The Role of Osteopathic Treatment in the Axial Variations of the Lumbar Spine: RCT

NCT ID: NCT02123693

Last Updated: 2014-09-16

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-02-28

Brief Summary

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The aim of the present study is to determine whether there is a relationship between osteopathic treatment and the change of physiological axes of the lumbar spine, through the use of Dynamic Magnetic Resonance Imaging.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Osteopathic Manipulative Treatment

5 sessions of treatment will be carried out: the first 3 weekly, and the remaining 2 after 15 days. The type of treatment will be based on indirect techniques

Group Type EXPERIMENTAL

Osteopathic manipulative treatment

Intervention Type OTHER

Sham therapy

5 sessions of treatment will be carried out: the first 3 weekly, and the remaining 2 after 15 days. The type of treatment will be based on specific parameters set out previously based on a predetermined protocol

Group Type SHAM_COMPARATOR

Sham Therapy

Intervention Type OTHER

No intervention

Patients in this group will not receive any type of intervention, both therapeutic than fictitious, and will not be evaluated by any operator

Group Type OTHER

No Intervention

Intervention Type OTHER

Interventions

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Osteopathic manipulative treatment

Intervention Type OTHER

Sham Therapy

Intervention Type OTHER

No Intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* will be admitted patients of both genders
* patients with chronic low back pain at baseline
* patients aged between 18 and 35 years

Exclusion Criteria

* patients diagnosed with the disease of the musculoskeletal system or congenital malformation of the column
* patients with disorders of the pelvic floor, or who have undergone surgery of the reproductive system
* patients with neurological disorders that can cause painful symptoms of lumbar segment
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute for Evidence Based Osteopathic Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Radiology Unit II, University Hospital San Salvatore L'Aquila

L’Aquila, Abruzzo, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Luca Cicchitti, DO

Role: primary

3925263387

Other Identifiers

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DYNOST-01

Identifier Type: -

Identifier Source: org_study_id

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