Clinical trial NCT04804228: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Electrical dry needling
low back pain
Randomized clinical trial
ischemic compression
analytical stretch
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in pressure pain threshold by Wagner manual pressure algometer.
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
timeFrame: At baseline, at 6 weeks and at 2 months
Secondary outcomes:
measure: Change from baselina in range of motion
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Change from baseline in lumbar mobility flexion.
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Changes in pressure pain threshold by Wagner manual pressure algometer.
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Tampa Scale of Kinesiophobia (TSK).Change from baseline in Fear of Movement.
timeFrame: At baseline, at 6 weeks and at 2 months
measure: SF-36 Health Questionnaire (SF-36).Change from baseline on Quality of Life.
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Change from Mcquade Test.
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Change from insomnia Severity Index Índice de calidad de sueño de Pittsburgh.
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Change from baseline in disability. Oswestry Low Back Pain Disability Idex.
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Change from baseline in pain intensity. Visual analogue scale
timeFrame: At baseline, at 6 weeks and at 2 months
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Adelaida María Castro-Sánchez
Study officials:
affiliation: Almeria University
name: Adelaida María Castro-Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Travell JG, Simons DG. Dolor y disfunción miofascial. El manual de los puntos gatillo. Volumen II. Extremidades inferiores. Madrid: Ed Panamericana. 2007.
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citation: 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.