An interventional study of Electromyographic Biofeedback (EMG-BF) and Connective Tissue Massage (CTM) in Dyssynergic Defecation, sponsored by Selcuk University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Selcuk University · Not applicable, Interventional, and Treatment
The goal of this randomized controlled clinical trial is to evaluate the effects of connective tissue massage (CTM) added to electromyographic biofeedback (EMG-BF) in adults with dyssynergic defecation (DD). The study will assess bowel function, constipation severity, anal sphincter function, quality of life, and anxiety.
The study will include adults aged 18 years and older who have functional constipation according to the Rome IV criteria and a physician-confirmed diagnosis of DD.
Participants will be randomly assigned to two groups:
Control group: Participants will receive patient education and EMG-BF. Treatment group: Participants will receive the same patient education and EMG-BF, with additional CTM.
Both groups will receive 12 treatment sessions over 6 weeks, with two sessions per week. Patient education will cover pelvic floor muscle anatomy, defecation physiology, diaphragmatic breathing, correct defecation posture and straining, nutrition, fluid intake, and physical activity.
Researchers will assess participants before and after treatment. Assessments will include a 7-day bowel diary, constipation severity, anal sphincter activity measured by surface electromyography, constipation-related quality of life, and anxiety. Researchers will also record participants' physical, demographic, and clinical characteristics.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's planned enrollment of 56 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Selcuk University is the lead sponsor of 255 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Participants will receive patient education covering pelvic floor muscle anatomy, defecation physiology, diaphragmatic breathing, correct defecation posture and straining, nutrition, fluid intake, and physical activity. They will also receive electromyographic biofeedback (EMG-BF). Treatment will be provided twice weekly for 6 weeks, for a total of 12 sessions.
Other: Electromyographic Biofeedback (EMG-BF)
Participants will receive the same patient education and electromyographic biofeedback (EMG-BF) as the control group, with additional connective tissue massage (CTM). Treatment will be provided twice weekly for 6 weeks, for a total of 12 sessions.
Other: Electromyographic Biofeedback (EMG-BF) · Other: Connective Tissue Massage (CTM)
Electromyographic biofeedback (EMG-BF) will be applied using a Neurotrack Myplus Pro 4 device and surface electrodes. Participants will be positioned in the left lateral position. Surface electrodes will be placed around the anus at the 3 and 9 o'clock positions and on the transversus abdominis muscle. A ground electrode will be placed on the arm. Participants will practice pelvic floor and anal sphincter contraction and relaxation, diaphragmatic breathing, and abdominal muscle contraction while maintaining pelvic floor and anal sphincter relaxation. The training will aim to improve coordination among the abdominal muscles, respiratory muscles, pelvic floor, and anal sphincter. Each session will last approximately 20-25 minutes. EMG-BF will be provided twice weekly for 6 weeks, for a total of 12 sessions.
Connective tissue massage (CTM) will be applied to the lumbosacral region, progressing toward the thoracic, scapular, interscapular, and cervico-occipital regions. Before treatment, connective tissue mobility and circulatory responses will be assessed by palpation. Participants will sit upright with their hips, knees, and ankles flexed at 90 degrees. Tissue mobilization will be performed using the palmar surface of the third finger, with the distal interphalangeal joint flexed at 45-60 degrees. Each stroke will be repeated three times. Sessions will last approximately 5-15 minutes, depending on the treated region. CTM will be provided twice weekly for 6 weeks, for a total of 12 sessions, in addition to EMG-BF and patient education.
Anal Sphincter Function
Anal sphincter function will be assessed using surface electromyography during rest, contraction, and straining. The anismus index will also be calculated.
Time frame: Baseline and after 6 weeks of treatment
Constipation Severity
Constipation severity will be assessed using the Constipation Severity Scale. Higher scores indicate greater constipation severity.
Time frame: Baseline and after 6 weeks of treatment
Bowel Function
Bowel function will be assessed using a 7-day bowel diary, including bowel movement frequency, stool type, defecation duration, use of assistance or maneuvers, feeling of complete evacuation, fecal incontinence, medication use, and pain.
Time frame: Baseline and after 6 weeks of treatment
Plan to share: No
Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 18 months after the start.
Of 2,720 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 18 months is above that.
Counting every sponsor, half of 2,789 studies reached it within 12 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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