Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific Low Back Pain

Low Back Pain Clinical Trial

Official title:

Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific Low Back Pain: a Randomized Controlled and Double-blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752620
• Other study ID #: 46194215.9.0000.5284
• Status: Completed
• Phase: N/A
• First received: April 23, 2016
• Last updated: October 11, 2016
• Start date: May 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effectiveness of treatment osteopathic manipulation in the treatment of subjects with chronic nonspecific low back pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 59 Years

Eligibility

Inclusion Criteria:

• Subjects with constant or intermittent low back pain with intensity greater than 30 mm visual analog scale (VAS) for at least three months duration, with a diagnosis of chronic low back pain

Exclusion Criteria:

• Subjects who have spine fractures,

• Dislocations

• Ligament ruptures

• Muscle ruptures

• Skin lacerations

• Sacroiliitis

• Vertebral osteomyelitis

• Infection

• Disc herniations with radicular symptoms

• Rheumatic disorders

• Cauda equina syndrome

• Tumors

• Referred pain visceral

• Red flags

• Lower limb discrepancy greater than 2 cm

• Several conditions requiring participants to be absent for more than two weeks of activities in the experiment

• Positioning itself as not volunteer the same.

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Osteopathic Manipulative Treatment

• Exercise Therapy

Locations

Country	Name	City	State
Brazil	Estácio de Sá University	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Rio de Janeiro State University	Estácio de Sá University, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	VAS (VISUAL ANALOGUE SCALE)	5 weeks	Yes
Secondary	Disability	Oswestry Disability Index 2.0	5 weeks	Yes
Secondary	kinesiophobia	Tampa Scale for Kinesiophobia	5 weeks	Yes
Secondary	Depression	Beck Scale for Depression	5 weeks	Yes