Sacral Neuromodulation as Treatment for Chronic Constipation

NCT ID: NCT03819062

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-08
• Study Completion Date: 2027-02-01

Brief 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.

Detailed 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.

Conditions

Chronic Constipation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Refractory Constipation with LLLT

Low level laser therapy (LLLT) will be administered to patients with severe refractory chronic constipation

Group Type: EXPERIMENTAL

Low Level Laser Therapy

Intervention Type: DEVICE

A 3 week treatment period with 8 treatment sessions in total.

Interventions

Low Level Laser Therapy

A 3 week treatment period with 8 treatment sessions in total.

Intervention Type: DEVICE

Other Intervention Names

Sacral Neuromodulation; Photobiomodulation

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Jihong Chen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jihong Chen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jihong Chen, MD PhD

Role: CONTACT

chen338@mcmaster.ca

2263439909

Jan D Huizinga, PhD

Role: CONTACT

huizinga@mcmaster.ca

2263438888

Facility Contacts

Jihong Chen, MD PhD

Role: primary

References

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. doi: 10.1080/00365520510012208.

Reference Type: BACKGROUND

PMID: 16036506 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 29226416 (View on PubMed)

Other Identifiers

McMasterChenC

Identifier Type: -

Identifier Source: org_study_id