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

September 15, 2014 updated by: European Institute for Evidence Based Osteopathic Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Abruzzo
      • L'Aquila, Abruzzo, Italy, 67100
        • Recruiting
        • Radiology Unit II, University Hospital San Salvatore L'Aquila
        • Contact:
        • Sub-Investigator:
          • Luca Cicchitti, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: Osteopathic manipulative treatment
Sham Comparator: 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
Other: Sham Therapy
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
Other: No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Baseline changes in degree of flection of lumbar spine
Time Frame: at entry and after 8 weeks
at entry and after 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Baseline changes in Visual Analogue Scale
Time Frame: at entry and after 8 weeks
at entry and after 8 weeks
Baseline changes in Roland-Morris questionnaire
Time Frame: at entry and after 8 weeks
at entry and after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute for Evidence Based Osteopathic Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 25, 2014

Study Record Updates

Last Update Posted (Estimate)

September 16, 2014

Last Update Submitted That Met QC Criteria

September 15, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DYNOST-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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