Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women

Clear Passage Therapies

Status: Terminated

Conditions: FSH Hypersecretion; Infertility; Endocrine System Diseases

Treatments: Other: CPA

Study type: Observational

Funder types: Industry

Identifiers

NCT02027168

FSH-2012-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 1 patient

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1 participants in 1 patient group

CPA treatment

Description:

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

Treatment:

Other: CPA