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Dry Needlig Vesus Tecartherapy in Low-back Pain Treatment

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Tecartherapy treatment
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Back pain, dry needling, Tecartherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro Investigación Fisioterapia y DolorRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dry needling

Diathermy treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Rolland-Morris questionnaire
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).
Tampa Scale for Kinesiophobia 11 (TSK-11)
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).
Pain Catastrophism Scale
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).
Pressure pain threshold
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.

Full Information

First Posted
June 13, 2022
Last Updated
August 24, 2023
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT05422040
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Back pain, dry needling, Tecartherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dry needling
Arm Type
Experimental
Arm Description
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.
Arm Title
Diathermy treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
Invasive treatment will be performed on the most symptomatic lumbar iliocostalis muscle.
Intervention Type
Other
Intervention Name(s)
Tecartherapy treatment
Intervention Description
Treatment will be carried out with deep thermotherapy in the lumbar region.
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
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).
Time Frame
Change from baseline at 3 months
Secondary Outcome Measure Information:
Title
Rolland-Morris questionnaire
Description
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).
Time Frame
Change from baseline at 3 months
Title
Tampa Scale for Kinesiophobia 11 (TSK-11)
Description
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).
Time Frame
Change from baseline at 3 months
Title
Pain Catastrophism Scale
Description
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).
Time Frame
Change from baseline at 3 months
Title
Pressure pain threshold
Description
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.
Time Frame
Change from baseline at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia M Martínez - Merinero, PhD
Phone
+34683378391
Email
info@institutofisioterapiaydolor.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Pecos-Martín, PhD
Organizational Affiliation
Alcala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Investigación Fisioterapia y Dolor
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Martinez-Merinero, PhD
Phone
683378391
Email
info@institutofisioterapiaydolor.es
First Name & Middle Initial & Last Name & Degree
Laura Cabellos
Phone
683378391
Email
l.cabellos@uah.es

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dry Needlig Vesus Tecartherapy in Low-back Pain Treatment

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