Reflexology's Effect on Polycystic Ovary Syndrome: A Pilot Study

Polycystic Ovary Syndrome Clinical Trial

— REPOS  

Official title:

Reflexology's Effect on Polycystic Ovary Syndrome (REPOS): A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00746148
• Other study ID #: dmw1
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 2, 2008
• Last updated: December 3, 2012
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2012
• Source: University of Nottingham
• Contact: Dawn-Marie Walker, Phd
• Phone: +44 (0)115 82 30511
• Email: dawn-marie.walker[@]nottingham.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Polycystic Ovary Syndrome (PCOS) is very common, affecting approximately 5% of women of reproductive age, and impacts not only on quality of life, but also has long-term health consequences for many sufferers, such as increased risks of developing Type II diabetes, cardiovascular disease and cancer of the womb. The symptoms that may occur such as irregular periods; lots of body hair; thinning hair on scalp, obesity and infertility, can also lead to poor self-esteem. Whilst treatments can help fertility, other treatments to correct the other symptoms are less successful. Alternative methods to regulate periods would be helpful, especially ones which avoid the long-term use of steroids in patients who may already be overweight. Reflexology is poorly represented in scientific papers, with nothing published regarding reflexology and its effect upon PCOS. However patients who use reflexology report more regular periods, thicker hair on scalp and greater wellbeing. Therefore we aim to investigate the effect of reflexology on:

1. The menstruation cycle (normal being every 21-35 days).

2. Imbalances in hormone, insulin and blood sugar levels associated with PCOS.

3. Other problems associated with PCOS such as thinning hair on scalp, excessive body hair, and obesity.

4. Quality of life. Government and NHS agendas agree that if there's evidence of an effective complimentary therapy the NHS should provide it. Therefore the results may have an influence on the care pathways of patients with PCOS towards a more holistic, patient centred and empowered approach. It is also non invasive and liable to result in higher patient satisfaction regarding their treatment. This research may also inform policy makers so that complementary medicine provision is provided on a wider basis within the NHS, which at the moment is dictated by the individual Trust's budget allocation. However this research could save money overall as in America, the yearly cost of treating PCOS is $4.36 billion.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

Inclusion Criteria:

• Women with PCOS

Exclusion Criteria:

• use of complimentary therapies within 6/12 prior to recruitment

• BMI >35

• taken combined oral contraceptives, metformin, or cyclical progestogens within 3/12 prior to recruitment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• Reflexology
10 weekly sessions of 45 minutes each

Locations

Country	Name	City	State
United Kingdom	University of Nottingham Hospitals	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify the most appropriate primary outcome measure for the ensuing RCT		Week 30	No
Secondary	Attainment of normal menstrual cycle length (i.e. 21-35 days)		1 (baseline), week 10 (end of treatment) and week 30 (end of study)	No
Secondary	Hormonal imbalances and irregular menses (commonly regarded at 6 cycles per annum or less)		1 (baseline), week 10 (end of treatment) and week 30 (end of study)	No
Secondary	weight, body mass index (BMI), hirsutism, thinning hair		week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)	No
Secondary	Fasting Insulin and blood sugar levels		week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)	No
Secondary	Quality of Life		week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)	No