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
- Are there results?
- Not yet: the study is under way
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.The scale consists of 16 items divided into three subscales: Obstructive Defecation, Colonic Inertia, and Pain. The maximum scores for the Obstructive Defecation, Colonic Inertia, and Pain subscales are 28, 29, and 16, respectively. The total score ranges from 0 to 73, with higher scores indicating 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.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- 26 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Connective Tissue Massage Applied in Addition to Biofeedback Therapy in Individuals With Dyssynergic Defecation
- ClinicalTrials.gov ID
- NCT07890727
- Acronym / sponsor ID
- 2025/1305
- Conditions
- Dyssynergic Defecation
- Keywords
- Dyssynergic Defecation, Electromyographic Biofeedback, Connective Tissue Massage, Functional Constipation, Constipation-Related Quality of Life, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: EMG-BF and Patient Education | Active comparator | Other: Electromyographic Biofeedback (EMG-BF)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. |
| Treatment Group: EMG-BF and CTM | Experimental | Other: Electromyographic Biofeedback (EMG-BF), Other: Connective Tissue Massage (CTM)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years and older.
- Individuals with functional constipation according to the Rome IV criteria.
- Individuals diagnosed with dyssynergic defecation by a physician.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromyographic Biofeedback (EMG-BF)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. | Other | Control Group: EMG-BF and Patient Education, Treatment Group: EMG-BF and CTM |
| Connective Tissue Massage (CTM)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. | Other | Treatment Group: EMG-BF and CTM |
Primary outcome
Anal Sphincter Function
Time frame: Baseline and after 6 weeks of treatment
Anal sphincter function will be assessed using surface electromyography during rest, contraction, and straining. The anismus index will also be calculated.
1 secondary outcome
Constipation Severity
Time frame: Baseline and after 6 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 31487902Simon 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.
- Background: PubMed 29111136Patcharatrakul 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.
- Background: PubMed 32893023Orhan 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.
- Background: PubMed 27793072Orhan 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.
- Background: PubMed 36128319Nikjooy 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.
- Background: PubMed 25807997Lee 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.
- Background: PubMed 26099205Gursen 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.
- Background: PubMed 25538778Ahadi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Özel Sağlık Meslek Hizmet Birimi Fizyoterapist Beyza Nur Pınarcık
Konya, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anal Sphincter Function (time frame: Baseline and after 6 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07890727, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.