Clinical trial NCT05067673: Tissue Changes in Lumbar Multifidus After Dry Needling in Subjects With Nonspecific Low Back Pain.
Official title: Association Between Tissue Changes in Lumbar Multifidae and Improvement in Pain and Disability After Dry Needling in Subjects With Nonspecific Low Back Pain. Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: lower back pain
dry needling
ultrasound
disability
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 70
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: Finding out if tissue changes (thickness, histogram and shrinkage rate) that occur in the lumbar multifidus after deep dry needling are related to changes in patient's pain and disability.

Detailed description: Lower back pain in regarded as the main cause of disability in the world, which has a significant socio-economic impact. Deep dry needling is effective in handling such pain and is one of the techniques of choice by physiotherapists. In this area, the use of ultrasound provides information of interest such as length, thickness, diameter, cross-sectional area or muscle volume, among others.

Objective: Finding out if tissue changes (thickness, histogram and shrinkage rate) that occur in the lumbar multifidus after deep dry needling are related to changes in patient's pain and disability.

It's a double-blind randomized clinical trial in parallel groups. Patients will be randomly divided into 2 groups. One of them will receive dry needling and the other dry needling placebo. The initial, post-needling and a week after evaluations will be performed by a blinded to the intervention therapist.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years.
* Nonspecific pain in the lumbar region.

Exclusion Criteria:

* Previous surgery in the lumbosacral spine.
* Osteoporosis.
* Needle phobia.
* Neurogenic pain with positive tests or negative symptoms.
* Red flags: cauda equina syndrome, sudden weight loss, fracture, cancer, infection or systemic diseases.
* Pregnancy.
* Physiotherapy intervention in the 4 weeks prior to the intervention.

Primary outcomes:
measure: Changes from baseline in pain on the 10-point Visual Analog Scale (VAS, 0-10 score) at immediatelypost-needling and a week after.
timeFrame: Baseline, immediately post-needling and a week after.
Secondary outcomes:
measure: Thickness of lumbar multifidus measured with Rehabilitive Ultrasound Imaging in millimeters
timeFrame: Baseline, immediately post-needling and a week after.
measure: Histograms using image analysis
timeFrame: Baseline, immediately post-needling and a week after.
measure: Pressure Pain threshold
timeFrame: Baseline, immediately post-needling and a week after.
measure: Disability
timeFrame: Baseline, immediately post-needling and a week after.
measure: Contraction time measured in milliseconds with M-mode
timeFrame: Baseline, immediately post-needling and a week after.
Other outcomes:
Locations:
city: Torrejón De Ardoz
country: Spain
facility: Sebastian
state: Madrid
Study officials:
References: