Sacral Neuromodulation as Treatment for Chronic Constipation

Chronic Constipation Clinical Trial

Official title:

Sacral Neuromodulation as Treatment for Chronic Constipation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03819062
• Other study ID #: McMasterChenC
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2019
• Est. completion date: February 1, 2027

Study information

• Verified date: April 2022
• Source: McMaster University
• Contact: Jihong Chen, MD PhD
• Phone: 2263439909
• Email: chen338[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to study if low level laser therapy will do more good than harm for patients with severe chronic refractory constipation. It is a proof of concept study without a placebo arm.

Description:

Patients will be offered the therapy if High-Resolution Colonic Manometry has shown that coordination between colon motility and recto-anal activity is abnormal and that autonomic nervous system assessment suggests a dysfunction of communication between the spinal cord autonomic nerves and the colon-rectum-anus. The therapy consists of a 3 week treatment with a total of 8 sessions of low level laser therapy. Effects will be assessed using symptom and quality of life questionnaires and physiological assessments of colon and pelvic floor function, at 4 weeks and 12 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with severe chronic refractory constipation

• Must have undergone high resolution colonic manometry that shows abnormal coordination between colonic motility and ano-rectal function.

Exclusion Criteria:

• Pregnant patients

• Known malignancies in the area of treatment

• Active bleeding in area of treatment

• Active deep vein thrombosis

• When tatoos are present at area of treatment

• Patients that are light sensitive

• Patients who take NSAIDS or steroids.

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Device:
• Low Level Laser Therapy
A 3 week treatment period with 8 treatment sessions in total.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. — View Citation

Saito YA, Camilleri M. Editorial: patient assessment of constipation-symptoms (PAC-SYM) questionnaire has a minimal important difference. Aliment Pharmacol Ther. 2018 Jan;47(1):138-139. doi: 10.1111/apt.14389. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of bowel movements/week	(significance level P<0.05 comparing before and after).	12 weeks
Secondary	Change in symptoms using the questionnaire PAC-SYM	The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement, a positive change indicates worsening of symptoms. The minimum important difference indicating clinically significant improvement is minus 0.6 (Saito & Camilleri, 2018)	4 weeks
Secondary	Change in symptoms using the questionnaire PAC-SYM	The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement, a positive change indicates worsening of symptoms. The minimum important difference indicating clinically significant improvement is minus 0.6 (Saito & Camilleri, 2018)	12 weeks
Secondary	Change in quality of life assessed by questionnaire PAC-QOL	The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement, a positive change indicates worsening of symptoms. The minimum difference indicating clinically significant improvement is -0.5 (Marquis et al., 2005)	4 weeks
Secondary	Change in quality of life assessed by questionnaire PAC-QOL	The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement, a positive change indicates worsening of symptoms. The minimum difference indicating clinically significant improvement is -0.5 (Marquis et al., 2005)	12 weeks
Secondary	Autonomic function assessment	Increase or decrease in parasympathetic reactivity in response to a change in body position from supine to standing expressed as Respiratory Sinus Arrhythmia (ln(ms2)); comparison before and after treatment	4 weeks
Secondary	Anal spincter pressure	Anorectal manometry, measuring resting anal sphincter pressure in mmHg; comparison before and after treatment.	4 weeks
Secondary	Change in anal sphincter pressure due to attempting defecation	Anorectal manometry, measuring change in resting anal sphincter pressure in mmHg; comparison before and after treatment	4 weeks