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

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

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.

Study Overview

• Status: Unknown
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Other: Reflexology

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG7 2UH
    • University of Nottingham Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 34 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 2; No intervention
Experimental: 1; Reflexology	Other: Reflexology; 10 weekly sessions of 45 minutes each

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To identify the most appropriate primary outcome measure for the ensuing RCT	Week 30

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: Dawn-Marie Walker, PhD, University of Nottingham

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): November 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: September 2, 2008
• First Submitted That Met QC Criteria: September 2, 2008
• First Posted (Estimate): September 3, 2008

Study Record Updates

• Last Update Posted (Estimate): December 4, 2012
• Last Update Submitted That Met QC Criteria: December 3, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Polycystic Ovary Syndrome; Reflexology; Complementary and Alternative Medicine; Endocrinopathy; Oligo; Amenorrhoea
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: dmw1