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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by University of Nottingham
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT00746148
First received: September 2, 2008
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Polycystic Ovary Syndrome
Other: Reflexology
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reflexology's Effect on Polycystic Ovary Syndrome (REPOS): A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • To identify the most appropriate primary outcome measure for the ensuing RCT [ Time Frame: Week 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • weight, body mass index (BMI), hirsutism, thinning hair [ Time Frame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ] [ Designated as safety issue: No ]
  • Fasting Insulin and blood sugar levels [ Time Frame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Reflexology
Other: Reflexology
10 weekly sessions of 45 minutes each
No Intervention: 2
No intervention

  Eligibility

Ages Eligible for Study:   20 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746148

Contacts
Contact: Dawn-Marie Walker, Phd +44 (0)115 82 30511 dawn-marie.walker@nottingham.ac.uk

Locations
United Kingdom
University of Nottingham Hospitals Not yet recruiting
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Dawn-Marie Walker, PhD University of Nottingham
  More Information

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT00746148     History of Changes
Other Study ID Numbers: dmw1
Study First Received: September 2, 2008
Last Updated: December 3, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
Polycystic Ovary Syndrome
Reflexology
Complementary and Alternative Medicine
Endocrinopathy
Oligo
Amenorrhoea

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014