- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04415996
L3/L4 High Velocity Low Amplitude Technique Influence On Baropodometric Pressures In Healthy Young Adults
L3/L4 High Velocity Low Amplitude Technique Influence On Baropodometric Pressures In Healthy Young Adults: Randomized Controlled Trial
Study Overview
Detailed Description
The postural control it´s a fundamental aspect to understand the human´s capacity to perform activities. These balance is controlled by several mechanisms such as the proprioceptive system of muscles and articulation joints.
It is known that the High Velocity Low Amplitude (HVLA) technique shows biomechanical and neurophysiologic effects.
By saying that, it is importance to understand the effects of the lumbar manipulation on body´s weight distribution. Therefore, there is going to be measure several variables such as center of pressure oscillation , plantar pressure distribution and plantar contact area using a pressure platform.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Natália MO Campelo, PhD
- Phone Number: 00351 22 206 1000
- Email: nmc@ess.ipp.pt
Study Locations
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-
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Porto, Portugal, 4200-072
- Escola Superior da Saúde do Porto
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged between 18-25 years old;
- Individuals with BMI between 18,5 and 24,9 kg/m2
Exclusion Criteria:
- Pregnancy;
- With the follow conditions: lumbar discal hernia, spondylolisthesis with neurologic influence, narrowing of medullar canal, rheumatic disease, orthopaedic or neurologic conditions such as diminished sensibility, lack or absence of muscular strength, absence of patellar and/or aquilus reflexes;
- History of chirurgical intervention either on lumbar or lower limbs in the past 6 months;
- History of any trauma on the lumbar spine or lower limbs in the past 6 months;
- Any type of treatment on the lumbar in the previous month: that implicates physiotherapy, osteopathy, chiropractic, myofascial treatment, acupuncture or others;
- Medication that affects the vestibular system (dizziness, vertigo and humming)
- Pain during que experimental study;
- Difference between the length of the lower limbs: above 1.5cm;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HVLA L3/4 Group
In each participant, blind assessors will perform pre-intervention measurements of dislocation of center of pressure (CoP), plantar pressure mean and plantar contact area in a baropodometric pressure platform. Next, the investigator will perform the HVLA technique in L3/L4 joint articulation. Then, the same measurements before described will be repeated, by the assessors 1 minute after the intervention. |
The participant will be lateral decubitus and the investigator will locate the third lumbar vertebra.
Then with one hand the investigator will contact the interspinous space underlying L3 and with the other hand he will take the top leg into flexion until the investigator feels tension in L3/L4 joint.
Then he puls the tables´s arm until felling tension in the region to be manipulated.
Afterwards the investigator will globally rotate the participant in the horizontal plane and will approach to the L3/L4 joint.
With one arm the investigator will contact the deltopectoral groove and with the other one will contact the external iliac fossa.
Finally, the investigator will compress and rotate the pelvis and will apply an impulse in a rapid rotation, without losing the parameters with a "body drop" allowed by the flexion of the knees and the contraction of the large pectorals.
|
|
Sham Comparator: Control Group
In each participant, blind assessors will perform pre-intervention measurements of dislocation of center of pressure (CoP), plantar pressure mean and plantar contact area in a baropodometric pressure platform. Next, the investigator will perform a Sham technique. Then, the same measurements before described will be repeated, by the assessors 1 minute after the intervention. |
The participant will be in lateral decubitus and the top leg and knee will be flexed until the foot reaches the popliteal region of the other leg.
There won't be applied any tension in no structure.
This intervention will be applied during 20 seconds each side.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline of center of pressure displacement after intervention
Time Frame: Immediately after the intervention
|
To obtain the center of pressure displacement measurements, it will be used Emed / CL program.
This outcome will be measured either in sagittal plane in anteroposterior direction (x-axis) and in frontal plane in medial-lateral direction (y-axis) The participant will be standing in Emed pressure platform in upright position,with relaxed mouth, upper limbs along the body and feet shoulder-width apart, looking to an object standing 1 meter in front of participant´s eyes during 60 seconds.
The Emed/ CL program will determine the This procedure will be repeated 3 times.
The participant will rest sited on chair during 30 seconds between each measurements evaluation.
|
Immediately after the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline of plantar pressure mean
Time Frame: Immediately after the intervention
|
Plantar pressure mean is measure by Emed / CL program. It´s the average of all pressure values for each measurement, divided by the number of measurements for each sensor. The pressure unit used is Kilopascals (kPa). The participant will be standing in Emed pressure platform in upright position,with relaxed mouth, upper limbs along the body and feet shoulder-width apart, looking to an object standing 1 meter in front of participant´s eyes during 60 seconds. This procedure will be repeated 3 times. The participant will rest sited on chair during 30 seconds between each measurements evaluation. |
Immediately after the intervention
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Change from Baseline of plantar contact area
Time Frame: Immediately after the intervention
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Plantar contact area corresponds to the measurement of the contact region of the foot with the platform sensors.
It is determined by the sum of the area of all sensors activated within a given region.The plantar contact area unit is cm2 (square centimeters) The participant will be standing in Emed pressure platform in upright position,with relaxed mouth, upper limbs along the body and feet shoulder-width apart, looking to an object standing 1 meter in front of participant´s eyes during 60 seconds.
This procedure will be repeated 3 times.
The participant will rest sited on chair during 30 seconds between each measurements evaluation.
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Immediately after the intervention
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Collaborators and Investigators
Investigators
- Principal Investigator: Natália MO Campelo, PhD, Escola Superior da Saúde do Porto
Publications and helpful links
General Publications
- Gyer G, Michael J, Inklebarger J, Tedla JS. Spinal manipulation therapy: Is it all about the brain? A current review of the neurophysiological effects of manipulation. J Integr Med. 2019 Sep;17(5):328-337. doi: 10.1016/j.joim.2019.05.004. Epub 2019 May 9.
- Mendez-Sanchez R, Gonzalez-Iglesias J, Sanchez-Sanchez JL, Puente-Gonzalez AS. Immediate effects of bilateral sacroiliac joint manipulation on plantar pressure distribution in asymptomatic participants. J Altern Complement Med. 2014 Apr;20(4):251-7. doi: 10.1089/acm.2013.0192. Epub 2014 Feb 4.
- Grassi Dde O, de Souza MZ, Ferrareto SB, Montebelo MI, Guirro EC. Immediate and lasting improvements in weight distribution seen in baropodometry following a high-velocity, low-amplitude thrust manipulation of the sacroiliac joint. Man Ther. 2011 Oct;16(5):495-500. doi: 10.1016/j.math.2011.04.003. Epub 2011 May 14.
- Garcia AN, Gondo FL, Costa RA, Cyrillo FN, Silva TM, Costa LC, Costa LO. Effectiveness of the back school and mckenzie techniques in patients with chronic non-specific low back pain: a protocol of a randomised controlled trial. BMC Musculoskelet Disord. 2011 Aug 5;12:179. doi: 10.1186/1471-2474-12-179.
- Fagundes Loss J, de Souza da Silva L, Ferreira Miranda I, Groisman S, Santiago Wagner Neto E, Souza C, Tarrago Candotti C. Immediate effects of a lumbar spine manipulation on pain sensitivity and postural control in individuals with nonspecific low back pain: a randomized controlled trial. Chiropr Man Therap. 2020 Jun 3;28(1):25. doi: 10.1186/s12998-020-00316-7.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OST1-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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