Biomarkers of Pain and Stress Perception and Dry Needling Technique Application

April 12, 2024 updated by: Prof. Dr. Daniel Pecos Martín, University of Alcala

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real dry needling
Subjects included in this group will receive a session with dry needling in the quadratus lumborum muscle.
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 Comparator: Sham dry needling
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline concentration at 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Investigators

  • Study Chair: Tomas Gallego-Izquierdo, PhD, Centro de Investigación Fisioterapia y Dolor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2024

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

July 15, 2024

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0018-N-23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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