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

October 11, 2016 updated by: Frederico de Oliveira Meirelles, Rio de Janeiro State University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 5 weeks
VAS (VISUAL ANALOGUE SCALE)
5 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rio de Janeiro State University

Collaborators

Estácio S.A.

Investigators

  • Principal Investigator: Frederico Meirelles, Master /PT, UERJ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46194215.9.0000.5284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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