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

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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Osteopathic Manipulative Treatment; Other: Exercise Therapy

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21
    • Estácio de Sá University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osteopathic Manipulative Treatment; We selected two types of osteopathic techniques for this study: Technical articulation: rhythmic technique with low speed in which the goal is the full gain range of motion. Myofascial techniques (Neuromuscular): techniques involving lateral stretching, linear, deep pressures and pulls of the origins and insertions aiming at a myofascial relaxation. Sacroiliac articulatory technique; Dorsal articulatory technique; Lumbar paraspinal muscles stretching technique; Lumbar myofascial technique (inhibitory).	Other: Osteopathic Manipulative Treatment
Active Comparator: Exercise Therapy; 2 types of therapeutic exercises techniques were used: Stabilization exercises; Stretches Stabilization exercises: Bridge on the ball 10 - 15 sec Side plank 10 - 15 sec Front board 10 - 15 sec active mobilization lumbopelvic 3 x 6 rep Squats with the ball on the wall 3 x 8 rep Static-passive stretch (2 x 30 sec): Paraspinal; Abdominals; Quadratus lumborum; Hip extenders; Hip flexors; Hip abductors; Hip adductors.	Other: Exercise Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	VAS (VISUAL ANALOGUE SCALE)	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability	Oswestry Disability Index 2.0	5 weeks
kinesiophobia	Tampa Scale for Kinesiophobia	5 weeks
Depression	Beck Scale for Depression	5 weeks

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University
• Collaborators: Estácio S.A.
• Investigators: Principal Investigator: Frederico Meirelles, Master /PT, UERJ

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: April 23, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (Estimate): April 27, 2016

Study Record Updates

• Last Update Posted (Estimate): October 12, 2016
• Last Update Submitted That Met QC Criteria: October 11, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: low back pain; osteopathic manipulative treatment; Chronic nonspecific low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 46194215.9.0000.5284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No