Efficacy of Electrical Dry Needling in Pain, Sensitivity, Functionality and Quality of Life of Patients With Chronic Non-specific Low Back Pain

NCT04804228 | Completed

• 1 other identifier: EFM 87/2020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to determine the efficacy of electrical dry needling versus ischemic compression, analytical stretching and postural habits educational dossier in active myofascial trigger points in patients with chronic non-specific low back pain.

Conditions

Chronic Low-back Pain

Keywords

Electrical dry needling; low back pain; Randomized clinical trial; ischemic compression; analytical stretch

Outcome Measures

Primary Outcomes (2)

• Changes in pressure pain threshold by Wagner manual pressure algometer.

  Apply the tip of the algometer perpendicular to the muscle and maintain a pressure, which will gradually increase to 1 kg / sec. Subjects will be instructed to signal the moment they experience pain, in order to have an accurate record (pain threshold).

  At baseline, at 6 weeks and at 2 months

• Change from baseline in Roland Morris Disability Questionnaire (RMDQ).

  This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.Ranging from 0 points- better to 24 points- worse disability

  At baseline, at 6 weeks and at 2 months

Secondary Outcomes (9)

• Change from baselina in range of motion

  At baseline, at 6 weeks and at 2 months

• Change from baseline in lumbar mobility flexion.

  At baseline, at 6 weeks and at 2 months

• Changes in pressure pain threshold by Wagner manual pressure algometer.

  At baseline, at 6 weeks and at 2 months

• Tampa Scale of Kinesiophobia (TSK).Change from baseline in Fear of Movement.

  At baseline, at 6 weeks and at 2 months

• SF-36 Health Questionnaire (SF-36).Change from baseline on Quality of Life.

  At baseline, at 6 weeks and at 2 months

Study Arms (2)

Electrical dry needling

EXPERIMENTAL

The experimental group consisting of 40 subjects will perform electrostimulation on the active myofascial trigger points of the following muscles: quadratus lumbar, multifidus and iliocostalis, following the PGM maps described by Travell and Simons. The electrostimulation of the PGM will be carried out using needle electrodes, the generated current will be produced by a TENS device with a frequency of 2 Hz and a pulse width of 250 μs, the application will be approximately 30 min. The therapeutic intervention will be 1 session per week for a total of 6 weeks.

Other: Ischemic compression, analytical stretching and postural habits educational dossier

Ischemic compression, analytical stretching and postural habits educational dossier

ACTIVE COMPARATOR

The control group consisting of 40 subjects will undergo an ischemic compression technique in active PGM with a time between 20 seconds and 1 minute until pain inhibition is achieved, and finally, analytical stretching will be carried out on the quadratus lumbar, multifid and iliocostal, 1 weekly session for 6 weeks providing a training dossier of postural education in their activities of daily life.

Other: Electrical dry needling

Interventions

Electrical dry needling OTHER

The experimental group consisting of 40 subjects will perform electrostimulation on the active myofascial trigger points of the following muscles: quadratus lumbar, multifidus and iliocostalis. The electrostimulation of the PGM will be carried out using needle electrodes, the generated current will be produced by a TENS device with a frequency of 2 Hz and a pulse width of 250 μs, the application will be approximately 30 min. The therapeutic intervention will be 1 session per week for a total of 6 weeks.

Ischemic compression, analytical stretching and postural habits educational dossier

Ischemic compression, analytical stretching and postural habits educational dossier OTHER

The control group G2, formed by 40 subjects, will perform an ischemic compression technique in active PGM with a time between 20 seconds and 1 minute until pain inhibition is achieved, and finally, analytical stretching will be carried out on the quadratus lumbar, multifidus and iliocostal muscles, 1 weekly session for 6 weeks, in addition to providing them with a training dossier on postural education in their activities of daily life.

Electrical dry needling

Eligibility Criteria

• Age: 30 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low back pain ≥ 3 months.
• Age between 30 and 67 years old.
• Not being receiving physical therapy.

You may not qualify if:

• Presence of lumbar stenosis.
• Diagnosis of spondylolisthesis.
• Diagnosis of fibromyalgia.
• Treatment with corticosteroids or oral medication in recent weeks.
• History of spine surgery.
• Contraindication of analgesic electrical therapy.
• Have previously received a treatment of electrical analgesia or exercise.
• Central or peripheral nervous system disease.

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Adelaida María Castro-Sánchez

Almería, 04120, Spain

Location

Related Publications (12)

• Chiarotto A, Clijsen R, Fernandez-de-Las-Penas C, Barbero M. Prevalence of Myofascial Trigger Points in Spinal Disorders: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2016 Feb;97(2):316-37. doi: 10.1016/j.apmr.2015.09.021. Epub 2015 Oct 17.

