Reflexology's Effect on Polycystic Ovary Syndrome (PCOS)

Phase 3

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: Reflexology

• Registration Number: NCT00744510
• Lead Sponsor: University of Nottingham

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-29
• Study First Submitted QC: 2008-08-29
• Study First Posted: 2008-09-01
• Status Verified: 2012-12
• Study Start: 2012-12
• Last Update Submitted: 2012-12-03
• Last Update Posted: 2012-12-04
• Primary Completion: 2013-03
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Reflexology	Reflexology

Primary Outcome Measures

Name	Time	Method
To identify the most appropriate primary outcome measure for the ensuing RCT	Week 30

Secondary Outcome Measures

Name	Time	Method
Attainment of normal menstrual cycle length (i.e. 21-35 days)	1 (baseline), week 10 (end of treatment) and week 30 (end of study)
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)
Weight, body mass index (BMI), hirsutism, thinning hair	week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
Fasting Insulin and blood sugar levels	week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
Quality of Life	week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)

Trial Locations

Locations (1)

University of Nottingham Hospitals; 🇬🇧 Nottingham, United Kingdom