NCT01965678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
Last Updated

October 18, 2013

Status Verified

October 1, 2013

Enrollment Period

1.6 years

First QC Date

October 16, 2013

Last Update Submit

October 17, 2013

Conditions

Muscle Skeletal Disorders

Keywords

Osteopathic manipulative treatmentmuscle-skeletal disorderquality of life

Outcome Measures

Primary Outcomes (1)

  • change from baseline in General Health score

    baseline and 1 month

Secondary Outcomes (2)

  • change from baseline in Physical Component score

    baseline and 1 month

  • change from baseline in Mental Component score

    baseline and 1 month

Study Arms (1)

OMT

EXPERIMENTAL
Other: Osteopathic Manipulative Treatment

Interventions

Osteopathic Manipulative TreatmentOTHER
OMT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • older than 18 years old
  • affected by muscle-skeletal disorder

You may not qualify if:

  • younger than 18 years old
  • OMT undertaken during the last 12 months
  • Any manual therapy received during the last 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Accademia Italiana Osteopatia Tradizionale

Pescara, 65121, Italy

Location

Related Publications (1)

  • 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.

    PMID: 25146065DERIVED

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2013

First Posted

October 18, 2013

Study Start

September 1, 2010

Primary Completion

April 1, 2012

Study Completion

June 1, 2012

Last Updated

October 18, 2013

Record last verified: 2013-10

Locations

IT(1)