Chronic Low-back PainDN-PE-LBPNCT06505161
Dry Needling Versus Percutaneous Electrolysis in Lumbar Multifidus Muscles in Patients With Chronic Low Back Pain.
A study testing Dry needling and Percutaneous electrolysis in people with Chronic Low-back Pain, run by University of Alcala at 1 site in Spain.
Trial summary
The aim of this study is to evaluate the reduction of pain of two different treatments in patients with chronic low back pain. Patients were divided in two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Dry needling and Percutaneous electrolysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Low back pain ≥ 3 months.
- Age between 30 and 60 years old.
- Not being receiving other physical therapy
Who cannot join
- Diagnosis of specific lumbar pathology.
- History of previous lumbar surgery.
- Treatment with corticosteroids, anti-inflammatory or antibiotic medication in recent weeks.
- Oncological processes, febrile symptoms or thrombophlebitis.
- Skin conditions.
- Belonephobia.
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- Pacemaker.
- Pregnancy.
- Patients with neurological pathology
Trial locations and contacts
1 site in 1 country.
Samuel Fernandez Carnero, PhD contact
Spain1 site
Campus Científico-Tecnológico UAH. Av. de León, 3A
Alcalá de Henares, Madrid, 28805
Leire López de Calle Sánchez, Grade, +34661620517, leire.lopezc@edu.uah.es
About this study
Official title: Dry Needling Versus Percutaneous Electrolysis in Lumbar Multifidus Muscles in Patients With Chronic Low Back Pain
The aim of this study is to evaluate the reduction of pain of two different treatments in patients with chronic low back pain. Patients were divided in two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles.
Read the detailed description
Background: Low back pain is one of the most common health problems and a leading cause of disability and absence from work. Between 70% and 80% of adults will experience an episode of low back pain and approximately 10.0% of them will become chronic. This has a direct impact on the lumbar stabilizing muscles, giving rise to both structural and functional changes. Among the different treatment options, it has been observed that both dry needling (DN) and percutaneous electrolysis (PE) are effective techniques in the management of musculoskeletal pain.
Aim: To evaluate whether the reduction of pain after the application of PE is superior to the one obtained with DN.
Methods: A single-blind randomized clinical trial will be conducted in patients with chronic low back pain. The subjects will be divided into two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles. The study variables will be: pain (VAS), disability index (Oswestry Scale), fear of movement (TSK-11SV) and quality of life (SF-12). The measurements will be assessed before, right after and 7 days after a single intervention.
- Conditions
- Chronic Low-back Pain
- Being tested
- Dry needling, Percutaneous electrolysis
- Keywords
- chronic low back pain, Dry needling, Percutaneous electrolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
It consists in application of dry needling on active and/or latent TPs in low back multifidus muscles
Percutaneous electrolysisOther
It consists in the application of intratissue percutaneous electrolysis with galvanic current as a cathodic flow electrode in the low back multifidus muscles. The intervention will be guided by ultrasound equipment medically certified.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling group | Active comparator | The dry needling group will recibe a dry needling treatment with the Hong technique. Receives: Other: Dry needling |
| Percutaneous electrolysis group | Experimental | The percutaneous electrolysis grupos will recibe a tratement of galvanic current at 1.5mA, with 3-5 impacts, for 3-5 seconds in the low back multifiud muscles. Receives: Other: Percutaneous electrolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity. Visual analogue scale.
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain
Measured: At baseline, at 1 week after the last intervention, and 6-month follow-up period
Secondary outcomes (3)
Disability. Oswestry Low Back Pain Disability Idex
It has 10 items associated to activities of daily living, each item has a punctuation from 0 to 5 points
Measured: At baseline, at 1 week after the last intervention, and 6-month follow-up period
Fear of Movement. Tampa Scale of kinesiophobia (TSK-11SV)
Is a 11-item questionnaire that measures the fear of movement and (re)injury.
Measured: At baseline, at 1 week after the last intervention, and 6-month follow-up period
Quality of life. SF-12 Health questionnaire.
