Biomarkers of Pain and Stress Perception and Dry Needling Technique Application

NCT ID: NCT06355752

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-12

Study Completion Date

2024-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Low Back Pain Dry needling Biochemical Markers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Real dry needling

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

Group Type EXPERIMENTAL

Dry needling of lumbar iliocostalis muscle

Intervention Type 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

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

Group Type SHAM_COMPARATOR

Sham dry needling lumbar iliocostalis muscle

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alcala

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Dr. Daniel Pecos Martín

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tomas Gallego-Izquierdo, PhD

Role: STUDY_CHAIR

Centro de Investigación Fisioterapia y Dolor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0018-N-23

Identifier Type: -

Identifier Source: org_study_id