• Osteopathic Health Outcomes in Chronic Low Back Pain (OSTEOPATHIC) Trial

  NCT00315120

  CompletedInterventionalPhase 3Updated Jul 6, 2016
• Effects of Osteopathic Manipulative Treatment Associated With Pain Education and Clinical Hypnosis

  NCT05042115

  CompletedInterventionalNot ApplicableUpdated Mar 13, 2024
• Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain

  NCT03836248

  RecruitingInterventionalNot ApplicableUpdated Mar 6, 2026
• Cost Effectiveness of OMT for Chronic Low Back Pain

  NCT03532230

  CompletedObservationalUpdated May 4, 2020
• The Role of Osteopathic Treatment in the Axial Variations of the Lumbar Spine: RCT

  NCT02123693

  Unknown statusInterventionalNot ApplicableUpdated Sep 16, 2014
• Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific Low Back Pain

  NCT02752620

  CompletedInterventionalNot ApplicableUpdated Oct 12, 2016

ClinicalTrials.gov ID

NCT04277039

Lead Sponsor

Come CollaborationOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

216Estimated

Last Update Posted

Feb 20, 2020Actual

Start Date

Mar 1, 2020Estimated

Primary Completion Date

Mar 30, 2021Estimated

Completion Date

Jun 30, 2021Estimated

Official Title

Effects of Osteopathic Treatment in Combination With Cognitive Training on Low Back Pain Patients: a Randomised Sham-controlled Trial

Brief Summary

The objective of this study is to verify whether the combined approach (osteopathic manipulative treatment -OMT- and cognitive training -CT) is more effective in the long term than the individual approaches (OMT or CT) in patients with chronic lumbar pain, evaluating the Numeric Rating Scale (NRS) and the Rolland-Morris Disability Questionnaire (RMDQ) questionnaire

• Low Back Pain

• osteopathic treatment + cognitive training
• osteopathic treatment
• usual care

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• aged between 30 and 65 y
• diagnosis of aspecific chronic low back pain
• minimum of 3 on the NRS score

Exclusion Criteria:

• Neuropathic pain or chronic widespread pain
• 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Come CollaborationOTHER

Collaborators

Hospital General Universitario Santa LuciaOTHER

Niguarda HospitalOTHER

OrthoplusUNKNOWN

stefano.uberti@isoi.it3492624521

ghedinaosteopatia@gmail.com0471976433