NCT01971983

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 18, 2014

Status Verified

October 1, 2013

Enrollment Period

1.3 years

First QC Date

October 24, 2013

Last Update Submit

March 15, 2014

Conditions

Keywords

Low back painSpinal manipulationOsteopathyMuscle energy techniqueMuscle thickness

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • Pressure pain threshold

    Immediate

  • Pressure pain threshold

    Two days

Study Arms (3)

HVLA

EXPERIMENTAL

The subjects allocated to this group will receive a 'High-velocity, low-amplitude (HVLA) technique over the lumbar spine.

Other: High-velocity, low-amplitude (HVLA)

ME

EXPERIMENTAL

Subjects allocated to this group will receive a muscle energy (ME) technique.

Other: Muscle energy (ME)

Sham group

SHAM COMPARATOR

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.

Other: Sham

Interventions

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.

Also known as: Thrust manipulation
HVLA

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.

Also known as: Mitchell's technique
ME
ShamOTHER

Individuals in this group received a sham intervention type, in order to simulate an intervention.

Sham group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Physiotherapy - The Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050170, Brazil

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Tocopherolssalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vitamin EBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Rodrigo F Angellos, Physiotherapis

    The Federal University of Health Sciences of Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

October 24, 2013

First Posted

October 30, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

March 18, 2014

Record last verified: 2013-10

Locations