L3/L4 High Velocity Low Amplitude Technique Influence On Baropodometric Pressures In Healthy Young Adults

NCT04415996 | Not Yet Recruiting DMC

• 1 other identifier: OST1-004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Lumbar Manipulation; High Velocity Low Amplitude (HVLA) technique; Baropodometry; Osteopathy; Plantar Weight Distribution

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from Baseline of plantar pressure mean

  Immediately after the intervention

• Change from Baseline of plantar contact area

  Immediately after the intervention

Study Arms (2)

HVLA L3/4 Group

EXPERIMENTAL

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.

Other: HVLA L3/4

Control Group

SHAM COMPARATOR

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.

Other: Sham

Interventions

HVLA L3/4 OTHER

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.

HVLA L3/4 Group

Sham OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals aged between 18-25 years old;
• Individuals with BMI between 18,5 and 24,9 kg/m2

You may not qualify if:

• 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;

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Study Sites (1)

Escola Superior da Saúde do Porto

Porto, 4200-072, Portugal

Location

Related Publications (5)

• 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.

  PMID: 24494737 BACKGROUND

• 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.

  PMID: 31105036 BACKGROUND

• 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.

  PMID: 21570892 BACKGROUND

• 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.

  PMID: 21819594 BACKGROUND

• 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.

  PMID: 32487243 BACKGROUND

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

• Natália MO Campelo, PhD

  Escola Superior da Saúde do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natália MO Campelo, PhD

CONTACT

00351 22 206 1000; nmc@ess.ipp.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Each participant will pull from a bag within equally number of folded papers with letter A (Intervention Group) and letter B (Control Group) and it will be handled to the investigator. The outcome assessors won´t also have any contact with the investigator and participant whilst intervention.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 4, 2020
• Study Start: September 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

PT (1)