Dry Needlig Vesus Tecartherapy in Low-back Pain Treatment

NCT05422040 | Recruiting

• 1 other identifier: CEIM/HU/2019/30
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Low Back Pain

Keywords

Back pain, dry needling, Tecartherapy

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale

  The visual analogue scale (VAS) is a 10cm long line where 0 indicates no pain at all and 10 the worst pain imaginable. It is a tool that has shown good reliability values (r = 0.94).

  Change from baseline at 3 months

Secondary Outcomes (4)

• Rolland-Morris questionnaire

  Change from baseline at 3 months

• Tampa Scale for Kinesiophobia 11 (TSK-11)

  Change from baseline at 3 months

• Pain Catastrophism Scale

  Change from baseline at 3 months

• Pressure pain threshold

  Change from baseline at 3 months

Study Arms (2)

Dry needling

EXPERIMENTAL

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

Other: Dry needling

Diathermy treatment

EXPERIMENTAL

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

Other: Tecartherapy treatment

Interventions

Dry needling OTHER

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

Dry needling

Tecartherapy treatment OTHER

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

Diathermy treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28805, Spain

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Back Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Daniel Pecos-Martín, PhD

  Alcala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia M Martínez - Merinero, PhD

CONTACT

+34683378391; info@institutofisioterapiaydolor.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: June 20, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)