Short-term Effects of Exercise Program Versus Electropuncture in Patients With Chronic Non-specific Low Back Pain: A Randomized Clinical Trial.

Short-term Effects of Exercise Program Versus Electropuncture on Pain, Depression, Range of Motion and Disability, in Patients With Chronic Non-specific Low Back Pain: A Randomized Clinical Trial.

This study evaluate the effectiveness that exists when performing a treatment based on a table of exercises for strengthening the lumbar muscles versus a treatment based on electropuncture in patients with chronic low back pain.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Electroacupuncture; Exercise Program
• Intervention / Treatment: Other: Percutaneous electrostimulation treatment (EPS); Other: Exercise program

Detailed Description

Low back pain has a high prevalence in all European countries, appearing as the main cause of activity limitation in people under 45 years of age. It has got a high recurrence, which decreases the activities of daily life, facilitates the focus of attention to pain and increases the fear of movement, with the consequent muscular atrophy. A serie cases will be conducted comparing a a table of exercises versus electropuncture.

Objective: Evaluate the effectiveness that exists when performing a tratment based on a table of exercises for strengthening the lumbar muscles versus a treatment based on electropuncture.

Methods: A sample of 12 subjects with chronic low back pain will be assigned to an exercise program or dry electropuncture treatment (EPS), during 4 weeks (2 sessions/week). The measurement variables selected for the study were the followings: Straight Leg Raise, Vasalva, Gaesslen test, algometry (pressure pain threshold), goniometry (measurement of the range of motion), Scale of disability for low back pain of Oswestry, Beck's Depression Inventory (BDI), Visual Analogue Scale (EVA), Mcquade's Test and the Roland-Morrys' Questionnaire, developing a pre-treatment and post-treatment assessment.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Almeria, Spain, 04001
    • Almeria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chronic non-specific low back pain persisting ≥ 3 months.
• Age between 25 and 60 years.
• Not currently receiving physical therapy.

Exclusion Criteria:

• Presence of lumbar stenosis.
• Presence of clinical signs of radiculopathy.
• Diagnosis of spondylolisthesis.
• Diagnosis of fibromyalgia.
• Treatment with corticosteroid or pharmachological medication within the paset 2 weeks.
• A history of spinal surgery.
• Central or peripheral nervous system disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercise program; It will be consist in a program of lumbo-pelvic stabilization exercises and strengthening of the core: awareness of breathing, front and side plate abdominal, glute bridge/hip elevations, lift extended leg, pelvic tilt, hamstring stretch, strengthening lower abdominals, cat-camel posture, trunk rotations with flexed knees, rolling in sitting and lumbar extension with hip extensión in prone	Other: Percutaneous electrostimulation treatment (EPS); Apply dry needles in a tight band of some of the muscles that most affect the appearance of low back pain, such as: paravertebral, lumbar quadrate, gluteus medius and pyramidal, and administer analgesic microcurrents.
ACTIVE_COMPARATOR: Percutaneous electrostimulation treatment (EPS); Apply dry needles in a tight band of some of the muscles that most affect the appearance of low back pain, such as: paravertebral, lumbar quadrate, gluteus medius and pyramidal, and administer analgesic microcurrents.	Other: Exercise program; It will be consist in a program of lumbo-pelvic stabilization exercises and strengthening of CORE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Algometry	An instrument for measuring the degree of sensitivity to pain.	At baseline and immediate post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goniometry	Measurement of the range of motion	At baseline and immediate post-treatment
Beck's Depression Inventory	The state of depression will be determined with the Beck Depression Inventory (BDI), a self-applied 21-item questionnaire that assesses a wide spectrum of depressive symptoms. It focuses on the cognitive components of depression, which represent around 50% of the total questionnaire score.	At baseline and immediate post-treatment
Visual Analog Scale	Pain will be assessed with the Visual Analog Scale (VAS), which assesses the pain intensity and degree of relief experienced by the patient (scored of 0 = no pain; 10 = unbearable pain).	At baseline and immediate post-treatment
Oswestry Low Back Pain Disability Index.	It has 10 items associated to activities of daily living, each item has a puntuation fron 0 to 5 points	At baseline and immediate post-treatment
Roland-Morrys' Questionnaire	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	At baseline and immediate post-treatment
Mcquade Test	It measures the isometric endurance of trunk flexion muscles	At baseline and immediate post-treatment

