Epidemiological Study of Quality of Life in Osteopathy | NCT01965678

Studies
Epidemiological Study of Quality of Life in Osteopathy

NCT01965678

Sponsor

European Institute for Evidence Based Osteopathic Medicine

Status

Completed

Last Update Posted

Oct 18, 2013Estimated

Enrollment

1,000Actual

Phase

Not Applicable

Conditions

Muscle Skeletal Disorders

Interventions

Osteopathic Manipulative Treatment

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Apr 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Oct 16, 2013

First Submission Date that Met QC Criteria

Oct 17, 2013

First Posted Date

Oct 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2013

Last Update Posted Date

Oct 18, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Label	Type	Description	Intervention Names
OMT	Experimental		Other: Osteopathic Manipulative Treatment

Name	Type	Description	Arm Group Labels	Other Names
Osteopathic Manipulative Treatment	Other		OMT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change from baseline in General Health score		baseline and 1 month

Secondary Outcomes

Measure	Description	Time Frame
change from baseline in Physical Component score		baseline and 1 month
change from baseline in Mental Component score		baseline and 1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Accademia Italiana Osteopatia Tradizionale		Pescara		65121	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25146065	Derived	Cerritelli F, Verzella M, Barlafante G. Quality of life in patients referring to private osteopathic clinical practice: a prospective observational study. Complement Ther Med. 2014 Aug;22(4):625-31. doi: 10.1016/j.ctim.2014.05.007. Epub 2014 May 24.

ID	Term
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities