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

NCT06505161 | Not Yet Recruiting

• 1 other identifier: Dry needling Electrolysis
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low-back Pain

Keywords

chronic low back pain; Dry needling; Percutaneous electrolysis

Outcome Measures

Primary Outcomes (1)

• Pain intensity. Visual analogue scale.

  A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain

  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

  At baseline, at 1 week after the last intervention, and 6-month follow-up period

• Fear of Movement. Tampa Scale of kinesiophobia (TSK-11SV)

  At baseline, at 1 week after the last intervention, and 6-month follow-up period

• Quality of life. SF-12 Health questionnaire.

  At baseline, at 1 week after the last intervention, and 6-month follow-up period

Study Arms (2)

Dry needling group

ACTIVE COMPARATOR

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

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.

Other: Percutaneous electrolysis

Interventions

Dry needling OTHER

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

Dry needling group

Percutaneous electrolysis 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.

Percutaneous electrolysis group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

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

Alcalá de Henares, Madrid, 28805, Spain

Location

Related Publications (7)

• 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.

  PMID: 28719509 BACKGROUND

• 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.

  PMID: 17909209 BACKGROUND

• 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.

  PMID: 37685576 BACKGROUND

• 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.

  PMID: 31151377 BACKGROUND

• 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.

  PMID: 29952980 BACKGROUND

• 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.

  PMID: 37458028 BACKGROUND

• 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.

  PMID: 34754834 BACKGROUND

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Leire Lopez de Calle Sánchez, Grade

  University of Alcala

  PRINCIPAL INVESTIGATOR

• Samuel Fernandez Carnero, PhD

  University of Alcala

  STUDY DIRECTOR

Central Study Contacts

Leire Lopez de Calle Sánchez, Grade

CONTACT

+34661620517; leire.lopezc@edu.uah.es

Samuel Fernandez Carnero, PhD

CONTACT

samuel.fernandezc@uah.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leire López de Calle Sánchez

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: September 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)