Low Back PainNCT05422040
Dry Needlig Vesus Tecartherapy in Low-back Pain Treatment
A study testing Dry needling and Tecartherapy treatment in people with Low Back Pain, run by University of Alcala at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Dry needling and Tecartherapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jun 2022to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years.
- Chronic non-specific low back pain.
- Duration of pain of more than 6 weeks.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Centro Investigación Fisioterapia y Dolor
Alcalá de Henares, Madrid, 28805
Patricia Martinez-Merinero, PhD, 683378391, info@institutofisioterapiaydolor.es
Laura Cabellos, 683378391, l.cabellos@uah.es
About this study
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
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).
Read the 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
- Conditions
- Low Back Pain
- Being tested
- Dry needling, Tecartherapy treatment
- Keywords
- Back pain, dry needling, Tecartherapy
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
Invasive treatment will be performed on the most symptomatic lumbar iliocostalis muscle.
Tecartherapy treatmentOther
Treatment will be carried out with deep thermotherapy in the lumbar region.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Tecartherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline at 3 months
Secondary outcomes (4)
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).
Measured: Change from baseline at 3 months
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).
Measured: Change from baseline at 3 months
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).
Measured: Change from baseline at 3 months
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.
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start20 Jun 2022
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Daniel Pecos-Martín, PhD, Principal investigator, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422040
- Sponsor's protocol ID
- CEIM/HU/2019/30
- Status last verified
- Apr 2026
- First submitted
- 13 Jun 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05422040
- Acronym / sponsor ID
- CEIM/HU/2019/30
- Conditions
- Low Back Pain
- Keywords
- Back pain, dry needling, Tecartherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry needlingDry 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 |
| Diathermy treatment | Experimental | Other: Tecartherapy treatmentDiathermy 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years.
- Chronic non-specific low back pain.
- Duration of pain of more than 6 weeks.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry needlingInvasive treatment will be performed on the most symptomatic lumbar iliocostalis muscle. | Other | Dry needling |
| Tecartherapy treatmentTreatment will be carried out with deep thermotherapy in the lumbar region. | Other | Diathermy treatment |
Primary outcome
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).
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Pecos-Martín, PhD principal investigator
Alcala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling and Tecartherapy treatment in people with Low Back Pain, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia M Martínez - Merinero, PhD (+34683378391, info@institutofisioterapiaydolor.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: Change from baseline at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.