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

Not Applicable

• Conditions: Low Back Pain
• Interventions: Other: Sham Therapy; Other: Osteopathic manipulative treatment; Other: No Intervention

• Registration Number: NCT02123693
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-25
• Study Start: 2014-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-15
• Last Update Posted: 2014-09-16
• Primary Completion: 2014-12
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham therapy	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
Osteopathic Manipulative Treatment	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
No intervention	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

Primary Outcome Measures

Name	Time	Method
Baseline changes in degree of flection of lumbar spine	at entry and after 8 weeks

Secondary Outcome Measures

Name	Time	Method
Baseline changes in Visual Analogue Scale	at entry and after 8 weeks
Baseline changes in Roland-Morris questionnaire	at entry and after 8 weeks

Trial Locations

Locations (1)

Radiology Unit II, University Hospital San Salvatore L'Aquila; 🇮🇹 L'Aquila, Abruzzo, Italy