EndometriosisEndo2017NCT03118154
Efficacy of Manual Therapy to Improve Quality of Life and Decrease Pain in Subjects With Endometriosis
An observational study of Endometriosis and Pelvic Pain, run by Clear Passage Therapies, Inc at 1 site in United States.
Trial summary
This study will compare subjects with a history of pelvic or menstrual pain diagnosed with endometriosis treated at Clear Passage with untreated control subjects. The treatment group will be a retrospective chart review; the control subject group will be a prospective questionnaire based study. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Pelvic Pain, Dysmenorrhea
- What is being tested?
- Manual Physical Therapy
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2017to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study focuses on female subjects with a medical diagnosis of endometriosis that experience pain with menstruation or pelvic pain not associated with menstruation between the ages of 18 and 65.
Who may be able to join
- Diagnosis of endometriosis
- Experience either pain with menstruation or other pelvic pain
- Able to complete the questionnaires online
Who cannot join
- Currently pregnant
- Cancer diagnosis
- Prior chemotherapy or radiation treatment(s)
- Prior treatment at Clear Passage
Trial locations and contacts
1 site in 1 country.
United States1 site
Clear Passage Physical Therapy
Gainesville, Florida, 32606
About this study
This study will compare subjects with a history of pelvic or menstrual pain diagnosed with endometriosis treated at Clear Passage with untreated control subjects. The treatment group will be a retrospective chart review; the control subject group will be a prospective questionnaire based study.
The study will assess the changes in pain experienced by subjects treated with manual therapy at Clear Passage to untreated subjects with endometriosis.
Read the detailed description
This study has two segments the first is a chart and outcome assessment of patients treated at Clear Passage (CP) with a diagnosis of endometriosis. These patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. The second segment is a prospective observational, online questionnaire based study of female subjects with a diagnosis of endometriosis not treated at CP. Data on the impact of quality of life (QOL) over time of subjects not treated at CP will be assessed using the same questionnaire used as standard of care in the clinic twice, 30 days apart. This will be accomplished using online forms with subjects able to complete the questionnaires with ease via the internet. The data obtained from the untreated subjects will allow for reporting of overall impact on QOL in this population, as well as provide a control group for assessment of improvement for manual therapy interventions for patients with endometriosis.
- Conditions
- Endometriosis, Pelvic Pain, Dysmenorrhea
- Being tested
- Manual Physical Therapy
- Keywords
- endometriosis, pelvic pain, dysmenorrhea
- Medical subject headings
- Endometriosis, Pelvic Pain, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Physical TherapyOther
Manual Physical Therapy intervention using the Clear Passage Approach (CPA). The focus of the CPA is to deform adhesions throughout the body using a variety of manual therapy techniques and modalities.
| Study group | Role | What they receive |
|---|---|---|
| Manual Physical Therapy, retrospective | Endometriosis subjects treated at Clear Passage with follow up to assess changes in pain and overall health in a retrospective chart review. Receives: Other: Manual Physical Therapy | |
| Control, prospective | Endometriosis control subjects not treated at Clear Passage that complete two questionnaires, 30 days apart, to assess changes in their pain levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported overall pain rating
Self reported values using the Pain Questionnaire
Measured: 30 days
Reported Global Health
Self reported values using the Global Health Questionnaire
Measured: 30 days
Reported Pain Intensity
Self reported values using the Pain Interference Questionnaire
Measured: 30 days
Reported Sexual Function
Self reported values using the Female Sexual Function Index Questionnaire
Measured: 30 days
Secondary outcomes (1)
Correlations to positive treatment outcomes
Medical history correlations for positive outcomes in subjects treated with manual therapy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start31 Mar 2017
- Primary completion1 Oct 2017 (estimated)
- Study completion31 Mar 2018 (estimated)
Why it stopped: Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clear Passage Therapies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawrence J Wurn, LMT, Principal investigator, Clear Passage Therapies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118154
- Sponsor's protocol ID
- ENDO-2017-C0100
- Acronym
- Endo2017
- Status last verified
- Sep 2017
- First submitted
- 5 Apr 2017
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rice AD, Patterson K, Wurn BF, King CR and Wurn LJ. Update on "Decreasing dyspareunia and dysmenorrhea in women with endometriosis via a manual physical therapy: results from 2 independent studies". Journal of Endometriosis and Pelvic Pain Disorders, 6(3):161-162, 2014.
