Dry Needling Versus Percutaneous Electrolysis in Lumbar Multifidus Muscles in Patients With Chronic Low Back Pain. (DN-PE-LBP)

July 10, 2024 updated by: Leire López de Calle Sánchez, University of Alcala

Dry Needling Versus Percutaneous Electrolysis in Lumbar Multifidus Muscles in Patients With Chronic Low Back Pain

The aim of this study is to evaluate the reduction of pain of two different treatments in patients with chronic low back pain. Patients were divided in two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Low back pain is one of the most common health problems and a leading cause of disability and absence from work. Between 70% and 80% of adults will experience an episode of low back pain and approximately 10.0% of them will become chronic. This has a direct impact on the lumbar stabilizing muscles, giving rise to both structural and functional changes. Among the different treatment options, it has been observed that both dry needling (DN) and percutaneous electrolysis (PE) are effective techniques in the management of musculoskeletal pain.

Aim: To evaluate whether the reduction of pain after the application of PE is superior to the one obtained with DN.

Methods: A single-blind randomized clinical trial will be conducted in patients with chronic low back pain. The subjects will be divided into two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles. The study variables will be: pain (VAS), disability index (Oswestry Scale), fear of movement (TSK-11SV) and quality of life (SF-12). The measurements will be assessed before, right after and 7 days after a single intervention.

Study Type

Interventional

Enrollment (Estimated)

40

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 Contact Backup

Study Locations

  • Spain
    • Madrid
      • Alcalá De Henares, Madrid, Spain, 28805
        • Campus Científico-Tecnológico UAH. Av. de León, 3A
        • Contact:

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Low back pain ≥ 3 months.
  • Age between 30 and 60 years old.
  • Not being receiving other physical therapy

Exclusion Criteria:

  • Diagnosis of specific lumbar pathology.
  • History of previous lumbar surgery.
  • Treatment with corticosteroids, anti-inflammatory or antibiotic medication in recent weeks.
  • Oncological processes, febrile symptoms or thrombophlebitis.
  • Skin conditions.
  • Belonephobia.
  • Pacemaker.
  • Pregnancy.
  • Patients with neurological pathology

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dry needling group
The dry needling group will recibe a dry needling treatment with the Hong technique.
Other: Dry needling
It consists in application of dry needling on active and/or latent TPs in low back multifidus muscles
Experimental: Percutaneous electrolysis group
The percutaneous electrolysis grupos will recibe a tratement of galvanic current at 1.5mA, with 3-5 impacts, for 3-5 seconds in the low back multifiud muscles.
Other: Percutaneous electrolysis
It consists in the application of intratissue percutaneous electrolysis with galvanic current as a cathodic flow electrode in the low back multifidus muscles. The intervention will be guided by ultrasound equipment medically certified.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity. Visual analogue scale.
Time Frame: At baseline, at 1 week after the last intervention, and 6-month follow-up period
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain
At baseline, at 1 week after the last intervention, and 6-month follow-up period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability. Oswestry Low Back Pain Disability Idex
Time Frame: At baseline, at 1 week after the last intervention, and 6-month follow-up period
It has 10 items associated to activities of daily living, each item has a punctuation from 0 to 5 points
At baseline, at 1 week after the last intervention, and 6-month follow-up period
Fear of Movement. Tampa Scale of kinesiophobia (TSK-11SV)
Time Frame: At baseline, at 1 week after the last intervention, and 6-month follow-up period
Is a 11-item questionnaire that measures the fear of movement and (re)injury.
At baseline, at 1 week after the last intervention, and 6-month follow-up period
Quality of life. SF-12 Health questionnaire.
Time Frame: At baseline, at 1 week after the last intervention, and 6-month follow-up period
SF-12 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life
At baseline, at 1 week after the last intervention, and 6-month follow-up period

Collaborators and Investigators

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

Sponsor

University of Alcala

Investigators

  • Principal Investigator: Leire Lopez de Calle Sánchez, Grade, University of Alcala
  • Study Director: Samuel Fernandez Carnero, PhD, University of Alcala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

September 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dry needling Electrolysis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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