  PMID: 26475933 BACKGROUND

• Travell JG, Simons DG, Simons LS. Dolor y disfunción miofascial. El manual de los puntos gatillo. Volumen I. Mitad superior del cuerpo. Madrid: Ed Panamericana. 2007.

  BACKGROUND

• Travell JG, Simons DG. Dolor y disfunción miofascial. El manual de los puntos gatillo. Volumen II. Extremidades inferiores. Madrid: Ed Panamericana. 2007.

  BACKGROUND

• Dunning J, Butts R, Young I, Mourad F, Galante V, Bliton P, Tanner M, Fernandez-de-Las-Penas C. Periosteal Electrical Dry Needling as an Adjunct to Exercise and Manual Therapy for Knee Osteoarthritis: A Multicenter Randomized Clinical Trial. Clin J Pain. 2018 Dec;34(12):1149-1158. doi: 10.1097/AJP.0000000000000634.

  PMID: 29864043 BACKGROUND

• Dunning J, Butts R, Henry N, Mourad F, Brannon A, Rodriguez H, Young I, Arias-Buria JL, Fernandez-de-Las-Penas C. Electrical dry needling as an adjunct to exercise, manual therapy and ultrasound for plantar fasciitis: A multi-center randomized clinical trial. PLoS One. 2018 Oct 31;13(10):e0205405. doi: 10.1371/journal.pone.0205405. eCollection 2018.

  PMID: 30379937 BACKGROUND

• Fernandez-de-Las-Penas C, Nijs J. Trigger point dry needling for the treatment of myofascial pain syndrome: current perspectives within a pain neuroscience paradigm. J Pain Res. 2019 Jun 18;12:1899-1911. doi: 10.2147/JPR.S154728. eCollection 2019.

  PMID: 31354339 BACKGROUND

• Rahou-El-Bachiri Y, Navarro-Santana MJ, Gomez-Chiguano GF, Cleland JA, Lopez-de-Uralde-Villanueva I, Fernandez-de-Las-Penas C, Ortega-Santiago R, Plaza-Manzano G. Effects of Trigger Point Dry Needling for the Management of Knee Pain Syndromes: A Systematic Review and Meta-Analysis. J Clin Med. 2020 Jun 29;9(7):2044. doi: 10.3390/jcm9072044.

  PMID: 32610659 BACKGROUND

• Dunning J, Butts R, Zacharko N, Fandry K, Young I, Wheeler K, Day J, Fernandez-de-Las-Penas C. Spinal manipulation and perineural electrical dry needling in patients with cervicogenic headache: a multicenter randomized clinical trial. Spine J. 2021 Feb;21(2):284-295. doi: 10.1016/j.spinee.2020.10.008. Epub 2020 Oct 13.

  PMID: 33065273 BACKGROUND

• Kumnerddee W, Pattapong N. Efficacy of electro-acupuncture in chronic plantar fasciitis: a randomized controlled trial. Am J Chin Med. 2012;40(6):1167-76. doi: 10.1142/S0192415X12500863.

  PMID: 23227789 BACKGROUND

• Myburgh C, Larsen AH, Hartvigsen J. A systematic, critical review of manual palpation for identifying myofascial trigger points: evidence and clinical significance. Arch Phys Med Rehabil. 2008 Jun;89(6):1169-76. doi: 10.1016/j.apmr.2007.12.033.

  PMID: 18503816 BACKGROUND

• Lara-Palomo IC, Antequera-Soler E, Fernandez-Sanchez M, Castro-Sanchez AM, Garcia-Lopez H. Electrical dry needling versus a non-invasive multicomponent intervention in the treatment of myofascial trigger points in patients with chronic low back pain: A randomised clinical trial. Clin Rehabil. 2024 Mar;38(3):347-360. doi: 10.1177/02692155231201589. Epub 2023 Sep 13.

  PMID: 37700695 DERIVED

• Lara-Palomo IC, Gil-Martinez E, Antequera-Soler E, Castro-Sanchez AM, Fernandez-Sanchez M, Garcia-Lopez H. Electrical dry needling versus conventional physiotherapy in the treatment of active and latent myofascial trigger points in patients with nonspecific chronic low back pain. Trials. 2022 Mar 28;23(1):238. doi: 10.1186/s13063-022-06179-y.

  PMID: 35346331 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Adelaida María Castro-Sánchez, PhD

  Almeria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: March 18, 2021
• Study Start: May 17, 2020
• Primary Completion: August 17, 2021
• Study Completion: November 20, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-11

Locations

ES (1)