Dry Needling Versus Percutaneous Electrolysis in Lumbar Multifidus Muscles in Patients With Chronic Low Back Pain.

NCT ID: NCT06505161

Last Updated: 2024-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-07-01

Brief Summary

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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

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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

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Chronic Low-back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
40 sealed opaque envelopes will be prepared. 20 of the envelopes will contain ballots corresponding to the DN control group and 20 to the PE group. Only the examiner who will carry out the intervention will know the group of each participant. The main examiner will be the one who monitors the intervention without knowing which group each participant belongs to.

Study Groups

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Dry needling group

The dry needling group will recibe a dry needling treatment with the Hong technique.

Group Type ACTIVE_COMPARATOR

Dry needling

Intervention Type OTHER

It consists in application of dry needling on active and/or latent TPs in low back multifidus muscles

Percutaneous electrolysis group

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.

Group Type EXPERIMENTAL

Percutaneous electrolysis

Intervention Type OTHER

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.

Interventions

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Dry needling

It consists in application of dry needling on active and/or latent TPs in low back multifidus muscles

Intervention Type OTHER

Percutaneous electrolysis

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Low back pain ≥ 3 months.
* Age between 30 and 60 years old.
* Not being receiving other physical therapy

Exclusion Criteria

* 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.
* Pacemaker.
* Pregnancy.
* Patients with neurological pathology
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alcala

OTHER

Sponsor Role lead

Responsible Party

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Leire López de Calle Sánchez

Leire López de Calle Sánchez

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leire Lopez de Calle Sánchez, Grade

Role: PRINCIPAL_INVESTIGATOR

University of Alcala

Samuel Fernandez Carnero, PhD

Role: STUDY_DIRECTOR

University of Alcala

Locations

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Campus Científico-Tecnológico UAH. Av. de León, 3A

Alcalá de Henares, Madrid, Spain

Site Status

Countries

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Spain

Central Contacts

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Leire Lopez de Calle Sánchez, Grade

Role: CONTACT

+34661620517

Samuel Fernandez Carnero, PhD

Role: CONTACT

Facility Contacts

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Leire López de Calle Sánchez, Grade

Role: primary

+34661620517

References

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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.

Reference Type BACKGROUND
PMID: 28719509 (View on PubMed)

Chou 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.

Reference Type BACKGROUND
PMID: 17909209 (View on PubMed)

Matheve 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.

Reference Type BACKGROUND
PMID: 37685576 (View on PubMed)

Hodges 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.

Reference Type BACKGROUND
PMID: 31151377 (View on PubMed)

Hu 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.

Reference Type BACKGROUND
PMID: 29952980 (View on PubMed)

Fakontis 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.

Reference Type BACKGROUND
PMID: 37458028 (View on PubMed)

Valera-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.

Reference Type BACKGROUND
PMID: 34754834 (View on PubMed)

Other Identifiers

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Dry needling Electrolysis

Identifier Type: -

Identifier Source: org_study_id

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