Polycystic Ovary SyndromePhase 3REPOSNCT00746148
Reflexology's Effect on Polycystic Ovary Syndrome: A Pilot Study
A Phase 3 study testing Reflexology in people with Polycystic Ovary Syndrome, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2012to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with PCOS
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham Hospitals
Nottingham, Nottingham, NG7 2UH
About this study
Official title: 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:
- 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Reflexology
- Keywords
- Polycystic Ovary Syndrome, Reflexology, Complementary and Alternative Medicine, Endocrinopathy, Oligo, Amenorrhoea
- Medical subject headings
- Polycystic Ovary Syndrome, Endocrine System Diseases, Amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyOther
10 weekly sessions of 45 minutes each
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Reflexology Receives: Other: Reflexology |
| 2 | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the most appropriate primary outcome measure for the ensuing RCT
Measured: Week 30
Secondary outcomes (5)
Attainment of normal menstrual cycle length (i.e. 21-35 days)
Measured: 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)
Measured: 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
weight, body mass index (BMI), hirsutism, thinning hair
Measured: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
Fasting Insulin and blood sugar levels
Measured: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
Quality of Life
Measured: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startDec 2012
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dawn-Marie Walker, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746148
- Sponsor's protocol ID
- dmw1
- Acronym
- REPOS
- Status last verified
- Dec 2012
- First submitted
- 2 Sep 2008
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reflexology's Effect on Polycystic Ovary Syndrome (REPOS): A Pilot Study
- ClinicalTrials.gov ID
- NCT00746148
- Acronym / sponsor ID
- REPOS / dmw1
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, Reflexology, Complementary and Alternative Medicine, Endocrinopathy, Oligo, Amenorrhoea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: ReflexologyReflexology |
| 2 | No intervention | –No intervention |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with PCOS
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reflexology10 weekly sessions of 45 minutes each | Other | 1 |
Primary outcome
To identify the most appropriate primary outcome measure for the ensuing RCT
Time frame: Week 30
5 secondary outcomes
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)
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)
weight, body mass index (BMI), hirsutism, thinning hair
Time frame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
Fasting Insulin and blood sugar levels
Time frame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
Quality of Life
Time frame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn-Marie Walker, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reflexology in people with Polycystic Ovary Syndrome, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dawn-Marie Walker, Phd (+44 (0)115 82 30511, dawn-marie.walker@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the most appropriate primary outcome measure for the ensuing RCT (time frame: Week 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.