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

NCT05067673 | Completed

• 1 other identifier: 210108
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

lower back pain; dry needling; ultrasound; disability

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in pain on the 10-point Visual Analog Scale (VAS, 0-10 score) at immediatelypost-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.

  Baseline, immediately post-needling and a week after.

Secondary Outcomes (5)

• Thickness of lumbar multifidus measured with Rehabilitive Ultrasound Imaging in millimeters

  Baseline, immediately post-needling and a week after.

• Histograms using image analysis

  Baseline, immediately post-needling and a week after.

• Pressure Pain threshold

  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.

Study Arms (2)

Control group

PLACEBO COMPARATOR

Placebo dry needling

Other: Placebo dry needling

Experimental group

EXPERIMENTAL

Dry needling

Other: Dry needling

Interventions

Dry needling OTHER

The dry needling will be performed using disposable stainless steel needles (AGU-PUNT needles of size 0.30x50mm or 0.30x60mm depending on the patient) that will be inserted perpendicularly at the point of major hyperalgesia using the Hong technique. The patient will be in the prone position with a pillow placed in the abdominal region. The area will be cleaned with an antiseptic and allowed to air dry for 3 minutes. After this time, the needle will be inserted at the point indicated by the evaluator before reaching the lumbar multifidus by means of echolocation. Once it is assured that it is in the right place, a total of 10 repetitions are performed. The needle will be removed by depositing it in a needle container and a compression will be removed in the treated area until hemostasis is achieved.

Experimental group

Placebo dry needling OTHER

Placebo dry needling will be performed with DongBang DB100 Acupuncture Needles which, upon contact with the patient, retract, hiding in the needle handle. The patient will be in the prone position with a pillow in the abdominal region. The area will be cleaned with an antiseptic and allowed to air dry for 3 minutes. At the point indicated by the evaluator, the placebo needle will be placed initially and the introduction of the needle and its location will be simulated with the ultrasound system. 10 repetitions will be performed. The needle will be removed by depositing it in a needle container and a compression will be made in the treated area.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Sebastian

Torrejón de Ardoz, Madrid, 28850, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind randomized clinical trial in parallel groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 5, 2021
• Study Start: October 1, 2021
• Primary Completion: October 8, 2021
• Study Completion: October 8, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)