Reflexology's Effect on Polycystic Ovary Syndrome: A Pilo... | NCT00746148

Studies
Reflexology's Effect on Polycystic Ovary Syndrome: A Pilot Study

NCT00746148

Sponsor

University of Nottingham

Status

Unknown status

Last Update Posted

Dec 4, 2012Estimated

Enrollment

140Estimated

Phase

Phase 3

Conditions

Polycystic Ovary Syndrome

Interventions

Reflexology

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Nov 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Sep 2, 2008

First Submission Date that Met QC Criteria

Sep 2, 2008

First Posted Date

Sep 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2012

Last Update Posted Date

Dec 4, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Reflexology	Other: Reflexology
2	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reflexology	Other	10 weekly sessions of 45 minutes each	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dawn-Marie Walker, Phd	Contact	+44 (0)115 82 30511		dawn-marie.walker@nottingham.ac.uk

Overall Officials

Name	Affiliation	Role
Dawn-Marie Walker, PhD	University of Nottingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Nottingham Hospitals		Nottingham	Nottingham	NG7 2UH	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome
D004700	Endocrine System Diseases
D000568	Amenorrhea

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026201	Musculoskeletal Manipulations

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided