Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women

This study is currently recruiting participants.
Verified January 2014 by Clear Passage Therapies, Inc
Sponsor:
Information provided by (Responsible Party):
Clear Passage Therapies, Inc
ClinicalTrials.gov Identifier:
NCT02027168
First received: January 2, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention
FSH Hypersecretion
Endocrine System Diseases
Infertility
Other: CPA

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women

Resource links provided by NLM:


Further study details as provided by Clear Passage Therapies, Inc:

Primary Outcome Measures:
  • Change in endocrine levels post treatment [ Time Frame: baseline, pre-treatment and 30 and 60 days post treatment ] [ Designated as safety issue: No ]
    Change in FSH, LH and estradiol levels from baseline and pre-treatment, baseline and 30 and 60 day post treatment.


Secondary Outcome Measures:
  • Pain levels and sexual function before treatment [ Time Frame: 30 days before treatment ] [ Designated as safety issue: No ]
    Pain levels and sexual function before treatment as compared to baseline.

  • Pain levels and sexual function post treatment [ Time Frame: 30 days post treatment ] [ Designated as safety issue: No ]
    Pain levels and sexual function as measured by survey 30 days post treatment compared to baseline.

  • Pain levels and sexual function post treatment [ Time Frame: 60 days post treatment ] [ Designated as safety issue: No ]
    Pain levels and sexual function as measured by survey 60 days post treatment compared to baseline.

  • Pregnancy [ Time Frame: study duration; 60 days post treatment ] [ Designated as safety issue: No ]
    Subjects will be monitored for natural intrauterine pregnancy for the duration of the study.


Estimated Enrollment: 67
Study Start Date: February 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with elevated FSH levels that undergo the CPA treatment

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02027168

Locations
United States, Florida
Clear Passage Physical Therapy Recruiting
Gainesville, Florida, United States, 32606
Contact: Amanda Rice, Ph.D.    352-336-1433    research@clearpassage.com   
Principal Investigator: Lawrence J Wurn, LMT         
Sponsors and Collaborators
Clear Passage Therapies, Inc
Investigators
Principal Investigator: Lawrence J Wurn, LMT Clear Passage Physical Therapy
  More Information

Additional Information:
Publications:
Responsible Party: Clear Passage Therapies, Inc
ClinicalTrials.gov Identifier: NCT02027168     History of Changes
Other Study ID Numbers: FSH-2012-001
Study First Received: January 2, 2014
Last Updated: January 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Clear Passage Therapies, Inc:
infertility
elevated FSH
alternative treatment
Clear Passage Approach
Clear Passage Physical Therapy

Additional relevant MeSH terms:
Endocrine System Diseases
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014