Reflexology for Chronic Constipation

Phase 2

• Conditions: Chronic Constipation
• Interventions: Procedure: Reflexology

• Registration Number: NCT01599156
• Lead Sponsor: Shaare Zedek Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-06
• Study First Submitted QC: 2012-05-13
• Study First Posted: 2012-05-15
• Status Verified: 2012-07
• Study Start: 2012-07
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-15
• Primary Completion: 2013-04
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reflexology	Reflexology	reflexology treatment, x2-3/week for 12 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel