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Reflexology's Effect on Polycystic Ovary Syndrome (PCOS) (REPOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00744510
Recruitment Status : Unknown
Verified December 2012 by University of Nottingham.
Recruitment status was:  Not yet recruiting
First Posted : September 1, 2008
Last Update Posted : December 4, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Other: Reflexology Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reflexology's Effect on Polycystic Ovary Syndrome (REPOS): A Pilot Study
Study Start Date : December 2012
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Other: Reflexology
10 weekly sessions of 45 minutes each

No Intervention: 2

Primary Outcome Measures :
  1. To identify the most appropriate primary outcome measure for the ensuing RCT [ Time Frame: Week 30 ]

Secondary Outcome Measures :
  1. Attainment of normal menstrual cycle length (i.e. 21-35 days) [ Time Frame: 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ]
  2. Hormonal imbalances and irregular menses (commonly regarded at 6 cycles per annum or less) [ Time Frame: 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ]
  3. Weight, body mass index (BMI), hirsutism, thinning hair [ Time Frame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ]
  4. Fasting Insulin and blood sugar levels [ Time Frame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ]
  5. Quality of Life [ Time Frame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00744510

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Contact: Dawn-Marie Walker, Phd +44 (0)115 82 30511

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United Kingdom
University of Nottingham Hospitals
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
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Principal Investigator: Dawn-Marie Walker, PhD University of Nottingham
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Responsible Party: University of Nottingham Identifier: NCT00744510    
Other Study ID Numbers: dmw2
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: December 2012
Keywords provided by University of Nottingham:
Polycystic Ovary Syndrome
Complementary and Alternative Medicine
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases