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

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Electrical dry needling
Ischemic compression, analytical stretching and postural habits educational dossier
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Electrical dry needling, low back pain, Randomized clinical trial, ischemic compression, analytical stretch

Eligibility Criteria

30 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Adelaida María Castro-Sánchez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electrical dry needling

Ischemic compression, analytical stretching and postural habits educational dossier

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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

Secondary Outcome Measures

Change from baselina in range of motion
This variable is quantified using the SpinalMouse ® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagittal spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way.
Change from baseline in lumbar mobility flexion.
For the quantification of lumbar flexion an angular inclinometer is used (Fleximeter UM 8320-3 RJ Code Research Institute, Brazil).
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).
Tampa Scale of Kinesiophobia (TSK).Change from baseline in Fear of Movement.
Is a 17-item questionnaire that measures the fear of movement and (re)injury.Patient rate beliefs about their pain on a 4-point scale ranging from strongly disagree to strongly agree (ranging from 17-68 points).
SF-36 Health Questionnaire (SF-36).Change from baseline on Quality of Life.
The SF-36 quality of life questionnaire assesses 8 domains including physical functioning, physical role, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. This scale ranges from 0 (lowest level of functioning) to 100 (highest level)
Change from Mcquade Test.
It measures the isometric endurance of trunk flexion muscles.
Change from insomnia Severity Index Índice de calidad de sueño de Pittsburgh.
This questionnaire consists of 24 questions. The total score can range from 0 to 21 points. The higher the total score, the worse the quality of sleep.
Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
It has 10 items associated to activities of daily living, each ítem has a puntuation fron 0 to 5 points.The higher scores mean a worse outcome.
Change from baseline in pain intensity. Visual analogue scale
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain. Range from no pain 0 to maximum pain 10 points

Full Information

First Posted
January 14, 2021
Last Updated
November 26, 2021
Sponsor
Universidad de Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT04804228
Brief Title
Efficacy of Electrical Dry Needling in Pain, Sensitivity, Functionality and Quality of Life of Patients With Chronic Non-specific Low Back Pain
Official Title
Comparison of the Efficacy of Electrical Dry Needling Versus Traditional Physical Therapy in the Treatment of Active Myofascial Trigger Points in Pain, Sensitivity, Functionality and Quality of Life of Patients With Chronic Non-specific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 17, 2020 (Actual)
Primary Completion Date
August 17, 2021 (Actual)
Study Completion Date
November 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
A double-blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients in the experimental group will receive electrical dry needling at the active myofascial trigger points (PGM) of the quadratus lumbar, multifidus, and iliocostal muscles (following the PGM maps described by Travell and Simons). The technique will be performed 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, during 30 min of application. The therapeutic intervention will be 1 weekly session for a total of 6 weeks. The control group 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. The treatment will consist of 1 weekly session for 6 weeks, in addition they will be provided with a training dossier on postural education in their activities of daily life. A baseline assessment of the primary and secondary outcome measures will be carried out before randomization of the participants to the different groups, an immediate post-treatment assessment (1 day after the last intervention) and an assessment two month after the end of the intervention ( short-term follow-up). The objectives of this study are to compare the repercussions of dry electropuncture versus ischemic compression in active PGM plus stretching in terms of pain, functionality, mobility of the spine, and quality of life in patients with non-specific chronic low back pain; and analyze the impact on active myofascial trigger points in terms of pressure tolerance threshold.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Electrical dry needling, low back pain, Randomized clinical trial, ischemic compression, analytical stretch

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical dry needling
Arm Type
Experimental
Arm Description
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.
Arm Title
Ischemic compression, analytical stretching and postural habits educational dossier
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Electrical dry needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Ischemic compression, analytical stretching and postural habits educational dossier
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in pressure pain threshold by Wagner manual pressure algometer.
Description
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).
Time Frame
At baseline, at 6 weeks and at 2 months
Title
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
Description
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
Time Frame
At baseline, at 6 weeks and at 2 months
Secondary Outcome Measure Information:
Title
Change from baselina in range of motion
Description
This variable is quantified using the SpinalMouse ® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagittal spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way.
Time Frame
At baseline, at 6 weeks and at 2 months
Title
Change from baseline in lumbar mobility flexion.
Description
For the quantification of lumbar flexion an angular inclinometer is used (Fleximeter UM 8320-3 RJ Code Research Institute, Brazil).
Time Frame
At baseline, at 6 weeks and at 2 months
Title
Changes in pressure pain threshold by Wagner manual pressure algometer.
Description
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).
Time Frame
At baseline, at 6 weeks and at 2 months
Title
Tampa Scale of Kinesiophobia (TSK).Change from baseline in Fear of Movement.
Description
Is a 17-item questionnaire that measures the fear of movement and (re)injury.Patient rate beliefs about their pain on a 4-point scale ranging from strongly disagree to strongly agree (ranging from 17-68 points).
Time Frame
At baseline, at 6 weeks and at 2 months
Title
SF-36 Health Questionnaire (SF-36).Change from baseline on Quality of Life.
Description
The SF-36 quality of life questionnaire assesses 8 domains including physical functioning, physical role, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. This scale ranges from 0 (lowest level of functioning) to 100 (highest level)
Time Frame
At baseline, at 6 weeks and at 2 months
Title
Change from Mcquade Test.
Description
It measures the isometric endurance of trunk flexion muscles.
Time Frame
At baseline, at 6 weeks and at 2 months
Title
Change from insomnia Severity Index Índice de calidad de sueño de Pittsburgh.
Description
This questionnaire consists of 24 questions. The total score can range from 0 to 21 points. The higher the total score, the worse the quality of sleep.
Time Frame
At baseline, at 6 weeks and at 2 months
Title
Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
Description
It has 10 items associated to activities of daily living, each ítem has a puntuation fron 0 to 5 points.The higher scores mean a worse outcome.
Time Frame
At baseline, at 6 weeks and at 2 months
Title
Change from baseline in pain intensity. Visual analogue scale
Description
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain. Range from no pain 0 to maximum pain 10 points
Time Frame
At baseline, at 6 weeks and at 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Low back pain ≥ 3 months. Age between 30 and 67 years old. Not being receiving physical therapy. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelaida María Castro-Sánchez, PhD
Organizational Affiliation
Almeria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adelaida María Castro-Sánchez
City
Almería
ZIP/Postal Code
04120
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26475933
Citation
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.
Results Reference
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Citation
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.
Results Reference
background
Citation
Travell JG, Simons DG. Dolor y disfunción miofascial. El manual de los puntos gatillo. Volumen II. Extremidades inferiores. Madrid: Ed Panamericana. 2007.
Results Reference
background
PubMed Identifier
29864043
Citation
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.
Results Reference
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PubMed Identifier
30379937
Citation
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.
Results Reference
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PubMed Identifier
31354339
Citation
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.
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PubMed Identifier
32610659
Citation
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.
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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. Erratum In: Spine J. 2021 May 22;:
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Results Reference
derived

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

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