Recruiting

Sacral Neuromodulation

Sponsor:

McMaster University

Code:

NCT03819062

Conditions

Chronic Constipation

Eligibility Criteria

Sex: All

Age: 6 - 70

Healthy Volunteers: Not accepted

Interventions

Low Level Laser Therapy

Study Details

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.

Conditions

Chronic Constipation

Study ID

NCT03819062

Start date

Sep 8, 2019

Status verified date

Apr, 2022

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Refractory Constipation with LLLT

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

Interventions

Low Level Laser Therapy

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

Primary outcome measure

  • Change in number of bowel movements/week [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Jihong Chen, MD PhD

2263439909chen338@mcmaster.ca

Jan D Huizinga, PhD

2263438888huizinga@mcmaster.ca

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8N3Z5

More Information

Sponsor

McMaster University

Last update posted

Apr 5, 2022

Last verified

Apr, 2022

Keywords

  • Constipation
  • spinal cord injury
  • back pain
  • High-Resolution Colonic Manometry
  • Anorectal Manometry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2022-04-05.