Effect of Two Osteopathic Techniques on Thickness of Paravertebral Muscles of the Lumbar Spine

Low Back Pain Clinical Trial

Official title:

Effect of Two Osteopathic Techniques on Thickness of Paravertebral Muscles of the Lumbar Spine: Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01971983
• Other study ID #: Osteo-ufcspa
• 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

• Low Back Pain

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