SF-12 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life
Measured: At baseline, at 1 week after the last intervention, and 6-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Model description
- The subjects will be divided into two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leire López de Calle Sánchez, University of Alcala
- Investigators
- Leire Lopez de Calle Sánchez, Grade, Principal investigator, University of AlcalaSamuel Fernandez Carnero, PhD, Study director, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505161
- Sponsor's protocol ID
- Dry needling Electrolysis
- Acronym
- DN-PE-LBP
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ng SK, Urquhart DM, Fitzgerald PB, Cicuttini FM, Hussain SM, Fitzgibbon BM. The Relationship Between Structural and Functional Brain Changes and Altered Emotion and Cognition in Chronic Low Back Pain Brain Changes: A Systematic Review of MRI and fMRI Studies. Clin J Pain. 2018 Mar;34(3):237-261. doi: 10.1097/AJP.0000000000000534.
PubMed 28719509Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.
PubMed 17909209Matheve T, Hodges P, Danneels L. The Role of Back Muscle Dysfunctions in Chronic Low Back Pain: State-of-the-Art and Clinical Implications. J Clin Med. 2023 Aug 24;12(17):5510. doi: 10.3390/jcm12175510.
PubMed 37685576Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827.
PubMed 31151377Hu HT, Gao H, Ma RJ, Zhao XF, Tian HF, Li L. Is dry needling effective for low back pain?: A systematic review and PRISMA-compliant meta-analysis. Medicine (Baltimore). 2018 Jun;97(26):e11225. doi: 10.1097/MD.0000000000011225.
PubMed 29952980Fakontis C, Iakovidis P, Lytras D, Kasimis K, Koutras G, Ntinou SR, Kottaras A, Chatziprodromidou IP, Chatzikonstantinou P, Apostolou T. Efficacy of percutaneous needle electrolysis versus dry needling in musculoskeletal pain: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2023;36(5):1033-1046. doi: 10.3233/BMR-220408.
PubMed 37458028Valera-Calero JA, Sanchez-Mayoral-Martin A, Varol U. Short-term effectiveness of high- and low-intensity percutaneous electrolysis in patients with patellofemoral pain syndrome: A pilot study. World J Orthop. 2021 Oct 18;12(10):781-790. doi: 10.5312/wjo.v12.i10.781. eCollection 2021 Oct 18.
PubMed 34754834
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling Versus Percutaneous Electrolysis in Lumbar Multifidus Muscles in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06505161
- Acronym / sponsor ID
- DN-PE-LBP / Dry needling Electrolysis
- Conditions
- Chronic Low-back Pain
- Keywords
- chronic low back pain, Dry needling, Percutaneous electrolysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 17 Jul 2024 (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.
The aim of this study is to evaluate the reduction of pain of two different treatments in patients with chronic low back pain. Patients were divided in two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles.
Detailed description
Background: Low back pain is one of the most common health problems and a leading cause of disability and absence from work. Between 70% and 80% of adults will experience an episode of low back pain and approximately 10.0% of them will become chronic. This has a direct impact on the lumbar stabilizing muscles, giving rise to both structural and functional changes. Among the different treatment options, it has been observed that both dry needling (DN) and percutaneous electrolysis (PE) are effective techniques in the management of musculoskeletal pain.
Aim: To evaluate whether the reduction of pain after the application of PE is superior to the one obtained with DN.
Methods: A single-blind randomized clinical trial will be conducted in patients with chronic low back pain. The subjects will be divided into two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles. The study variables will be: pain (VAS), disability index (Oswestry Scale), fear of movement (TSK-11SV) and quality of life (SF-12). The measurements will be assessed before, right after and 7 days after a single intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The subjects will be divided into two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles.
| Arm | Type | Receives |
|---|---|---|
| Dry needling group | Active comparator | Other: Dry needlingThe dry needling group will recibe a dry needling treatment with the Hong technique. |
| Percutaneous electrolysis group | Experimental | Other: Percutaneous electrolysisThe percutaneous electrolysis grupos will recibe a tratement of galvanic current at 1.5mA, with 3-5 impacts, for 3-5 seconds in the low back multifiud muscles. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Low back pain ≥ 3 months.
- Age between 30 and 60 years old.
