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NCT Number: NCT02464475

Effects of OMT on Interoception

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chieti-Pescara

Chieti, 66100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronic low back pain
  • written informed consent signed

Exclusion criteria

  • 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

Treatment and study plan

Osteopathic manipulative treatment

Other

Sham osteopathic treatment

Other

Primary outcomes

  1. functional connectivity on right anterior insula cortex

    Time frame: 4 weeks

    before-after change in fMRI values

Secondary outcomes

  1. differences on salience network activities

    Time frame: 4 weeks

    report any change between study and control group on pattern activation of salience network

  2. acute changes on salience network

    Time frame: 2 hours

    voxel differences

  3. resting state network differences between groups

    Time frame: 4 weeks

    voxel differences

  4. DTI changes between groups

    Time frame: 4 weeks

    differences in DTI parameters and indexes

  5. changes in GABA concentration

    Time frame: 4 weeks

    amount of GABA in the given voxel

  6. changes in quality of life

    Time frame: 4 weeks

    SF-36v2 self-reported questionnaire

  7. changes in perception of pain

    Time frame: 4 weeks

    McGill self-reported questionnaire

  8. changes in disability

    Time frame: 4 weeks

    Oswestry disability questionnaire

  9. changes in depression symptoms

    Time frame: 4 weeks

    Beck Depression Inventory questionnaire

  10. changes in anxiety symptoms

    Time frame: 4 weeks

    Hospital Anxiety and Depression Scale questionnaire

Sponsors and collaborators

Lead sponsor

Come Collaboration

Other

Collaborators

  • University of Chieti

Registry information

Official study title

Effects of Osteopathic Manual Treatment on Interoception: 2- Armed RCT on cLBP Patients

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2015
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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