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Effects of Lumbar Spinal Manipulation in Subjects With Chronic Low Back Pain

Effects of Lumbar Spinal Manipulation on Muscle Mechanical Properties, Pressure Pain Threshold and Mechanical Perception Threshold in Subjects With Chronic Low Back Pain

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06399497
Acronym
LBP-HVLA
Enrollment
34
Registered
2024-05-03
Start date
2024-05-31
Completion date
2025-12-31
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Manipulation, Spinal, Muscle Mechanical Properties, Pain Threshold, Perception Threshold

Brief summary

This study aims to measure the effects of spinal manipulation on Chronic Spinal Pain by assessing Muscle Mechanical Properties (MMPs) using MyotonPRO®, Mechanical Perception Threshold (MPT) using Von Frey monofilaments, and Pressure Pain Threshold (PPT) using an algometer. Participants will be randomly assigned to either spinal manipulation or placebo groups to compare effects on MMPs, MPT, and PPT. Assessments will occur at three time points: baseline, immediately post-intervention (real or simulated), and 24 hours post-intervention. This research targets individuals with chronic spinal pain, providing insights into the potential benefits of spinal manipulation in managing this condition.

Interventions

OTHERspinal manipulation

A high-velocity low-amplitude spinal manipulation at the L5 level will be performance by means of the lumbar roll technique, with the subject in right lateral decubitus.

OTHERsimulated manipulation

Simulated manipulation intervention, in the same position as in the Intervention Group, performance in right lateral decubitus with the left leg flexed and the left foot resting on the right popliteal fossa. Without stretching the paravertebral tissues, the participant will remain for approximately 20 seconds without receiving manual impulse.

Sponsors

Universidad de Córdoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The assessor will be blinded to the intervention assigned to each participant.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Subject with chronic low back pain

Exclusion criteria

* Spinal trauma or surgery history. * Spinal congenital deformities. * Inflammatory or autoimmune disease * Herniated disc in the segment L5. * Pregnant women. * Body Mass Index > 30kg/m2 * Subjects that have received treatment for low back pain in the seven days prior to the study.

Design outcomes

Primary

MeasureTime frameDescription
Muscle mechanical propiertiesFrom enrollment to the end of treatment at 24 hoursThe measurements will be performed with the MyotonPro®. The subject will be positioned in prone position with both upper limbs around the body. They will be asked to breathe apnea for five seconds after exhaling to reduce the abdominal influence on the test. Measurements at the lumbar level will be performed by positioning the MyotonPro® probe perpendicular to the muscle belly of the erector spinae, 2.5 cm from the midline of the spinous process of L5. A measurement of the tibialis anterior will assess the effect of the remote manipulation. For this purpose, the subject will be positioned in supine decubitus with the lower limb in extension. A point will be located on the tibialis anterior muscle, three finger traverses from the crest of the tibia in a caudal direction.

Secondary

MeasureTime frameDescription
Pressure pain thresholdFrom enrollment to the end of treatment at 24 hoursAn Algometer Commander™ JTECH will be used. Prior to the measurements, the subject will be familiarized with the evaluation by taking three measurements in the tenar region of the hand. During this phase, the subject will be asked to indicate, with eyes closed, the moment in which he perceives the painful sensation. The test will consist of a combination of three measurements administered to each muscle, with an interval between measurements of 3 to 5 seconds. The pressure stimulation will be applied with an algometer, gradually increasing the pressure by 0.5 kg per second until the subject manifests pain. The mean pressure at which the subject manifested pain will be calculated from these three measurements. The algometer will be placed perpendicular to the muscle bellies, and the subject will maintain the same position as in the measurement of the muscle mechanical propierties. The evaluation locations will be the L5 spinal Level and the tibialis anterior (bilaterally)
Mechanical perception thresholdFrom enrollment to the end of treatment at 24 hoursIt will be evaluated by means of Von Frey monofilaments, which will be applied perpendicularly to the cutaneous surface, with ascending diameter consecutively until the patient reports tactile perception. Prior to the measurements, the subject will be familiarized with the evaluation by taking three measurements in the tenar region of the hand. During this phase, the subject will be asked to indicate, with eyes closed, the moment in which he perceives the pressure sensation. The evaluation sites will be the same as in the MMPs: L5 level. Anterior tibial (bilaterally).

Countries

Spain

Contacts

Primary ContactLourdes García Luque, PhD
z12galul@uco.es0034+ 627366324
Backup ContactSandra Alcaraz Clariana, PhD
sandra_fi@hotmail.com0034+ 625434043

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026