- Not being receiving other physical therapy
Key exclusion criteria (9 listed)
- Diagnosis of specific lumbar pathology.
- History of previous lumbar surgery.
- Treatment with corticosteroids, anti-inflammatory or antibiotic medication in recent weeks.
- Oncological processes, febrile symptoms or thrombophlebitis.
- Skin conditions.
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 needlingIt consists in application of dry needling on active and/or latent TPs in low back multifidus muscles | Other | Dry needling group |
| Percutaneous electrolysisIt consists in the application of intratissue percutaneous electrolysis with galvanic current as a cathodic flow electrode in the low back multifidus muscles. The intervention will be guided by ultrasound equipment medically certified. | Other | Percutaneous electrolysis group |
Primary outcome
Pain intensity. Visual analogue scale.
Time frame: At baseline, at 1 week after the last intervention, and 6-month follow-up period
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain
3 secondary outcomes
Disability. Oswestry Low Back Pain Disability Idex
Time frame: At baseline, at 1 week after the last intervention, and 6-month follow-up period
Fear of Movement. Tampa Scale of kinesiophobia (TSK-11SV)
Time frame: At baseline, at 1 week after the last intervention, and 6-month follow-up period
Quality of life. SF-12 Health questionnaire.
Time frame: At baseline, at 1 week after the last intervention, and 6-month follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Background: PubMed 28719509Ng SK, Urquhart DM, Fitzgerald PB, Cicuttini FM, Hussain SM, Fitzgibbon BM. The Relationship Between Structural and Functional Brain Changes and Altered Emotion and Cognition in Chronic Low Back Pain Brain Changes: A Systematic Review of MRI and fMRI Studies. Clin J Pain. 2018 Mar;34(3):237-261. doi: 10.1097/AJP.0000000000000534.
- Background: PubMed 17909209Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK; Clinical Efficacy Assessment Subcommittee of the American College of Physicians; American College of Physicians; American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. doi: 10.7326/0003-4819-147-7-200710020-00006.
- Background: PubMed 37685576Matheve T, Hodges P, Danneels L. The Role of Back Muscle Dysfunctions in Chronic Low Back Pain: State-of-the-Art and Clinical Implications. J Clin Med. 2023 Aug 24;12(17):5510. doi: 10.3390/jcm12175510.
- Background: PubMed 31151377Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827.
- Background: PubMed 29952980Hu HT, Gao H, Ma RJ, Zhao XF, Tian HF, Li L. Is dry needling effective for low back pain?: A systematic review and PRISMA-compliant meta-analysis. Medicine (Baltimore). 2018 Jun;97(26):e11225. doi: 10.1097/MD.0000000000011225.
- Background: PubMed 37458028Fakontis C, Iakovidis P, Lytras D, Kasimis K, Koutras G, Ntinou SR, Kottaras A, Chatziprodromidou IP, Chatzikonstantinou P, Apostolou T. Efficacy of percutaneous needle electrolysis versus dry needling in musculoskeletal pain: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2023;36(5):1033-1046. doi: 10.3233/BMR-220408.
- Background: PubMed 34754834Valera-Calero JA, Sanchez-Mayoral-Martin A, Varol U. Short-term effectiveness of high- and low-intensity percutaneous electrolysis in patients with patellofemoral pain syndrome: A pilot study. World J Orthop. 2021 Oct 18;12(10):781-790. doi: 10.5312/wjo.v12.i10.781. eCollection 2021 Oct 18.
- 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. This study is not recruiting at the moment.
Samuel Fernandez Carnero, PhD contact
Leire Lopez de Calle Sánchez, Grade principal investigator
University of Alcala
Samuel Fernandez Carnero, PhD study director
University of Alcala
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 Percutaneous electrolysis in people with Chronic 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 9 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: status not confirmed, as of the sponsor's last update on 17 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leire Lopez de Calle Sánchez, Grade (+34661620517, leire.lopezc@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity. Visual analogue scale. (time frame: At baseline, at 1 week after the last intervention, and 6-month follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06505161, which also lists 7 linked publications.
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 17 Jul 2024.