Effects of Lumbar Spinal Manipulation in Subjects With Chronic Low Back Pain (LBP-HVLA)

May 3, 2024 updated by: Lourdes García Luque, Universidad de Córdoba

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lourdes García Luque, PhD
  • Phone Number: 0034+ 627366324
  • Email: z12galul@uco.es

Study Contact Backup

Study Locations

  • Spain
      • Córdoba, Spain, 14011
        • Physiobalance
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sandra Alcaraz Clariana, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
A physical therapist, with more than 10 years of experience, performs a high-velocity low-amplitude spinal manipulation at the L5 level by means of the lumbar roll technique, performed with the subject in right lateral decubitus.
Other: spinal 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.
Other Names:
  • thrust
  • high-velocity low-amplitude
Placebo Comparator: Control Group
A physical therapist performance a simulated manipulation intervention, for which the same position as in the Intervention Group will be used, 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.
Other: simulated 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.
Other Names:
  • placebo intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain threshold
Time Frame: From enrollment to the end of treatment at 24 hours
An 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)
From enrollment to the end of treatment at 24 hours
Mechanical perception threshold
Time Frame: From enrollment to the end of treatment at 24 hours
It 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).
From enrollment to the end of treatment at 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Córdoba

Investigators

  • Principal Investigator: Lourdes García Luque, PhD, Universidad de Córdoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5874

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators have decided to first present the data in different forums and journals before making the database available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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