Tissue Changes in Lumbar Multifidus After Dry Needling in Subjects With Nonspecific Low Back Pain.

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Dry needling; Other: Placebo dry needling

• Registration Number: NCT05067673
• Lead Sponsor: University of Alcala

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.

Study Timeline

• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-23
• Study Start: 2021-10-01
• Study First Posted: 2021-10-05
• Primary Completion: 2021-10-08
• Study Completion: 2021-10-08
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-20
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Dry needling	Dry needling
Control group	Placebo dry needling	Placebo dry needling

Primary Outcome Measures

Name	Time	Method
Changes from baseline in pain on the 10-point Visual Analog Scale (VAS, 0-10 score) at immediatelypost-needling and a week after.	Baseline, immediately post-needling and a week after.	This scale shows concurrent and predictive validity in the assessment of pain. A difference of 2 points represents a clinically significant change that exceeds the limits of measurement error.

Secondary Outcome Measures

Name	Time	Method
Thickness of lumbar multifidus measured with Rehabilitive Ultrasound Imaging in millimeters	Baseline, immediately post-needling and a week after.
Pressure Pain threshold	Baseline, immediately post-needling and a week after.	It will be measured by using a pressure algometer. Lumbar multifidus algometry is performed approximately 1.5 cm from the spinous process of the level to be evaluated. The measurement will be taken 3 times to avoid variability by instructing patients to say verbally when they begin to feel pain.
Histograms using image analysis	Baseline, immediately post-needling and a week after.
Disability	Baseline, immediately post-needling and a week after.	it will be measured using the Roland-Morris questionnaire. Values range from 0 (absence of disability) to 24 (maximum level of disability).
Contraction time measured in milliseconds with M-mode	Baseline, immediately post-needling and a week after.	The patient performs a hip extension in the prone position

Trial Locations

Locations (1)

Sebastian; 🇪🇸 Torrejón De Ardoz, Madrid, Spain