Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women

January 22, 2015 updated by: Clear Passage Therapies, Inc
This study will examine the impact of manual physical therapy on endocrine function in women diagnosed as being infertile due to elevated follicle stimulating hormone (FSH) levels (10 mIU/mL or higher) on days 2-5 of their menstrual cycle. It is hypothesized that the manual physical therapy will decrease FSH levels.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study will investigate the effect of manual physical therapy on the endocrine levels of women by comparison of pre- and post- treatment hormone levels (FSH, LH and Estradiol). Secondary measures include assessment of pain and sexual function via questionnaires.

Hormones will be measured at prescribed time points:

  • baseline: 30-60 days before treatment
  • pre-treatment: 7-30 days before treatment
  • post treatment 1: 10-30 days post treatment
  • post treatment 2: 30-60 days post treatment

Pain and sexual function questionnaires will be completed:

  • baseline: 30-60 days before treatment
  • pre-treatment: 7-30 days before treatment
  • post treatment 1: 30 days post treatment
  • post treatment 2: 60 days post treatment

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32606
        • Clear Passage Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with elevated FSH levels that undergo the CPA treatment

Description

Inclusion Criteria:

  • Diagnosed as infertile
  • FSH greater than 10mIU/mL on days 2-5 of menstrual cycle
  • Regular menstrual cycle
  • Residing in the US, accessible to a LabCorp testing facility

Exclusion Criteria:

  • Active infection including HIV or inflammation
  • Cancer within the past 5 years
  • Currently pregnant
  • Hemophilia, abnormal bleeding or clotting disorder
  • Immune system disorder
  • Abnormal ovarian cyst or endometrioma
  • BMI of 35 or greater
  • Any other condition in which deep manual physical therapy is contraindicated
  • Currently taking any fertility medications or planning to take any fertility related medications during the course of the study. This includes all ovarian stimulating medications, artificial hormones and birth control medications.
  • Participation in any assisted reproductive technique (such as IVF) other than intra-uterine insemination during the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CPA treatment
CPA treatment group receives 20 hours of patient centered manual physical therapy
Other: CPA
Site specific, patient centered manual physical therapy regimen focused on restoring function to the entire body
Other Names:
  • Clear Passage Approach
  • Wurn Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in endocrine levels post treatment
Time Frame: baseline, pre-treatment and 30 and 60 days post treatment
Change in FSH, LH and estradiol levels from baseline and pre-treatment, baseline and 30 and 60 day post treatment.
baseline, pre-treatment and 30 and 60 days post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain levels and sexual function before treatment
Time Frame: 30 days before treatment
Pain levels and sexual function before treatment as compared to baseline.
30 days before treatment
Pain levels and sexual function post treatment
Time Frame: 30 days post treatment
Pain levels and sexual function as measured by survey 30 days post treatment compared to baseline.
30 days post treatment
Pain levels and sexual function post treatment
Time Frame: 60 days post treatment
Pain levels and sexual function as measured by survey 60 days post treatment compared to baseline.
60 days post treatment
Pregnancy
Time Frame: study duration; 60 days post treatment
Subjects will be monitored for natural intrauterine pregnancy for the duration of the study.
study duration; 60 days post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clear Passage Therapies, Inc

Investigators

  • Principal Investigator: Lawrence J Wurn, LMT, Clear Passage Physical Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

January 2, 2014

First Posted (ESTIMATE)

January 6, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSH-2012-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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