Effects of OMT on Interoception
Effects of Osteopathic Manual Treatment on Interoception: 2- Armed RCT on cLBP Patients
1 other identifier
interventional
40
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 25, 2019
March 1, 2019
2.1 years
May 28, 2015
March 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
functional connectivity on right anterior insula cortex
before-after change in fMRI values
4 weeks
Secondary Outcomes (10)
differences on salience network activities
4 weeks
acute changes on salience network
2 hours
resting state network differences between groups
4 weeks
DTI changes between groups
4 weeks
changes in GABA concentration
4 weeks
- +5 more secondary outcomes
Study Arms (2)
OMT
EXPERIMENTALSham
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- chronic low back pain
- written informed consent signed
You may not qualify if:
- 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
- obese subjects
- diabetics
- dizziness
- subjects into pharmacological prophylaxis
- drug addicted subjects
- subjects undergoing physiotherapy
- subjects with experience in osteopathic treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Come Collaborationlead
- University of Chieticollaborator
Study Sites (1)
University of Chieti-Pescara
Chieti, 66100, Italy
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Cerritelli, MS, DO
University of Chieti-Pescara
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DO, MS
Study Record Dates
First Submitted
May 28, 2015
First Posted
June 8, 2015
Study Start
June 1, 2015
Primary Completion
July 1, 2017
Study Completion
December 1, 2017
Last Updated
March 25, 2019
Record last verified: 2019-03