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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment
Exercise Therapy
Sponsored by
Rio de Janeiro State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring osteopathic manipulative treatment, Chronic nonspecific low back pain, low back pain

Eligibility Criteria

30 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Estácio de Sá University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Osteopathic Manipulative Treatment

Exercise Therapy

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Pain
VAS (VISUAL ANALOGUE SCALE)

Secondary Outcome Measures

Disability
Oswestry Disability Index 2.0
kinesiophobia
Tampa Scale for Kinesiophobia
Depression
Beck Scale for Depression

Full Information

First Posted
April 23, 2016
Last Updated
October 11, 2016
Sponsor
Rio de Janeiro State University
Collaborators
Estácio S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02752620
Brief Title
Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific Low Back Pain
Official Title
Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific Low Back Pain: a Randomized Controlled and Double-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rio de Janeiro State University
Collaborators
Estácio S.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
osteopathic manipulative treatment, Chronic nonspecific low back pain, low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic Manipulative Treatment
Arm Type
Experimental
Arm Description
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).
Arm Title
Exercise Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Treatment
Intervention Type
Other
Intervention Name(s)
Exercise Therapy
Primary Outcome Measure Information:
Title
Pain
Description
VAS (VISUAL ANALOGUE SCALE)
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Disability
Description
Oswestry Disability Index 2.0
Time Frame
5 weeks
Title
kinesiophobia
Description
Tampa Scale for Kinesiophobia
Time Frame
5 weeks
Title
Depression
Description
Beck Scale for Depression
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederico Meirelles, Master /PT
Organizational Affiliation
UERJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Estácio de Sá University
City
Rio de Janeiro
ZIP/Postal Code
21
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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