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Completed

NCT Number: NCT06355752

Biomarkers of Pain and Stress Perception and Dry Needling Technique Application

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28805, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

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

Primary outcomes

  1. Extracting Blood Samples and Obtaining Serum/Plasma

    Time frame: Change from Baseline concentration at 2 hours

    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.

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

Changes in Biomarkers of Pain and Stress Perception After the Application of a Dry Needling Technique in Patients With Low Back Pain

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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