Reflexology for Chronic Constipation

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Constipation
• Intervention / Treatment: Procedure: Reflexology

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
    • Contact: Menachem Oberbaum, MD; Phone Number: +972-2-6666395; Email: oberbaum@szmc.org.il
    • Principal Investigator: Menachem Oberbaum, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Reflexology; reflexology treatment, x2-3/week for 12 weeks

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Principal Investigator: Menachem Oberbaum, MD, Menachem Oberbaum, MD, Phone:+972-2-6666395, Email: oberbaum@szmc.org.il; Principal Investigator: Joseph Lysy, Joseph Lysy,Phone: +972-2-6666116 Email: lysyj@szmc.org.il

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): April 1, 2013

Study Registration Dates

• First Submitted: May 6, 2012
• First Submitted That Met QC Criteria: May 13, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Estimate): January 15, 2013
• Last Update Submitted That Met QC Criteria: January 14, 2013
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Reflexology; Complementary medicine; Chronic constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: REF11