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

Not Applicable

Completed

• Conditions: Chronic Low-back Pain
• Interventions: Other: Ischemic compression, analytical stretching and postural habits educational dossier; Other: Electrical dry needling

• Registration Number: NCT04804228
• Lead Sponsor: Universidad de Almeria

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.

Study Timeline

• Study Start: 2020-05-17
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-18
• Primary Completion: 2021-08-17
• Status Verified: 2021-11
• Study Completion: 2021-11-20
• Last Update Submitted: 2021-11-26
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrical dry needling	Ischemic compression, analytical stretching and postural habits educational dossier	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.
Ischemic compression, analytical stretching and postural habits educational dossier	Electrical dry needling	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.

Primary Outcome Measures

Name	Time	Method
Changes in pressure pain threshold by Wagner manual pressure algometer.	At baseline, at 6 weeks and at 2 months	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).	At baseline, at 6 weeks and at 2 months	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

Name	Time	Method
Change from baselina in range of motion	At baseline, at 6 weeks and at 2 months	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.
SF-36 Health Questionnaire (SF-36).Change from baseline on Quality of Life.	At baseline, at 6 weeks and at 2 months	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)
Changes in pressure pain threshold by Wagner manual pressure algometer.	At baseline, at 6 weeks and at 2 months	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 Mcquade Test.	At baseline, at 6 weeks and at 2 months	It measures the isometric endurance of trunk flexion muscles.
Tampa Scale of Kinesiophobia (TSK).Change from baseline in Fear of Movement.	At baseline, at 6 weeks and at 2 months	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).
Change from baseline in pain intensity. Visual analogue scale	At baseline, at 6 weeks and at 2 months	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
Change from insomnia Severity Index Índice de calidad de sueño de Pittsburgh.	At baseline, at 6 weeks and at 2 months	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.	At baseline, at 6 weeks and at 2 months	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 lumbar mobility flexion.	At baseline, at 6 weeks and at 2 months	For the quantification of lumbar flexion an angular inclinometer is used (Fleximeter UM 8320-3 RJ Code Research Institute, Brazil).

Trial Locations

Locations (1)

Adelaida María Castro-Sánchez; 🇪🇸 Almería, Spain