.2006.12.023.

  PMID: 17368232 RESULT

MeSH Terms

Conditions

Constipation

Interventions

Electromyography; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Central Study Contacts

Tugba Gokbel, Assistant Prof, MD

CONTACT

+905442877390; tugbagokbelftr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Prof. Dr.

Model Details: Game-based electromyographic (EMG) biofeedback therapy

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 19, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)