Collaborators and Investigators

• Sponsor: Universidad de Almeria

Publications and helpful links

General Publications

• Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.
• Castro-Sanchez AM, Lara-Palomo IC, Mataran-Penarrocha GA, Fernandez-Sanchez M, Sanchez-Labraca N, Arroyo-Morales M. Kinesio Taping reduces disability and pain slightly in chronic non-specific low back pain: a randomised trial. J Physiother. 2012;58(2):89-95. doi: 10.1016/S1836-9553(12)70088-7. Erratum In: J Physiother. 2012;58(3):143.
• Haas M, Groupp E, Kraemer DF. Dose-response for chiropractic care of chronic low back pain. Spine J. 2004 Sep-Oct;4(5):574-83. doi: 10.1016/j.spinee.2004.02.008.
• Pérez Guisado J. Contribución al estudio de la lumbalgia inespecífica. Rev Cubana Ortop Traumatol. 2006;20(2).
• Hernandez GA, Zamora Salas JD. [Exercise as a treatment for low back pain management]. Rev Salud Publica (Bogota). 2017 Jan-Feb;19(1):123-128. doi: 10.15446/rsap.v19n1.61910. Spanish.
• Sekendiz B, Cug M, Korkusuz F. Effects of Swiss-ball core strength training on strength, endurance, flexibility, and balance in sedentary women. J Strength Cond Res. 2010 Nov;24(11):3032-40. doi: 10.1519/JSC.0b013e3181d82e70. Erratum In: J Strength Cond Res. 2011 Jan;25(1):286.
• Lizier DT, Pérez V, Sakata K. Ejercicios para el tratamiento de la lumbálgia inespecífica. Rev. Bras. Anestesiol. 2012;62(6):842-846.
• Mehrparvar AH, Heydari M, Mirmohammadi SJ, Mostaghaci M, Davari MH, Taheri M. Ergonomic intervention, workplace exercises and musculoskeletal complaints: a comparative study. Med J Islam Repub Iran. 2014 Jul 16;28:69. eCollection 2014.
• Goldby LJ, Moore AP, Doust J, Trew ME. A randomized controlled trial investigating the efficiency of musculoskeletal physiotherapy on chronic low back disorder. Spine (Phila Pa 1976). 2006 May 1;31(10):1083-93. doi: 10.1097/01.brs.0000216464.37504.64.
• Slade SC, Keating JL. Trunk-strengthening exercises for chronic low back pain: a systematic review. J Manipulative Physiol Ther. 2006 Feb;29(2):163-73. doi: 10.1016/j.jmpt.2005.12.011.
• Slade SC, Keating JL. Unloaded movement facilitation exercise compared to no exercise or alternative therapy on outcomes for people with nonspecific chronic low back pain: a systematic review. J Manipulative Physiol Ther. 2007 May;30(4):301-11. doi: 10.1016/j.jmpt.2007.03.010.
• Angel Garcia D, Martinez Nicolas I, Saturno Hernandez PJ, Lopez Soriano F. [Clinical approach to chronic lumbar pain: a systematic review of recommendations included in existing practice guidelines]. An Sist Sanit Navar. 2015 Jan-Apr;38(1):117-30. doi: 10.23938/ASSN.0059. Spanish.
• Barlas P, Ting SL, Chesterton LS, Jones PW, Sim J. Effects of intensity of electroacupuncture upon experimental pain in healthy human volunteers: a randomized, double-blind, placebo-controlled study. Pain. 2006 May;122(1-2):81-9. doi: 10.1016/j.pain.2006.01.012. Epub 2006 Mar 9.
• Mayor D. Electroacupunture: a practical manual and resource. Churchill Livingstone, 2007.
• Hamza MA, Ghoname EA, White PF, Craig WF, Ahmed HE, Gajraj NM, Vakharia AS, Noe CE. Effect of the duration of electrical stimulation on the analgesic response in patients with low back pain. Anesthesiology. 1999 Dec;91(6):1622-7. doi: 10.1097/00000542-199912000-00012.
• Tsukayama H, Yamashita H, Amagai H, Tanno Y. Randomised controlled trial comparing the effectiveness of electroacupuncture and TENS for low back pain: a preliminary study for a pragmatic trial. Acupunct Med. 2002 Dec;20(4):175-80. doi: 10.1136/aim.20.4.175.
• Baldry PE. Acupunture, trigger points and musculoeskeletal pain, 2ª ed. London: Churchill Livingstone;1993.
• Arroyo Fernández R, Martón Villalvilla R, Baldán Bernardino N, Mayoral del Moral O, Salvat Salvat I. Fisioterapia invasiva del síndrome de dolor miofascial: manual de punción seca de puntos gatillos. Panamericana; 2017.
• Sanabria AM. Prevalencia de dolor lumbar y su relación con factores de riesgo biomecánicos en personal de enfermería. 2015;37(4):319-330.
• Vera-García F. Core stability: evaluación y criterios para su entrenamiento. Rev. Andaluza de Medicina del Deporte. 2015;(8(3):130-137.
• Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
• Piovesan EJ, Tatsui CE, Kowacs PA, Lange MC, Pacheco C, Werneck LC. [Using algometry of pressure measuring the threshold of trigeminal pain perception in normal volunteers: a new protocol of studies]. Arq Neuropsiquiatr. 2001 Mar;59(1):92-6. doi: 10.1590/s0004-282x2001000100019. French.
• Martín S, Arroyo R, Baldán N, Martín T, Mayoral O. Electroestimulación percutánea del punto gatillo miofascial: efectos de la frecuencia sobre el umbral de dolor a la presión. Cuest Fisioter. 2014;43(2):110-120.
• Manning DC, Rowlingson JC. Back pain and the role of neural blockade. Neural blockade in clinical anesthesia and management of pain. 3º ed. Philadelphia 1998;879.
• Medrano García R, Varela Hernández A, de la Torre Rosés M, Mendoza Cisneros R. Propuesta de modificación del algoritmo europeo de manejo de la lumbalgia inespecífica. 2010;14(4).

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2018
• Primary Completion (ACTUAL): April 16, 2018
• Study Completion (ACTUAL): May 16, 2018

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (ACTUAL): January 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 6, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: chronic low back pain; physical therapy; randomized clinical trial; exercise program
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: UAL-477

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No