Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation

NCT07890727 | Recruiting

• 1 other identifier: 2025/1305
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Dyssynergic Defecation

Keywords

Dyssynergic Defecation; Electromyographic Biofeedback; Connective Tissue Massage; Functional Constipation; Constipation-Related Quality of Life; Anxiety

Outcome Measures

Primary Outcomes (1)

• Anal Sphincter Function

  Anal sphincter function will be assessed using surface electromyography during rest, contraction, and straining. The anismus index will also be calculated.

  Baseline and after 6 weeks of treatment

Secondary Outcomes (1)

• Constipation Severity

  Baseline and after 6 weeks of treatment

Other Outcomes (1)

• Bowel Function

  Baseline and after 6 weeks of treatment

Study Arms (2)

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.

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.

Other: Electromyographic Biofeedback (EMG-BF); Other: Connective Tissue Massage (CTM)

Interventions

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.

Control Group: EMG-BF and Patient Education; Treatment Group: EMG-BF and CTM

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.

Treatment Group: EMG-BF and CTM

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years and older.
• Individuals with functional constipation according to the Rome IV criteria.
• Individuals diagnosed with dyssynergic defecation by a physician.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Özel Sağlık Meslek Hizmet Birimi Fizyoterapist Beyza Nur Pınarcık

Konya, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• 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.

  PMID: 31487902 BACKGROUND

• Patcharatrakul 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.

  PMID: 29111136 BACKGROUND

• Orhan 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.

  PMID: 32893023 BACKGROUND

• Orhan 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.

  PMID: 27793072 BACKGROUND

• Nikjooy 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.

  PMID: 36128319 BACKGROUND

• Lee 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.

  PMID: 25807997 BACKGROUND

• Gursen 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.

  PMID: 26099205 BACKGROUND

• Ahadi 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.

  PMID: 25538778 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

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: Dr.

Study Record Dates

• First Submitted: October 16, 2026
• First Posted: October 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: October 22, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)