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Recruiting NCT05422040

Dry Needlig Vesus Tecartherapy in Low-back Pain Treatment

No phase Interventional Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dry needling, Tecartherapy treatment.
Who it may be relevant to
Registry conditions: Low Back Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Visual analogue scale [Time frame: Change from baseline at 3 months]
Secondary outcome measures (4)
  • Rolland-Morris questionnaire [Time frame: Change from baseline at 3 months]
  • Tampa Scale for Kinesiophobia 11 (TSK-11) [Time frame: Change from baseline at 3 months]
  • Pain Catastrophism Scale [Time frame: Change from baseline at 3 months]
  • Pressure pain threshold [Time frame: Change from baseline at 3 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Centro Investigación Fisioterapia y Dolor — Alcalá de Henares

Identifiers

NCT: NCT05422040 · CEIM/HU/2019/30

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