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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- University of Alcala
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Changes from baseline in pain on the 10-point Visual Analog Scale (VAS, 0-10 score) at immediatelypost-needling and a week after.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Sebastián Rodríguez PosadaSebastián Rodríguez Posada
Principal investigator
University of Alcala
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.
Outcomes
Primary Outcomes
Changes from baseline in pain on the 10-point Visual Analog Scale (VAS, 0-10 score) at immediatelypost-needling and a week after.
Time Frame: 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 Outcomes
- 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.)
- Histograms using image analysis(Baseline, immediately post-needling and a week after.)
- Disability(Baseline, immediately post-needling and a week after.)
- Contraction time measured in milliseconds with M-mode(Baseline, immediately post-needling and a week after.)