Chronic ConstipationNCT03819062
Sacral Neuromodulation as Treatment for Chronic Constipation
A study testing Low Level Laser Therapy in people with Chronic Constipation, run by McMaster University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- Low Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 8 Sep 2019to 1 Feb 2027
- 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 6 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with severe chronic refractory constipation
- Must have undergone high resolution colonic manometry that shows abnormal coordination between colonic motility and ano-rectal function.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario, L8N3Z5
Jihong Chen, MD PhD
About this study
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.
Read the 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
- Being tested
- Low Level Laser Therapy
- Keywords
- Constipation, spinal cord injury, back pain, High-Resolution Colonic Manometry, Anorectal Manometry
- Medical subject headings
- Constipation, Spinal Cord Injuries, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
Also called Sacral Neuromodulation, Photobiomodulation
A 3 week treatment period with 8 treatment sessions in total.
| Study group | Role | What they receive |
|---|---|---|
| Refractory Constipation with LLLT | Experimental | Low level laser therapy (LLLT) will be administered to patients with severe refractory chronic constipation Receives: Device: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of bowel movements/week
(significance level P<0.05 comparing before and after).
Measured: 12 weeks
Secondary outcomes (7)
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)
Measured: 4 weeks
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)
Measured: 12 weeks
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)
Measured: 4 weeks
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)
Measured: 12 weeks
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
Measured: 4 weeks
Anal spincter pressure
Anorectal manometry, measuring resting anal sphincter pressure in mmHg; comparison before and after treatment.
Measured: 4 weeks
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start8 Sep 2019
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic ConstipationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- proof of concept
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihong Chen, McMaster University
- Investigators
- Jihong Chen, MD PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819062
- Sponsor's protocol ID
- McMasterChenC
- Status last verified
- Apr 2022
- First submitted
- 16 Jan 2019
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16036506Saito 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.
PubMed 29226416
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacral Neuromodulation as Treatment for Chronic Constipation
- ClinicalTrials.gov ID
- NCT03819062
- Acronym / sponsor ID
- McMasterChenC
- Conditions
- Chronic Constipation
- Keywords
- Constipation, spinal cord injury, back pain, High-Resolution Colonic Manometry, Anorectal Manometry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 8 Sep 2019 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 28 Jan 2019 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- proof of concept
| Arm | Type | Receives |
|---|---|---|
| Refractory Constipation with LLLT | Experimental | Device: Low Level Laser TherapyLow level laser therapy (LLLT) will be administered to patients with severe refractory chronic constipation |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with severe chronic refractory constipation
- Must have undergone high resolution colonic manometry that shows abnormal coordination between colonic motility and ano-rectal function.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Low Level Laser TherapyAlso: Sacral Neuromodulation, PhotobiomodulationA 3 week treatment period with 8 treatment sessions in total. | Device | Refractory Constipation with LLLT |
Primary outcome
Change in number of bowel movements/week
Time frame: 12 weeks
(significance level P<0.05 comparing before and after).
7 secondary outcomes
Change in symptoms using the questionnaire PAC-SYM
Time frame: 4 weeks
Change in symptoms using the questionnaire PAC-SYM
Time frame: 12 weeks
Change in quality of life assessed by questionnaire PAC-QOL
Time frame: 4 weeks
Change in quality of life assessed by questionnaire PAC-QOL
Time frame: 12 weeks
Autonomic function assessment
Time frame: 4 weeks
Anal spincter pressure
Time frame: 4 weeks
Change in anal sphincter pressure due to attempting defecation
Time frame: 4 weeks
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 5 Apr 2022.
- Background: PubMed 16036506Marquis 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.
- Background: PubMed 29226416Saito 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.
- Individual participant dataSharing planned: Undecided
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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.
Jihong Chen, MD PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy in people with Chronic Constipation, run by McMaster University at 1 site in Canada.
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 2 inclusion and 7 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 5 Apr 2022. 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 Canada. 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?
Contact Jihong Chen, MD PhD (2263439909, chen338@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of bowel movements/week (time frame: 12 weeks). 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 NCT03819062, which also lists 2 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 5 Apr 2022.