Muscle Skeletal DisordersESoQoLiONCT01965678
Epidemiological Study of Quality of Life in Osteopathy
A study testing Osteopathic Manipulative Treatment in people with Muscle Skeletal Disorders, run by European Institute for Evidence Based Osteopathic Medicine at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Muscle Skeletal Disorders
- What is being tested?
- Osteopathic Manipulative Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2010to Jun 2012
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 years old
- affected by muscle-skeletal disorder
Who cannot join
- younger than 18 years old
- OMT undertaken during the last 12 months
- Any manual therapy received during the last 12 months
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Muscle Skeletal Disorders
- Being tested
- Osteopathic Manipulative Treatment
- Keywords
- Osteopathic manipulative treatment, muscle-skeletal disorder, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentOther
| Study group | Role | What they receive |
|---|---|---|
| OMT | Experimental | Not described Receives: Other: Osteopathic Manipulative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in General Health score
Measured: baseline and 1 month
Secondary outcomes (2)
change from baseline in Physical Component score
Measured: baseline and 1 month
change from baseline in Mental Component score
Measured: baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startSep 2010
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle Skeletal DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute for Evidence Based Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965678
- Sponsor's protocol ID
- ESoQoLiO-1
- Acronym
- ESoQoLiO
- Status last verified
- Oct 2013
- First submitted
- 16 Oct 2013
- Last updated
- 18 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25146065
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Quality of Life in Osteopathy
- ClinicalTrials.gov ID
- NCT01965678
- Acronym / sponsor ID
- ESoQoLiO / ESoQoLiO-1
- Conditions
- Muscle Skeletal Disorders
- Keywords
- Osteopathic manipulative treatment, muscle-skeletal disorder, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- European Institute for Evidence Based Osteopathic MedicineUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Oct 2013 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OMT | Experimental | Other: Osteopathic Manipulative Treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- older than 18 years old
- affected by muscle-skeletal disorder
Key exclusion criteria (3 listed)
- younger than 18 years old
- OMT undertaken during the last 12 months
- Any manual therapy received during the last 12 months
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 |
|---|---|---|
| Osteopathic Manipulative Treatment | Other | OMT |
Primary outcome
change from baseline in General Health score
Time frame: baseline and 1 month
2 secondary outcomes
change from baseline in Physical Component score
Time frame: baseline and 1 month
change from baseline in Mental Component score
Time frame: baseline and 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2013.
- Derived from this study: PubMed 25146065Cerritelli 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.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment in people with Muscle Skeletal Disorders, run by European Institute for Evidence Based Osteopathic Medicine at 1 site in Italy.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Oct 2013. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change from baseline in General Health score (time frame: baseline and 1 month). 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 NCT01965678, which also lists 1 linked publication.
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 18 Oct 2013; AzTrials last refreshed its copy on 7 Nov 2026.