Dry Needlig Vesus Tecartherapy in Low-back Pain Treatment

April 27, 2026 updated by: Prof. Dr. Daniel Pecos Martín, University of Alcala

Effectiveness of Diathermy Compared to Dry Needling in the Short-term Management of Subjects With Chronic Low Back Pain: a Randomised Controlled Trial

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

60

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 Locations

  • Spain
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28805

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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
Experimental: 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
Other: Dry needling
Invasive treatment will be performed on the most symptomatic lumbar iliocostalis muscle.
Experimental: 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
Other: Tecartherapy treatment
Treatment will be carried out with deep thermotherapy in the lumbar region.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale
Time Frame: Change from baseline at 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rolland-Morris questionnaire
Time Frame: Change from baseline at 3 months
The questionnaire scores from 0 (no disability) to 24 (maximum degree of disability), its cross-cultural adaptation to Spanish has shown good concurrent validity values (r = 0.34-0.57) and good reliability values (Intraclass Correlation Coefficient = 0.87).
Change from baseline at 3 months
Tampa Scale for Kinesiophobia 11 (TSK-11)
Time Frame: Change from baseline at 3 months
The questionnaire is scored from 11 to 44, the score being represented as a percentage from 0% (minimum degree of kinesiophobia) to 100% (maximum degree of kinesiophobia). The cross-cultural adaptation of the TSK-11 to Spanish has shown good concurrent validity values (r = 0.27-0.49) and good reliability values (r = 0.55).
Change from baseline at 3 months
Pain Catastrophism Scale
Time Frame: Change from baseline at 3 months
The questionnaire is scored from 0 to 54 and is represented as a percentage from 0% (minimum degree of catastrophism) to 100% (maximum degree of catastrophism). The cross-cultural adaptation to Spanish has shown good values of concurrent validity (r = 0.28-0.66) and reliability (Intraclass Correlation Coefficient = 0.84).
Change from baseline at 3 months
Pressure pain threshold
Time Frame: Change from baseline at 3 months
The pressure pain threshold (PPT) will be measured using a hand-held algometer (Wagner Force Dial, Model FDK 20, Wargner Instruments, Greenwich, CT, USA). This algometer has a 1cm2 surface area tip that records the pressure in kg/cm2. The algometer has been shown to be a valid and reliable tool for the measurement of UDP, with Intraclass Correlation Coefficient values in subjects with low back pain of 0.93.
Change from baseline at 3 months

Collaborators and Investigators

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

Sponsor

University of Alcala

Investigators

  • Principal Investigator: Daniel Pecos-Martin, PhD, Alcalá University

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 (Actual)

June 20, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (Actual)

June 16, 2022

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIM/HU/2019/30

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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