Back to resultsEffect of Two Osteopathic Techniques on Thickness of Paravertebral Muscles of the Lumbar Spine
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
High-velocity, low-amplitude (HVLA)
Muscle energy (ME)
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Spinal manipulation, Osteopathy, Muscle energy technique, Muscle thickness
Eligibility Criteria
Inclusion Criteria:
- At least one episode of low back pain over the last three months; confirmation of lumbar spine dysfunction by an experienced osteopath; age between 18 and 40 years; do not have performed physical stress activities over the last 24 hours; do not be physically active (physical activity for at least three times a week); fulfill the orientations to the follow-up assessment.
Exclusion Criteria:
- History of surgery, fracture or fixation on the lumbar spine and/or the pelvis; being pregnant; signs of radiculopathy; disc herniation at the lumbar spine; degenerative process at the lumbar spine; have received any kind of manipulative treatments over the past four weeks;
Sites / Locations
- Laboratory of Physiotherapy - The Federal University of Health Sciences of Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
HVLA
ME
Sham group
Arm Description
The subjects allocated to this group will receive a 'High-velocity, low-amplitude (HVLA) technique over the lumbar spine.
Subjects allocated to this group will receive a muscle energy (ME) technique.
The individuals allocated to this group received an intervention of the "sham". The sample of this group will consist of subjects with history of dysfunctions of the lumbar spine.
Outcomes
Primary Outcome Measures
Muscle thickness
We will evaluate the muscle thickness of four muscles that comprises the paravertebral musculature at the lumbar spine: internal oblique, external oblique, lumbar multifidus and transversus abdominis.
Muscle thickness
We will evaluate the muscle thickness of four muscles that comprises the paravertebral musculature at the lumbar spine: internal oblique, external oblique, lumbar multifidus and transversus abdominis.
Secondary Outcome Measures
Pressure pain threshold
subjects will be evaluated regarding their pressure pain threshold (PPT) on the spinous process of all of the lumbar vertebrae.
Pressure pain threshold
subjects will be evaluated regarding their pressure pain threshold (PPT) on the spinous process of all of the lumbar vertebrae.
Full Information
NCT ID
NCT01971983
First Posted
October 24, 2013
Last Updated
March 15, 2014
Sponsor
Federal University of Health Science of Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT01971983
Brief Title
Effect of Two Osteopathic Techniques on Thickness of Paravertebral Muscles of the Lumbar Spine
Official Title
Effect of Two Osteopathic Techniques on Thickness of Paravertebral Muscles of the Lumbar Spine: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this randomized controlled trial is to describe the effect of two osteopathic techniques - "high velocity, low amplitude" (HVLA) and muscle energy (ME) - on thickness, activation, strength, pressure pain threshold (PPT) of the paravertebral muscles at the lumbar spine, as well as the peak plantar pressures immediately and after a two-day follow-up.
The muscle thickness of the paravertebral muscles at the lumbar spine, namely internal oblique, external oblique and transversus abdominis can be altered after the application of 'high-velocity low-amplitude'(HVLA)and 'muscle energy' (ME)techniques immediately and after a two-day follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Spinal manipulation, Osteopathy, Muscle energy technique, Muscle thickness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HVLA
Arm Type
Experimental
Arm Description
The subjects allocated to this group will receive a 'High-velocity, low-amplitude (HVLA) technique over the lumbar spine.
Arm Title
ME
Arm Type
Experimental
Arm Description
Subjects allocated to this group will receive a muscle energy (ME) technique.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
The individuals allocated to this group received an intervention of the "sham". The sample of this group will consist of subjects with history of dysfunctions of the lumbar spine.
Intervention Type
Other
Intervention Name(s)
High-velocity, low-amplitude (HVLA)
Other Intervention Name(s)
Thrust manipulation
Intervention Description
With the subject lying on his/her side, the therapist will rotate the patient's trunk, flex his/her hip and knee of the upper leg. The therapist positions his caudad forearm over the hip, while the cephalad forearm lies over the patient's shoulder. The therapist's hands will be positioned over the lumbar spine's spinous process to be manipulated.
Intervention Type
Other
Intervention Name(s)
Muscle energy (ME)
Other Intervention Name(s)
Mitchell's technique
Intervention Description
This technique involves the active movement of the patient to activate a specific musculature in order to move a bony segment of a given joint in a specific direction in relation to the adjacent bone. This technique aims to restore the restricted movement of the joint in question.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Individuals in this group received a sham intervention type, in order to simulate an intervention.
Primary Outcome Measure Information:
Title
Muscle thickness
Description
We will evaluate the muscle thickness of four muscles that comprises the paravertebral musculature at the lumbar spine: internal oblique, external oblique, lumbar multifidus and transversus abdominis.
Time Frame
immediate
Title
Muscle thickness
Description
We will evaluate the muscle thickness of four muscles that comprises the paravertebral musculature at the lumbar spine: internal oblique, external oblique, lumbar multifidus and transversus abdominis.
Time Frame
Two days
Secondary Outcome Measure Information:
Title
Pressure pain threshold
Description
subjects will be evaluated regarding their pressure pain threshold (PPT) on the spinous process of all of the lumbar vertebrae.
Time Frame
Immediate
Title
Pressure pain threshold
Description
subjects will be evaluated regarding their pressure pain threshold (PPT) on the spinous process of all of the lumbar vertebrae.
Time Frame
Two days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least one episode of low back pain over the last three months; confirmation of lumbar spine dysfunction by an experienced osteopath; age between 18 and 40 years; do not have performed physical stress activities over the last 24 hours; do not be physically active (physical activity for at least three times a week); fulfill the orientations to the follow-up assessment.
Exclusion Criteria:
History of surgery, fracture or fixation on the lumbar spine and/or the pelvis; being pregnant; signs of radiculopathy; disc herniation at the lumbar spine; degenerative process at the lumbar spine; have received any kind of manipulative treatments over the past four weeks;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo F Angellos, Physiotherapis
Organizational Affiliation
The Federal University of Health Sciences of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Physiotherapy - The Federal University of Health Sciences of Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90050170
Country
Brazil
12. IPD Sharing Statement
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Effect of Two Osteopathic Techniques on Thickness of Paravertebral Muscles of the Lumbar Spine
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