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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04415996
Other study ID # OST1-004
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2024
Est. completion date December 2024

Study information

Verified date April 2024
Source Escola Superior de Tecnologia da Saúde do Porto
Contact Natália MO Campelo, PhD
Phone 00351 22 206 1000
Email nmc@ess.ipp.pt
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this double-blinded study, the objective is to determine the effects of bilateral High Velocity Low Amplitude (HVLA) technique on L3/L4 joint in baropodometric pressures in 60 healthy young adults.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
HVLA L3/4
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
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.

Locations

Country Name City State
Portugal Escola Superior da Saúde do Porto Porto

Sponsors (1)

Lead Sponsor Collaborator
Escola Superior de Tecnologia da Saúde do Porto

Country where clinical trial is conducted

Portugal, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline of center of pressure displacement after 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
Secondary Change from Baseline of plantar pressure mean 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
Secondary Change from Baseline of plantar contact area 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. Immediately after the intervention
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