- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01971983
Effect of Two Osteopathic Techniques on Thickness of Paravertebral Muscles of the Lumbar Spine
Effect of Two Osteopathic Techniques on Thickness of Paravertebral Muscles of the Lumbar Spine: Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90050170
- Laboratory of Physiotherapy - The Federal University of Health Sciences of Porto Alegre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: HVLA
The subjects allocated to this group will receive a 'High-velocity, low-amplitude (HVLA) technique over the lumbar spine.
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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.
Other Names:
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Experimental: ME
Subjects allocated to this group will receive a muscle energy (ME) technique.
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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.
Other Names:
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Sham Comparator: Sham group
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.
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Individuals in this group received a sham intervention type, in order to simulate an intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Muscle thickness
Time Frame: immediate
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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.
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immediate
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Muscle thickness
Time Frame: Two days
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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.
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Two days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pressure pain threshold
Time Frame: Immediate
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subjects will be evaluated regarding their pressure pain threshold (PPT) on the spinous process of all of the lumbar vertebrae.
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Immediate
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Pressure pain threshold
Time Frame: Two days
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subjects will be evaluated regarding their pressure pain threshold (PPT) on the spinous process of all of the lumbar vertebrae.
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Two days
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Collaborators and Investigators
Investigators
- Principal Investigator: Rodrigo F Angellos, Physiotherapis, The Federal University of Health Sciences of Porto Alegre
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Osteo-ufcspa
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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