Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women

Infertility Clinical Trial

Official title:

Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02027168
• Other study ID #: FSH-2012-001
• Status: Terminated
• Phase: N/A
• First received: January 2, 2014
• Last updated: January 22, 2015
• Start date: February 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Clear Passage Therapies, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endocrine System Diseases
• FSH Hypersecretion
• Infertility

Intervention

Other:
• CPA
Site specific, patient centered manual physical therapy regimen focused on restoring function to the entire body

Locations

Country	Name	City	State
United States	Clear Passage Physical Therapy	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Clear Passage Therapies, Inc

Country where clinical trial is conducted

United States, 

References & Publications (3)

Wurn BF, Wurn LJ, King CR, Heuer MA, Roscow AS, Hornberger K, Scharf ES. Treating fallopian tube occlusion with a manual pelvic physical therapy. Altern Ther Health Med. 2008 Jan-Feb;14(1):18-23. — View Citation

Wurn BF, Wurn LJ, King CR, Heuer MA, Roscow AS, Scharf ES, Shuster JJ. Treating female infertility and improving IVF pregnancy rates with a manual physical therapy technique. MedGenMed. 2004 Jun 18;6(2):51. Review. — View Citation

Wurn LJ, Wurn BF, King CR, Roscow AS, Scharf ES, Shuster JJ. Increasing orgasm and decreasing dyspareunia by a manual physical therapy technique. MedGenMed. 2004 Dec 14;6(4):47. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in endocrine levels 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	No
Secondary	Pain levels and sexual function before treatment	Pain levels and sexual function before treatment as compared to baseline.	30 days before treatment	No
Secondary	Pain levels and sexual function post treatment	Pain levels and sexual function as measured by survey 30 days post treatment compared to baseline.	30 days post treatment	No
Secondary	Pain levels and sexual function post treatment	Pain levels and sexual function as measured by survey 60 days post treatment compared to baseline.	60 days post treatment	No
Secondary	Pregnancy	Subjects will be monitored for natural intrauterine pregnancy for the duration of the study.	study duration; 60 days post treatment	No

External Links

•   Related Info
•   Study Website