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NCT02123693 Clinical Trial

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

Low Back Pain Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02123693
Other study ID # DYNOST-01
Secondary ID
Status Recruiting
Phase N/A
First received April 24, 2014
Last updated September 15, 2014
Start date June 2014
Est. completion date February 2015

Study information
Verified date September 2014
Source European Institute for Evidence Based Osteopathic Medicine
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date February 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 35 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Osteopathic manipulative treatment

• Sham Therapy

• No Intervention

Locations
Country Name City State
Italy Radiology Unit II, University Hospital San Salvatore L'Aquila L'Aquila Abruzzo

Sponsors (1)
Lead Sponsor Collaborator
European Institute for Evidence Based Osteopathic Medicine

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Baseline changes in degree of flection of lumbar spine at entry and after 8 weeks No
Secondary Baseline changes in Visual Analogue Scale at entry and after 8 weeks No
Secondary Baseline changes in Roland-Morris questionnaire at entry and after 8 weeks No
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