Biomarkers of Pain and Stress Perception and Dry Needling Technique Application

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06355752
• Other study ID #: 0018-N-23
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2024
• Est. completion date: July 15, 2024

Study information

• Verified date: April 2024
• Source: University of Alcala
• Contact: Patricia Martinez-Merinero, PhD
• Phone: +34 683378391
• Email: clinica.fisio[@]fgua.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Dry needling of lumbar iliocostalis muscle
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
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

Locations

Country	Name	City	State
Spain	Centro Investigación Fisioterapia y Dolor	Alcalá De Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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