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NCT Number: NCT06505161

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.

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Key information

Conditions

Chronic Low-back Pain

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus Científico-Tecnológico UAH. Av. de León, 3A

Alcalá de Henares, Madrid, 28805, Spain

Location contact

Leire López de Calle Sánchez, Grade

CONTACT

[email protected]

+34661620517

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

dry needling

Other

It consists in application of dry needling on active and/or latent TPs in low back multifidus muscles

Percutaneous electrolysis

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Leire Lopez de Calle Sánchez, Grade

CONTACT

[email protected]

+34661620517

Samuel Fernandez Carnero, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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

Acronym: DN-PE-LBP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2024
Registry last updated
Jul 17, 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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