Biomarkers of Pain and Stress Perception and Dry Needling Technique Application

NCT06355752 | Completed

• 1 other identifier: 0018-N-23
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The use of the dry needling technique has become widespread in recent years for the treatment of musculoskeletal pain. Although dry needling has been shown to be effective in the treatment of shoulder pain, elbow pain, headache, etc., we do not yet have a clear understanding of the mechanisms of action that justify its beneficial effects. In this study, we propose to analyse the biochemical markers of pain generated by the application of a dry needling technique on the lumbar musculature in patients with mechanical lumbar pain of non-specific origin. The aim of this study will be to evaluate the effects of dry needling technique on the plasmatic concentration of biochemical markers.Furthermore, the test subjects will be randomly distributed into two groups. An experimental group where the subjects will receive a real dry needling technique. Another group will be treated with a sham technique.

Conditions

Low Back Pain

Keywords

Low Back Pain; Dry needling; Biochemical Markers

Outcome Measures

Primary Outcomes (1)

• Extracting Blood Samples and Obtaining Serum/Plasma

  Serum samples will be extracted by venipuncture at the cubital fossa, according to a standardized protocol. Blood will be collected in a tube for serum (Vacutainer SST II Advance, model 367953) and a tube for plasma (Vacutainer PST II Advance, model 367374) separation. Substances related to antinociception will be determined later: Dopamine, adrenaline, norepinephrine, cortisol.

  Change from Baseline concentration at 2 hours

Study Arms (2)

Real dry needling

EXPERIMENTAL

Subjects included in this group will receive a session with dry needling in the quadratus lumborum muscle.

Other: Dry needling of lumbar iliocostalis muscle

Sham dry needling

SHAM COMPARATOR

Subjects included in this group will receive a session with sham dry needling in the quadratus lumborum muscle.

Other: Sham dry needling lumbar iliocostalis muscle

Interventions

Dry needling of lumbar iliocostalis muscle OTHER

Subjects will be treated with dry needling to the quadratus lumborum muscle. To do this, the subject will be lying laterally on the contralateral side and with the hip in an adducted position. Ten incisions will be made in the muscle. The head will rest comfortably on a pillow

Real dry needling

Sham dry needling lumbar iliocostalis muscle OTHER

Subjects will be treated with dry needling to the quadratus lumborum muscle. To do this, the subject will be lying laterally on the contralateral side and with the hip in an adducted position. The placebo needle will move 10 times imitating the real procedure. The head will rest comfortably on a pillow

Sham dry needling

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanical lumbar pain of more than three months of evolution.

You may not qualify if:

• Medical diagnosis of lumbar disc herniation or protrusion.
• Low back and leg pain.
• Pregnancy.
• Fibromyalgia.
• Fear of needles.
• Medication with anticoagulants

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Tomas Gallego-Izquierdo, PhD

  Centro de Investigación Fisioterapia y Dolor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 9, 2024
• Study Start: April 12, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

ES (1)