Chronic Constipation
Conditions
Keywords
Constipation, spinal cord injury, back pain, High-Resolution Colonic Manometry, Anorectal Manometry
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.
Interventions
DEVICELow Level Laser Therapy
A 3 week treatment period with 8 treatment sessions in total.
Sponsors
McMaster University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
proof of concept
Eligibility
Sex/Gender
ALL
Age
6 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of bowel movements/week | 12 weeks | (significance level P\<0.05 comparing before and after). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptoms using the questionnaire PAC-SYM | 4 weeks | 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) |
| Change in quality of life assessed by questionnaire PAC-QOL | 4 weeks | 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) |
| Autonomic function assessment | 4 weeks | 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 |
| Anal spincter pressure | 4 weeks | Anorectal manometry, measuring resting anal sphincter pressure in mmHg; comparison before and after treatment. |
| Change in anal sphincter pressure due to attempting defecation | 4 weeks | Anorectal manometry, measuring change in resting anal sphincter pressure in mmHg; comparison before and after treatment |
Countries
Canada
Contacts
Primary ContactJihong Chen, MD PhD
Backup ContactJan D Huizinga, PhD
Outcome results
None listed