Reflexology's Effect on Polycystic Ovary Syndrome (PCOS)

NCT00744510 | Unknown Phase 3

• 1 other identifier: dmw2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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. 1.The menstruation cycle (normal being every 21-35 days).
2. 2.Imbalances in hormone, insulin and blood sugar levels associated with PCOS.
3. 3.Other problems associated with PCOS such as thinning hair on scalp, excessive body hair, and obesity.
4. 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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; Reflexology; Complementary and Alternative Medicine; Endocrinopathy; Oligo; Amenorrhoea

Outcome Measures

Primary Outcomes (1)

• To identify the most appropriate primary outcome measure for the ensuing RCT

  Week 30

Secondary Outcomes (5)

• 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)

Study Arms (2)

1

EXPERIMENTAL

Reflexology

Other: Reflexology

2

NO INTERVENTION

Interventions

Reflexology OTHER

10 weekly sessions of 45 minutes each

1

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with PCOS

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham Hospitals

Nottingham, Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Endocrine System Diseases; Amenorrhea

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Dawn-Marie Walker, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawn-Marie Walker, Phd

CONTACT

+44 (0)115 82 30511; dawn-marie.walker@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: December 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

GB (1)