Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02123693
Recruitment Status : Unknown
Verified September 2014 by European Institute for Evidence Based Osteopathic Medicine.
Recruitment status was:  Recruiting
First Posted : April 25, 2014
Last Update Posted : September 16, 2014
Sponsor:
Information provided by (Responsible Party):
European Institute for Evidence Based Osteopathic Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Osteopathic manipulative treatment Other: Sham Therapy Other: No Intervention Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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
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



Primary Outcome Measures :
  1. Baseline changes in degree of flection of lumbar spine [ Time Frame: at entry and after 8 weeks ]

Secondary Outcome Measures :
  1. Baseline changes in Visual Analogue Scale [ Time Frame: at entry and after 8 weeks ]
  2. Baseline changes in Roland-Morris questionnaire [ Time Frame: at entry and after 8 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02123693


Locations
Layout table for location information
Italy
Radiology Unit II, University Hospital San Salvatore L'Aquila Recruiting
L'Aquila, Abruzzo, Italy, 67100
Contact: Luca Cicchitti, DO    3925263387    cicchittiluca@gmail.com   
Sub-Investigator: Luca Cicchitti, DO         
Sponsors and Collaborators
European Institute for Evidence Based Osteopathic Medicine
Layout table for additonal information
Responsible Party: European Institute for Evidence Based Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT02123693    
Other Study ID Numbers: DYNOST-01
First Posted: April 25, 2014    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014
Keywords provided by European Institute for Evidence Based Osteopathic Medicine:
Osteopathic manipulative treatment
Low back pain
Dynamic MRI
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations