Dyssynergic DefecationNCT07890727
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
A study testing Electromyographic Biofeedback (EMG-BF) and Connective Tissue Massage (CTM) in people with Dyssynergic Defecation, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyssynergic Defecation
- What is being tested?
- Electromyographic Biofeedback (EMG-BF) and Connective Tissue Massage (CTM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older.
- Individuals with functional constipation according to the Rome IV criteria.
- Individuals diagnosed with dyssynergic defecation by a physician.
Who cannot join
- Individuals with systemic, neurological, or metabolic diseases.
- Individuals who are pregnant.
- Individuals with abdominal hernias or coexisting colonic diseases.
- Individuals with a history of colorectal, gastrointestinal, spinal, or pelvic surgery.
- Individuals with open wounds or tumors in the areas where massage will be applied.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Özel Sağlık Meslek Hizmet Birimi Fizyoterapist Beyza Nur Pınarcık
Konya
Beyza N PINARCIK, Master's degree, 506-790-8701, beyzanurpinarcik@gmail.com
Beyza Nur PINARCIK, master's degree
About this study
Official title: Effects of Connective Tissue Massage Applied in Addition to Biofeedback Therapy in Individuals With Dyssynergic Defecation
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.
Read more
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.
- Conditions
- Dyssynergic Defecation
- Being tested
- Electromyographic Biofeedback (EMG-BF), Connective Tissue Massage (CTM)
- Keywords
- Dyssynergic Defecation, Electromyographic Biofeedback, Connective Tissue Massage, Functional Constipation, Constipation-Related Quality of Life, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyographic Biofeedback (EMG-BF)Other
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: EMG-BF and Patient Education | Active comparator | 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. Receives: Other: Electromyographic Biofeedback (EMG-BF) |
| Treatment Group: EMG-BF and CTM | Experimental | 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. Receives: Other: Electromyographic Biofeedback (EMG-BF); Other: Connective Tissue Massage (CTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anal Sphincter Function
Anal sphincter function will be assessed using surface electromyography during rest, contraction, and straining. The anismus index will also be calculated.
Measured: Baseline and after 6 weeks of treatment
Secondary outcomes (1)
Constipation Severity
Constipation severity will be assessed using the Constipation Severity Scale. Higher scores indicate greater constipation severity.
Measured: Baseline and after 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Jun 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dyssynergic DefecationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra KORKUT, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890727
- Sponsor's protocol ID
- 2025/1305
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simon MA, Bueno AM, Otero P, Vazquez FL, Blanco V. A Randomized Controlled Trial on the Effects of Electromyographic Biofeedback on Quality of Life and Bowel Symptoms in Elderly Women With Dyssynergic Defecation. Int J Environ Res Public Health. 2019 Sep 4;16(18):3247. doi: 10.3390/ijerph16183247.
PubMed 31487902Patcharatrakul T, Valestin J, Schmeltz A, Schulze K, Rao SSC. Factors Associated With Response to Biofeedback Therapy for Dyssynergic Defecation. Clin Gastroenterol Hepatol. 2018 May;16(5):715-721. doi: 10.1016/j.cgh.2017.10.027. Epub 2017 Oct 27.
PubMed 29111136Orhan C, Ozgul S, Baran E, Uzelpasaci E, Akbayrak T. Comparison of Connective Tissue Manipulation and Abdominal Massage Combined With Usual Care vs Usual Care Alone for Chronic Constipation: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2020 Oct;43(8):768-778. doi: 10.1016/j.jmpt.2019.05.013. Epub 2020 Sep 3.
PubMed 32893023Orhan 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.
PubMed 27793072Nikjooy A, Khoshlahjeh Sedgh A, Mahjoubi B, Mirzaei R, Naziri M, Mirbehresi P. The Effects of Cognitive Behavioral Therapy with Biofeedback Therapy on the Quality of Life, Anxiety, Depression and Somatic Symptoms in Patients with Dyssynergic Defecation: A Randomized Controlled Trial. Med J Islam Repub Iran. 2022 Jul 5;36:74. doi: 10.47176/mjiri.36.74. eCollection 2022.
PubMed 36128319Lee HJ, Boo SJ, Jung KW, Han S, Seo SY, Koo HS, Yoon IJ, Park SH, Yang DH, Kim KJ, Ye BD, Byeon JS, Yang SK, Kim JH, Myung SJ. Long-term efficacy of biofeedback therapy in patients with dyssynergic defecation: results of a median 44 months follow-up. Neurogastroenterol Motil. 2015 Jun;27(6):787-95. doi: 10.1111/nmo.12552. Epub 2015 Mar 25.
PubMed 25807997Gursen C, Kerem Gunel M, Kaya S, Kav T, Akbayrak T. Effect of Connective Tissue Manipulation on Symptoms and Quality of Life in Patients With Chronic Constipation: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2015 Jun;38(5):335-43. doi: 10.1016/j.jmpt.2015.06.003. Epub 2015 Jun 20.
PubMed 26099205Ahadi T, Madjlesi F, Mahjoubi B, Mirzaei R, Forogh B, Daliri SS, Derakhshandeh SM, Behbahani RB, Raissi GR. The effect of biofeedback therapy on dyssynergic constipation in patients with or without Irritable Bowel Syndrome. J Res Med Sci. 2014 Oct;19(10):950-5.
PubMed 25538778