Clinical trial NCT01599156: Reflexology for Chronic Constipation
Official title: Reflexology for Patients Suffering From Chronic Constipation- a Phase II B, Single Armed, Open Label Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Constipation
Keywords: Chronic constipation
Reflexology
Complementary medicine
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in complete spontaneous bowel movements (CSBM)/week from baseline to 24 weeks
timeFrame: 24 weeks
measure: Increase of at least one CSBM per week from baseline for 9 or more weeks during the 24-week treatment period
timeFrame: 24 weeks
Secondary outcomes:
measure: Stool frequency/Week (CSBMs and spontaneous bowel movements (SBMs)
timeFrame: 24 weeks
measure: Stool consistency/week using the 7- point Bristol Stool Form Scale, during the 24 weeks of the study period
timeFrame: 24 weeks
measure: Severity of straining using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount).
timeFrame: 24 weeks
measure: Abdominal discomfort, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount)
timeFrame: 24 weeks
measure: Severity of bloating, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount)
timeFrame: 24 weeks
measure: Constipation severity (using a 5-point ordinal scale, with higher scores indicating greater severity)
timeFrame: 24 weeks
measure: Constipation relief (based on a 7-point balanced scale, with 1 indicating complete relief, 4 indicating no change, and 7 indicating very severe constipation)
timeFrame: 24 weeks
measure: Satisfaction with the trial results, using a 5-point ordinal scale
timeFrame: 24 weeks
measure: Health related quality of life (using the validated Patient Assessment of Constipation Quality of Life instrument (PAC-QOL)
timeFrame: 24 weeks
measure: Treatment side effects
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
Study officials:
affiliation: Menachem Oberbaum, MD, Phone:+972-2-6666395, Email: oberbaum@szmc.org.il
name: Menachem Oberbaum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Joseph Lysy,Phone: +972-2-6666116 Email: lysyj@szmc.org.il
name: Joseph Lysy
role: PRINCIPAL_INVESTIGATOR
References: