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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refractory Constipation with LLLT | Experimental | Low level laser therapy (LLLT) will be administered to patients with severe refractory chronic constipation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Level Laser Therapy | Device | A 3 week treatment period with 8 treatment sessions in total. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of bowel movements/week | (significance level P<0.05 comparing before and after). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihong Chen, MD PhD | Contact | 2263439909 | chen338@mcmaster.ca | |
| Jan D Huizinga, PhD | Contact | 2263438888 | huizinga@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jihong Chen, MD PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Recruiting | Hamilton | Ontario | L8N3Z5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16036506 | Background | 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. | |
| 29226416 | Background | 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. |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D013119 | Spinal Cord Injuries |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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proof of concept
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| 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) | 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) | 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) | 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 | 4 weeks |
| Anal spincter pressure | Anorectal manometry, measuring resting anal sphincter pressure in mmHg; comparison before and after treatment. | 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 | 4 weeks |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |