Reflexology for Chronic Constipation

Chronic Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01599156
• Other study ID #: REF11
• Status: Recruiting
• Phase: Phase 2
• First received: May 6, 2012
• Last updated: January 14, 2013
• Start date: July 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2012
• Source: Shaare Zedek Medical Center
• Contact: Menachem Oberbaum, MD
• Phone: +972-2-6666395
• Email: oberbaum[@]szmc.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Procedure:
• Reflexology
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

Locations

Country	Name	City	State
Israel	The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Stool frequency/Week (CSBMs and spontaneous bowel movements (SBMs)	Will be assessed weekly during the 24 weeks of the study	24 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Treatment side effects	Will be assessed at baseline, week 12 and week 24 (trial end)	24 weeks	No