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

Universidad de Córdoba

Status: Not yet enrolling

Conditions: Low Back Pain

Treatments: Other: simulated manipulation; Other: spinal manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06399497

5874

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

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.

Treatment:

Other: spinal manipulation

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Other: simulated manipulation