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TerminatedNCT02027168Updated Jan 26, 2015

Effectiveness of Manual Physical Therapy to Improve Endocrine Levels in Women

An observational study in FSH Hypersecretion, Endocrine System Diseases and Infertility, sponsored by Clear Passage Therapies, Inc. Terminated at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-01-26.

Sponsored by Clear Passage Therapies, Inc · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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
02

Conditions studied

  • FSH Hypersecretion
  • Endocrine System Diseases
  • Infertility

Keywords

  • infertility
  • elevated FSH
  • alternative treatment
  • Clear Passage Approach
  • Clear Passage Physical Therapy
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 1 is below the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Clear Passage Therapies, Inc is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women with elevated FSH levels that undergo the CPA treatment

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1 participant (actual)
Patient registry
No

Groups and cohorts

  • CPA treatment

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

    Other: CPA

Interventions

  • OtherCPA

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

    Also known as: Clear Passage Approach, Wurn Technique

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline, pre-treatment and 30 and 60 days post treatment

Secondary outcomes

  1. Pain levels and sexual function before treatment

    Pain levels and sexual function before treatment as compared to baseline.

    Time frame: 30 days before treatment

  2. Pain levels and sexual function post treatment

    Pain levels and sexual function as measured by survey 30 days post treatment compared to baseline.

    Time frame: 30 days post treatment

  3. Pain levels and sexual function post treatment

    Pain levels and sexual function as measured by survey 60 days post treatment compared to baseline.

    Time frame: 60 days post treatment

  4. Pregnancy

    Subjects will be monitored for natural intrauterine pregnancy for the duration of the study.

    Time frame: study duration; 60 days post treatment

07

Study locations

1 site
  • Clear Passage Physical Therapy
    Gainesville, Florida 32606, United States
08

References and documents

Publications

  • 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. PubMed 18251317 ↗
  • 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. PubMed 15775874 ↗
  • 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. PubMed 15266276 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02027168
Lead sponsor
Clear Passage Therapies, Inc
Responsible party
Sponsor
First posted
Jan 6, 2014
Start date
Feb 2013
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Jan 26, 2015

Study contacts

Lawrence J Wurn, LMT
principal investigator · Clear Passage Physical Therapy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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