Clinical trial NCT05422040: Dry Needlig Vesus Tecartherapy in Low-back Pain Treatment
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Back pain, dry needling, Tecartherapy
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Visual analogue scale
timeFrame: Change from baseline at 3 months
Secondary outcomes:
measure: Rolland-Morris questionnaire
timeFrame: Change from baseline at 3 months
measure: Tampa Scale for Kinesiophobia 11 (TSK-11)
timeFrame: Change from baseline at 3 months
measure: Pain Catastrophism Scale
timeFrame: Change from baseline at 3 months
measure: Pressure pain threshold
timeFrame: Change from baseline at 3 months
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Centro Investigación Fisioterapia y Dolor
state: Madrid
Study officials:
affiliation: Alcala University
name: Daniel Pecos-Martín, PhD
role: PRINCIPAL_INVESTIGATOR
References: