Sacral Neuromodulation as Treatment for Chronic Constipation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-70
SponsorMcMaster University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with severe chronic refractory constipation

Must have undergone high resolution colonic manometry that shows abnormal coordination between colonic motility and ano-rectal function.

Disqualifiers

Pregnant patients

Known malignancies in the area of treatment

Active bleeding in area of treatment

Active deep vein thrombosis

Trial design

Design model

Single group

Treatments tested in this trial

  • Low Level Laser Therapy

    Device

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Refractory Constipation with LLLTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in number of bowel movements/week

(significance level P\<0.05 comparing before and after).

Time frame
12 weeks

Secondary outcomes

1

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)

Time frame
4 weeks
2

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)

Time frame
12 weeks
3

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)

Time frame
4 weeks
4

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)

Time frame
12 weeks

Other outcomes

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