Clinical trial NCT06399497: Effects of Lumbar Spinal Manipulation in Subjects With Chronic Low Back Pain
Official title: Effects of Lumbar Spinal Manipulation on Muscle Mechanical Properties, Pressure Pain Threshold and Mechanical Perception Threshold in Subjects With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Manipulation, Spinal
Muscle Mechanical Properties
Pain Threshold
Perception Threshold
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 L5.
* Pregnant women.
* Body Mass Index \&gt; 30kg/m2
* Subjects that have received treatment for low back pain in the seven days prior to the study.

Primary outcomes:
measure: Muscle mechanical propierties
timeFrame: From enrollment to the end of treatment at 24 hours
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: From enrollment to the end of treatment at 24 hours
measure: Mechanical perception threshold
timeFrame: From enrollment to the end of treatment at 24 hours
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Physiobalance
Study officials:
affiliation: Universidad de Córdoba
name: Lourdes García Luque, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lohr C, Braumann KM, Reer R, Schroeder J, Schmidt T. Reliability of tensiomyography and myotonometry in detecting mechanical and contractile characteristics of the lumbar erector spinae in healthy volunteers. Eur J Appl Physiol. 2018 Jul;118(7):1349-1359. doi: 10.1007/s00421-018-3867-2. Epub 2018 Apr 20.
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