Dry Needlig Vesus Tecartherapy in Low-back Pain Treatment

NCT ID: NCT05422040

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-20
• Study Completion Date: 2025-09-01

Brief Summary

Introduction: Diathermy is a new tool that could help subjects with chronic low back pain (CLBP), with no studies having compared it to other interventions already investigated such as dry needling.

Hypothesis: Diathermy is more effective than dry needling in improving pain intensity in the short term in subjects with CLBP.

Design: randomised controlled trial Methods: We will conduct a convenience sampling, with subjects receiving 2 treatment sessions with diathermy or dry needling, according to allocation. Subjects will be assessed at baseline, 1 week, 1 month and 3 months after treatment for pain intensity, disability, kinesiophobia and catastrophizing. Analysis of variance (ANOVA) and moderation analysis will be performed to evaluate the results, with 95% confidence intervals (CI).

Detailed Description

A prospective longitudinal experimental randomised controlled trial study will be conducted from August 2022 to March 2023. The study will be conducted in accordance with the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) statement,15 and in accordance with the Declaration of Helsinki.

Subjects were randomly assigned to one of the two intervention groups:

Diathermy. Diathermy treatment was applied using the TCaRe Power diathermy instrument (PRIM Physio©), using a capacitive system with an intensity of 50%, with slight variation depending on patient tolerance and 500khz. The therapy will be applied for 10 minutes on each side of the patient's lumbar region, who will be positioned in prone decubitus during the intervention.

The application will be active along with massage techniques. Dry needling. Dry needling is performed with a 4cm needle (APS Dry Needles®) on the most symptomatic side of the patient on palpation. To perform the technique, the patient is positioned in prone position on the couch. The physiotherapist palpates the lateral border of the lumbar iliocostalis muscle and performs the tapping technique in a latero-medial direction parallel to the stretcher.

The technique is performed by applying 12 incisions. After the application of the technique, ischaemic compression shall be performed for 1 minute.

Patients will complete a home exercise program

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dry needling

Dry needling is performed with a 4cm needle (APS Dry Needles®) on the most symptomatic side of the patient on palpation. To perform the technique, the patient is positioned in prone position on the couch. The physiotherapist palpates the lateral border of the lumbar iliocostalis muscle and performs the tapping technique in a latero-medial direction parallel to the stretcher.

The technique is performed by applying 12 incisions. After the application of the technique, ischaemic compression shall be performed for 1 minute.

Patients will complete a home exercise program

Group Type: EXPERIMENTAL

Dry needling

Intervention Type: OTHER

Invasive treatment will be performed on the most symptomatic lumbar iliocostalis muscle.

Diathermy treatment

Diathermy treatment will be applied using the TCaRe Power diathermy instrument (PRIM Physio©), using a capacitive system with an intensity of 50%, with slight variation depending on patient tolerance and 500khz. The therapy will be applied for 10 minutes on each side of the patient's lumbar region, who will be positioned in prone decubitus during the intervention.

Patients will complete a home exercise program

Group Type: EXPERIMENTAL

Tecartherapy treatment

Intervention Type: OTHER

Treatment will be carried out with deep thermotherapy in the lumbar region.

Interventions

Dry needling

Invasive treatment will be performed on the most symptomatic lumbar iliocostalis muscle.

Intervention Type: OTHER

Tecartherapy treatment

Treatment will be carried out with deep thermotherapy in the lumbar region.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 65 years.
• Chronic non-specific low back pain.
• Duration of pain of more than 6 weeks.

Exclusion Criteria

• Neurological signs or symptoms.
• Radicular pain.
• Radiating pain below the knee.
• Belonephobia.
• Traumatic processes and/or surgeries in the lumbar region in the last year.
• Having received physiotherapy treatment in the last 3 months.
• Systemic diseases such as cancer, rheumatic diseases, neurological diseases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Daniel Pecos Martín

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Pecos-Martín, PhD

Role: PRINCIPAL_INVESTIGATOR

Alcala University

Locations

Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Patricia M Martínez - Merinero, PhD

Role: CONTACT

info@institutofisioterapiaydolor.es

+34683378391

Facility Contacts

Patricia Martinez-Merinero, PhD

Role: primary

info@institutofisioterapiaydolor.es

683378391

Laura Cabellos

Role: backup

l.cabellos@uah.es

683378391

Other Identifiers

CEIM/HU/2019/30

Identifier Type: -

Identifier Source: org_study_id