Reflexology for Chronic Constipation

Study Overview
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Brief Summary
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The purpose of this study is to examine if the use of reflexology can alleviate chronic constipation. The trial will last 26 week per patient, 2 week of screening period, 12 weeks of treatment and 12 weeks of follow up. Included in the study will be 40 men and women, 18 years of age or older, which are able to comply with the study guidelines; Fewer than three spontaneous bowel movement per week; and one or more of the following symptoms/signs during more than 25% of bowel movements for at least 12 weeks within the preceding 12 months: (1) straining, lumpy or (2) hard stools, and (3) a sensation of incomplete evacuation. Exclusion criteria are: Loose or watery stool in the absence of laxative use for more than 25% of bowel movements during the 12 weeks preceding the trials; Mushy stool defined as a score of 6 on the Bristol Stool Form Scale for any SBM during the baseline period; Rome III criteria for the irritable bowel syndrome; History of pelvic-floor dysfunction; Neurological pathologies; Psychiatric conditions; Chronic use of medication with a gastro intestinal-activity.

Official Title
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Reflexology for Patients Suffering From Chronic Constipation- a Phase II B, Single Armed, Open Label Study.

Conditions
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Chronic Constipation

Intervention / Treatment
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* Procedure: Reflexology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18-55 years Fewer than three SBMs per week (occurring without the use of a laxative, enema, or suppository within the preceding 24 hours) One or more of the following symptoms/signs during more than 25% of bowel movements for at least 12 weeks within the preceding 12 months:(1)straining, lumpy or (2) hard stools, and (3)a sensation of incomplete evacuation Six or fewer SBMs/week and fewer than three complete CSBMs/week during the 14-day baseline period. Ability to comply with the study guidelines Exclusion Criteria: Loose or watery stool in the absence of laxative use for more than 25% of bowel movements during the 12 weeks preceding the trials. Mushy stool defined as a score of 6 on the Bristol Stool Form Scale for any SBM during the baseline period. Rome III criteria for the irritable bowel syndrome. History of pelvic-floor dysfunction. Neurological pathologies Psychiatric conditions Chronic use of medication with a GI-activity.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reflexology<br>reflexology treatment, x2-3/week for 12 weeks | Procedure: Reflexology<br>* Reflexology is a therapy whereby diagnosis and treatment are done on the patient's feet. According to reflexology, our feet are a micro-cosmos of our bodies and contain all the body's systems and internal organs. The treatment is palpation and massage of specific reflex points that respond to the body organs. This massage or palpitation of reflex points improves the physical function of the corresponding organ or system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in complete spontaneous bowel movements (CSBM)/week from baseline to 24 weeks | Will be assessed daily during the 24 weeks of the study | 24 weeks | 
| Increase of at least one CSBM per week from baseline for 9 or more weeks during the 24-week treatment period | Will be assessed weekly during the 24 weeks of the study | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool frequency/Week (CSBMs and spontaneous bowel movements (SBMs) | Will be assessed weekly during the 24 weeks of the study | 24 weeks | 
| Stool consistency/week using the 7- point Bristol Stool Form Scale, during the 24 weeks of the study period | Will be assessed weekly during the 24 weeks of the study | 24 weeks | 
| Severity of straining using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount). | Will be assessed daily during the 24 weeks of the study | 24 weeks | 
| Abdominal discomfort, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount) | Will be assessed daily during the 24 weeks of the study | 24 weeks | 
| Severity of bloating, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount) | Will be assessed daily during the 24 weeks of the study | 24 weeks | 
| Constipation severity (using a 5-point ordinal scale, with higher scores indicating greater severity) | Will be assessed weekly during the 24 weeks of the study | 24 weeks | 
| Constipation relief (based on a 7-point balanced scale, with 1 indicating complete relief, 4 indicating no change, and 7 indicating very severe constipation) | Will be assessed weekly during the 24 weeks of the study | 24 weeks | 
| Satisfaction with the trial results, using a 5-point ordinal scale | will be assessed at the 12-week visit and at the 24-week visit (at the study end) | 24 weeks | 
| Health related quality of life (using the validated Patient Assessment of Constipation Quality of Life instrument (PAC-QOL) | will be assessed at baseline; at the 12-week visit and at the 24-week visit (at the study end) | 24 weeks | 
| Treatment side effects | Will be assessed at baseline, week 12 and week 24 (trial end) | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic constipation, Reflexology, Complementary medicine