Electromyographic Biofeedback Therapy in Patients With Dyssynergic Defecation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Game-Based Electromyographic (EMG) Biofeedback Therapy, Sham Control.
- Who it may be relevant to
- Registry conditions: Defecation Disorder. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Game-Based Electromyographic Biofeedback Therapy on Quality of Life and Sleep Quality in Patients With Dyssynergic Defecation
Overview
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.
Detailed description
This study aimed to investigate the effects of game-based electromyographic (EMG) biofeedback therapy on quality of life, sleep quality, constipation severity, and pelvic floor muscle function in individuals diagnosed with dyssynergic defecation and chronic constipation. Dyssynergic defecation is a common functional defecation disorder and is one of the leading causes of chronic constipation. It is characterized by paradoxical contraction or inadequate relaxation of the pelvic floor muscles and anal sphincters during defecation, resulting in impaired evacuation of the rectum. This condition leads to excessive straining, a sensation of incomplete evacuation, prolonged stool retention, and significant deterioration in quality of life. Epidemiological studies indicate that dyssynergic defecation accounts for a substantial proportion of chronic constipation cases referred to tertiary care centers for treatment. In patients with dyssynergic defecation, pharmacological treatments alone are often insufficient because they do not address the underlying neuromuscular coordination disorder. Therefore, contemporary management strategies emphasize behavioral and rehabilitative interventions aimed at retraining pelvic floor muscle coordination in women with UI. Among these approaches, EMG biofeedback therapy has emerged as one of the most effective and evidence-based treatment modalities for this condition. Previous randomized controlled trials have demonstrated that EMG biofeedback improves defecation dynamics, reduces constipation-related symptoms, and provides sustained benefits compared with conventional treatment. Despite its proven efficacy, conventional EMG biofeedback therapy may be limited by reduced patient motivation, difficulty in understanding abstract muscle activity patterns, and decreased adherence. In recent years, game-based biofeedback systems have been introduced to overcome these limitations by enhancing patient engagement and facilitating the motor learning process. 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 in patients. Another important but often overlooked consequence of chronic constipation and dyssynergic defecation is the impaired sleep quality. Persistent abdominal discomfort, bloating, and defecation-related anxiety can negatively affect sleep patterns, leading to fatigue, reduced daytime functioning, and further deterioration in quality of life (QoL). However, limited data are available on the effects of pelvic floor rehabilitation and biofeedback therapy on sleep quality in this patient population. In recent years, increasing attention has been given to the role of objective physiological assessments in evaluating the efficacy of treatments. Anorectal manometry provides quantitative information on anorectal motility and pelvic floor muscle coordination and is considered the gold standard for diagnosing of dyssynergic defecation. The inclusion of objective manometric measurements alongside patient-reported outcomes allows for a comprehensive evaluation of both the clinical and physiological responses to treatment. Therefore, this randomized controlled study aimed to evaluate the short- and mid-term effects of game-based EMG biofeedback therapy, applied in addition to standard pelvic floor rehabilitation, compared with sham EMG biofeedback in individuals with dyssynergic defecation. The primary outcome of this study was the change in quality of life, assessed using the Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaire. Secondary outcomes included sleep quality, constipation severity, defecation patterns, pain intensity, pelvic floor muscle function assessed using surface EMG, and anorectal motility evaluated using anal manometry. By combining subjective clinical scales with objective physiological measurements, this study aimed to provide high-quality evidence regarding the effectiveness of adaptive, game-based EMG biofeedback therapy in the management of dyssynergic defecation. The findings are expected to contribute to the development of patient-centered, motivation-enhancing rehabilitation strategies and support the integration of game-based biofeedback approaches into standard pelvic floor rehabilitation programs.
Interventions
- Device Game-Based Electromyographic (EMG) Biofeedback Therapy
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. - Device Sham Control
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.
Primary outcome measures
- Patient Assessment of Constipation-Quality of Life Questionnaire [Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.]
Secondary outcome measures (5)
- Pittsburgh Sleep Quality Index [Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.]
- Constipation Severity Instrument [Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.]
- Bristol Stool Scale [Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.]
- Visual Analog Scale [Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.]
- Anorectal manometry [Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Kocaeli University — Kocaeli
Publications
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07482696 · 2024-KAEK-02.bI.04