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

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Osteopathic manipulative treatment
Sham Therapy
No Intervention
Sponsored by
European Institute for Evidence Based Osteopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Osteopathic manipulative treatment, Low back pain, Dynamic MRI

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radiology Unit II, University Hospital San Salvatore L'AquilaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

Osteopathic Manipulative Treatment

Sham therapy

No intervention

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Baseline changes in degree of flection of lumbar spine

Secondary Outcome Measures

Baseline changes in Visual Analogue Scale
Baseline changes in Roland-Morris questionnaire

Full Information

First Posted
April 24, 2014
Last Updated
September 15, 2014
Sponsor
European Institute for Evidence Based Osteopathic Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02123693
Brief Title
The Role of Osteopathic Treatment in the Axial Variations of the Lumbar Spine: RCT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Institute for Evidence Based Osteopathic Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Osteopathic manipulative treatment, Low back pain, Dynamic MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic Manipulative Treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Sham therapy
Arm Type
Sham Comparator
Arm Description
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
Arm Title
No intervention
Arm Type
Other
Arm Description
Patients in this group will not receive any type of intervention, both therapeutic than fictitious, and will not be evaluated by any operator
Intervention Type
Other
Intervention Name(s)
Osteopathic manipulative treatment
Intervention Type
Other
Intervention Name(s)
Sham Therapy
Intervention Type
Other
Intervention Name(s)
No Intervention
Primary Outcome Measure Information:
Title
Baseline changes in degree of flection of lumbar spine
Time Frame
at entry and after 8 weeks
Secondary Outcome Measure Information:
Title
Baseline changes in Visual Analogue Scale
Time Frame
at entry and after 8 weeks
Title
Baseline changes in Roland-Morris questionnaire
Time Frame
at entry and after 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Radiology Unit II, University Hospital San Salvatore L'Aquila
City
L'Aquila
State/Province
Abruzzo
ZIP/Postal Code
67100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Cicchitti, DO
Phone
3925263387
Email
cicchittiluca@gmail.com
First Name & Middle Initial & Last Name & Degree
Luca Cicchitti, DO

12. IPD Sharing Statement

Learn more about this trial

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

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