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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01971983
Other study ID # Osteo-ufcspa
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 24, 2013
Last updated March 15, 2014
Start date February 2013
Est. completion date December 2014

Study information

Verified date October 2013
Source Federal University of Health Science of Porto Alegre
Contact n/a
Is FDA regulated No
Health authority Brazil: CEP - UFCSPA
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date December 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
High-velocity, low-amplitude (HVLA)
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.
Muscle energy (ME)
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.
Sham
Individuals in this group received a sham intervention type, in order to simulate an intervention.

Locations

Country Name City State
Brazil Laboratory of Physiotherapy - The Federal University of Health Sciences of Porto Alegre Porto Alegre Rio Grande do Sul

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. immediate No
Primary 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. Two days No
Secondary Pressure pain threshold subjects will be evaluated regarding their pressure pain threshold (PPT) on the spinous process of all of the lumbar vertebrae. Immediate No
Secondary Pressure pain threshold subjects will be evaluated regarding their pressure pain threshold (PPT) on the spinous process of all of the lumbar vertebrae. Two days No
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