Chronic Low Back PainNCT02464475
Effects of OMT on Interoception
A study testing osteopathic manipulative treatment in people with Chronic Low Back Pain, run by Come Collaboration at 1 site in Italy.
Trial summary
Recent evidence suggested that the anterior insula cortex seems to be the main site of interoception. Several studies showed an association between change in insula function and interoception, bodily perception and consciousness in subjects with chronic pain. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- osteopathic manipulative treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2015to Dec 2017
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic low back pain
- written informed consent signed
Who cannot join
- congenital disease
- acute pain
- subject below 30 and above 50
- co-morbidities associated with low back pain
- surgical patients
- cardio-vascular, respiratory, gastro-enteric disease
Show all 13Show fewer
- obese subjects
- diabetics
- dizziness
- subjects into pharmacological prophylaxis
- drug addicted subjects
- subjects undergoing physiotherapy
- subjects with experience in osteopathic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Osteopathic Manual Treatment on Interoception: 2- Armed RCT on cLBP Patients
Recent evidence suggested that the anterior insula cortex seems to be the main site of interoception. Several studies showed an association between change in insula function and interoception, bodily perception and consciousness in subjects with chronic pain. Although osteopathic research has been demonstrated to be effective in reducing pain, studies exploring the effect of osteopathy on interoception are lacking. Therefore, the aim of the present study is to explore the extent to which osteopathic treatment could modify interoception parameters both measuring brain functional connectivity and clinical questionnaires.
- Conditions
- Chronic Low Back Pain
- Being tested
- osteopathic manipulative treatment, sham osteopathic treatment
- Keywords
- osteopathic manipulative treatment, interoception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathic manipulative treatmentOther
sham osteopathic treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| OMT | Experimental | Not described Receives: Other: osteopathic manipulative treatment |
| Sham | Sham comparator | Not described Receives: Other: sham osteopathic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional connectivity on right anterior insula cortex
before-after change in fMRI values
Measured: 4 weeks
Secondary outcomes (10)
differences on salience network activities
report any change between study and control group on pattern activation of salience network
Measured: 4 weeks
acute changes on salience network
voxel differences
Measured: 2 hours
resting state network differences between groups
voxel differences
Measured: 4 weeks
DTI changes between groups
differences in DTI parameters and indexes
Measured: 4 weeks
changes in GABA concentration
amount of GABA in the given voxel
Measured: 4 weeks
changes in quality of life
SF-36v2 self-reported questionnaire
Measured: 4 weeks
changes in perception of pain
McGill self-reported questionnaire
Measured: 4 weeks
changes in disability
Oswestry disability questionnaire
Measured: 4 weeks
changes in depression symptoms
Beck Depression Inventory questionnaire
Measured: 4 weeks
changes in anxiety symptoms
Hospital Anxiety and Depression Scale questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Come Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chieti
- Responsible party
- Principal investigator, Francesco Cerritelli, Come Collaboration
- Investigators
- Francesco Cerritelli, MS, DO, Principal investigator, University of Chieti-Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464475
- Sponsor's protocol ID
- InterOST
- Status last verified
- Mar 2019
- First submitted
- 28 May 2015
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Osteopathic Manual Treatment on Interoception: 2- Armed RCT on cLBP Patients
- ClinicalTrials.gov ID
- NCT02464475
- Acronym / sponsor ID
- InterOST
- Conditions
- Chronic Low Back Pain
- Keywords
- osteopathic manipulative treatment, interoception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Come CollaborationUniversity, hospital or other
- Collaborators
- University of Chieti
- Study start
- Jun 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Jun 2015 (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.
Recent evidence suggested that the anterior insula cortex seems to be the main site of interoception. Several studies showed an association between change in insula function and interoception, bodily perception and consciousness in subjects with chronic pain. Although osteopathic research has been demonstrated to be effective in reducing pain, studies exploring the effect of osteopathy on interoception are lacking. Therefore, the aim of the present study is to explore the extent to which osteopathic treatment could modify interoception parameters both measuring brain functional connectivity and clinical questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMT | Experimental | Other: osteopathic manipulative treatment |
| Sham | Sham comparator | Other: sham osteopathic treatment |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- chronic low back pain
- written informed consent signed
Key exclusion criteria (13 listed)
- congenital disease
- acute pain
- subject below 30 and above 50
- co-morbidities associated with low back pain
- surgical patients
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 |
| sham osteopathic treatment | Other | Sham |
Primary outcome
functional connectivity on right anterior insula cortex
Time frame: 4 weeks
before-after change in fMRI values
10 secondary outcomes
differences on salience network activities
Time frame: 4 weeks
acute changes on salience network
Time frame: 2 hours
resting state network differences between groups
Time frame: 4 weeks
DTI changes between groups
Time frame: 4 weeks
changes in GABA concentration
Time frame: 4 weeks
changes in quality of life
Time frame: 4 weeks
changes in perception of pain
Time frame: 4 weeks
changes in disability
Time frame: 4 weeks
changes in depression symptoms
Time frame: 4 weeks
changes in anxiety symptoms
Time frame: 4 weeks
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 25 Mar 2019.
Related trials for Chronic Low Back Pain
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruiting
Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Low Back Pain, Core Muscles
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.
Francesco Cerritelli, MS, DO principal investigator
University of Chieti-Pescara
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 Chronic Low Back Pain, run by Come Collaboration 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 13 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 25 Mar 2019. 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. Some participants in this study may receive a placebo. 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?
functional connectivity on right anterior insula cortex (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2019.