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Clinical Trials/NCT06399497
NCT06399497
Not yet recruiting
Not Applicable

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

Universidad de Córdoba1 site in 1 country34 target enrollmentMay 2024
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Universidad de Córdoba
Enrollment
34
Locations
1
Primary Endpoint
Muscle mechanical propierties
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2024
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad de Córdoba
Responsible Party
Principal Investigator
Principal Investigator

Lourdes García Luque

Principal Investigator

Universidad de Córdoba

Eligibility Criteria

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 L
  • Pregnant women.
  • Body Mass Index \> 30kg/m2
  • Subjects that have received treatment for low back pain in the seven days prior to the study.

Outcomes

Primary Outcomes

Muscle mechanical propierties

Time Frame: From enrollment to the end of treatment at 24 hours

The 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 Outcomes

  • Pressure pain threshold(From enrollment to the end of treatment at 24 hours)
  • Mechanical perception threshold(From enrollment to the end of treatment at 24 hours)

Study Sites (1)

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