Wurn BF, Wurn LJ, Patterson K, King CR, Scharf ES. Decreasing dyspareunia and dysmenorrhea in women with endometriosis via a manual physical therapy: Results from two independent studies. Journal of Endometriosis and Pelvic Pain Disorders 3(4):188-196, 2011.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Manual Therapy to Improve Quality of Life and Decrease Pain in Subjects With Endometriosis
- ClinicalTrials.gov ID
- NCT03118154
- Acronym / sponsor ID
- Endo2017 / ENDO-2017-C0100
- Conditions
- Endometriosis, Pelvic Pain, Dysmenorrhea
- Keywords
- endometriosis, pelvic pain, dysmenorrhea
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Clear Passage Therapies, IncIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 1 Oct 2017 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare subjects with a history of pelvic or menstrual pain diagnosed with endometriosis treated at Clear Passage with untreated control subjects. The treatment group will be a retrospective chart review; the control subject group will be a prospective questionnaire based study.
The study will assess the changes in pain experienced by subjects treated with manual therapy at Clear Passage to untreated subjects with endometriosis.
Detailed description
This study has two segments the first is a chart and outcome assessment of patients treated at Clear Passage (CP) with a diagnosis of endometriosis. These patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. The second segment is a prospective observational, online questionnaire based study of female subjects with a diagnosis of endometriosis not treated at CP. Data on the impact of quality of life (QOL) over time of subjects not treated at CP will be assessed using the same questionnaire used as standard of care in the clinic twice, 30 days apart. This will be accomplished using online forms with subjects able to complete the questionnaires with ease via the internet. The data obtained from the untreated subjects will allow for reporting of overall impact on QOL in this population, as well as provide a control group for assessment of improvement for manual therapy interventions for patients with endometriosis.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Physical Therapy, retrospective | – | Other: Manual Physical TherapyEndometriosis subjects treated at Clear Passage with follow up to assess changes in pain and overall health in a retrospective chart review. |
| Control, prospective | – | –Endometriosis control subjects not treated at Clear Passage that complete two questionnaires, 30 days apart, to assess changes in their pain levels. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study focuses on female subjects with a medical diagnosis of endometriosis that experience pain with menstruation or pelvic pain not associated with menstruation between the ages of 18 and 65.
Key inclusion criteria (3 listed)
- Diagnosis of endometriosis
- Experience either pain with menstruation or other pelvic pain
- Able to complete the questionnaires online
Key exclusion criteria (4 listed)
- Currently pregnant
- Cancer diagnosis
- Prior chemotherapy or radiation treatment(s)
- Prior treatment at Clear Passage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Physical TherapyManual Physical Therapy intervention using the Clear Passage Approach (CPA). The focus of the CPA is to deform adhesions throughout the body using a variety of manual therapy techniques and modalities. | Other | Manual Physical Therapy, retrospective |
Primary outcome
Reported overall pain rating
Time frame: 30 days
Self reported values using the Pain Questionnaire
Reported Global Health
Time frame: 30 days
Self reported values using the Global Health Questionnaire
Reported Pain Intensity
Time frame: 30 days
Self reported values using the Pain Interference Questionnaire
Reported Sexual Function
Time frame: 30 days
Self reported values using the Female Sexual Function Index Questionnaire
1 secondary outcome
Correlations to positive treatment outcomes
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- BackgroundRice AD, Patterson K, Wurn BF, King CR and Wurn LJ. Update on "Decreasing dyspareunia and dysmenorrhea in women with endometriosis via a manual physical therapy: results from 2 independent studies". Journal of Endometriosis and Pelvic Pain Disorders, 6(3):161-162, 2014.
- BackgroundWurn BF, Wurn LJ, Patterson K, King CR, Scharf ES. Decreasing dyspareunia and dysmenorrhea in women with endometriosis via a manual physical therapy: Results from two independent studies. Journal of Endometriosis and Pelvic Pain Disorders 3(4):188-196, 2011.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence J Wurn, LMT principal investigator
Clear Passage Therapies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Pelvic Pain, run by Clear Passage Therapies, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reported overall pain rating (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03118154, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.