Clinical trial NCT02027168: Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women
Official title: Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: FSH Hypersecretion
Endocrine System Diseases
Infertility
Keywords: infertility
elevated FSH
alternative treatment
Clear Passage Approach
Clear Passage Physical Therapy
Lead sponsor: Clear Passage Therapies, Inc
Sponsor class: INDUSTRY
First posted: 2014-01-06
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with elevated FSH levels that undergo the CPA treatment

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

Eligibility 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.

Primary outcomes:
measure: Change in endocrine levels post treatment
timeFrame: baseline, pre-treatment and 30 and 60 days post treatment
Secondary outcomes:
measure: Pain levels and sexual function before treatment
timeFrame: 30 days before treatment
measure: Pain levels and sexual function post treatment
timeFrame: 30 days post treatment
measure: Pain levels and sexual function post treatment
timeFrame: 60 days post treatment
measure: Pregnancy
timeFrame: study duration; 60 days post treatment
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Clear Passage Physical Therapy
state: Florida
Study officials:
affiliation: Clear Passage Physical Therapy
name: Lawrence J Wurn, LMT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.