Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women

Terminated

• Conditions: Endocrine System Diseases; Infertility; FSH Hypersecretion
• Interventions: Other: CPA

• Registration Number: NCT02027168
• Lead Sponsor: Clear Passage Therapies, Inc

Brief Summary

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.

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-02
• Study First Posted: 2014-01-06
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-22
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CPA treatment	CPA	CPA treatment group receives 20 hours of patient centered manual physical therapy

Primary Outcome Measures

Name	Time	Method
Change in endocrine levels post treatment	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clear Passage Physical Therapy; 🇺🇸 Gainesville, Florida, United States