Effects of Osteopathic Treatment With Cognitive Training on Low Back Pain
NCT ID: NCT04277039
Last Updated: 2020-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
216 participants
INTERVENTIONAL
2020-03-01
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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OMT+CT
It consists of 8 sessions of osteopathic treatment and two 20-min sessions of cognitive training per week per 2 months
osteopathic treatment + cognitive training
This intervention is a combination of manipulative osteopathic treatment and cognitive training to be administered each week for a 12-week study period
osteopathic treatment
It consists of 8 sessions of osteopathic treatment throughout the 2-month study period
osteopathic treatment
manual treatment using osteopathic procedure. 8 sessions for a 12 week study period
usual care
patients will continue the routine care as established by international guidelines
usual care
administration of non-steroid inflammatory drug according to international guidelines
Interventions
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osteopathic treatment + cognitive training
This intervention is a combination of manipulative osteopathic treatment and cognitive training to be administered each week for a 12-week study period
osteopathic treatment
manual treatment using osteopathic procedure. 8 sessions for a 12 week study period
usual care
administration of non-steroid inflammatory drug according to international guidelines
Eligibility Criteria
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Inclusion Criteria
* diagnosis of aspecific chronic low back pain
* minimum of 3 on the NRS score
Exclusion Criteria
* Low back spinal surgery in the last three years
* Low back spinal surgery to osteoporosis and/or traumatic fractures
* Rheumatic disease
* Pregnancy or having a baby in the last 12 months
* Painful disease in evidence through RX, MRI or CT in the last 6 months (listesis, moderate arthrosis, severe, algodystrophy etc.).
* The subjects have not to be treated with physical or manual therapies or psychotherapy in the last 6 months
30 Years
65 Years
ALL
No
Sponsors
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Hospital General Universitario Santa Lucia
OTHER
Niguarda Hospital
OTHER
Orthoplus
UNKNOWN
Come Collaboration
OTHER
Responsible Party
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Principal Investigators
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Francesco Cerritelli, PhD
Role: STUDY_CHAIR
Come Collaboration
Locations
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Santa Lucia Foundation
Rome, Lazio, Italy
Niguarda hospital
Milan, Lombardy, Italy
Orthoplus
Bolzano, Trentino-Alto Adige, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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COME-01-20
Identifier Type: -
Identifier Source: org_study_id
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