- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01965678
Epidemiological Study of Quality of Life in Osteopathy (ESoQoLiO)
October 17, 2013 updated by: European Institute for Evidence Based Osteopathic Medicine
Aim of this study is to evaluate the effectiveness of osteopathy in changing quality of life in a large sample of naive patients undergoing osteopathic manipulative treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pescara, Italy, 65121
- Accademia Italiana Osteopatia Tradizionale
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- older than 18 years old
- affected by muscle-skeletal disorder
Exclusion Criteria:
- younger than 18 years old
- OMT undertaken during the last 12 months
- Any manual therapy received during the last 12 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OMT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change from baseline in General Health score
Time Frame: baseline and 1 month
|
baseline and 1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change from baseline in Physical Component score
Time Frame: baseline and 1 month
|
baseline and 1 month
|
change from baseline in Mental Component score
Time Frame: baseline and 1 month
|
baseline and 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
October 16, 2013
First Submitted That Met QC Criteria
October 17, 2013
First Posted (Estimate)
October 18, 2013
Study Record Updates
Last Update Posted (Estimate)
October 18, 2013
Last Update Submitted That Met QC Criteria
October 17, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- ESoQoLiO-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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