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

Low Back Pain Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794869
• Other study ID #: UAL-477
• Status: Completed
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: May 16, 2018

Study information

• Verified date: January 2019
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 16, 2018
• Est. primary completion date: April 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Electroacupuncture
• Exercise Program
• Low Back Pain

Intervention

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.
• Exercise program
It will be consist in a program of lumbo-pelvic stabilization exercises and strengthening of CORE.

Locations

Country	Name	City	State
Spain	Almeria University	Almeria

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

References & Publications (25)

Ángel García D, Martínez Nicolás I, Saturno Hernández PJ, López 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. Review. Spanish. — View Citation

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.

Baldry PE. Acupunture, trigger points and musculoeskeletal pain, 2ª ed. London: Churchill Livingstone;1993.

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. Epub 2006 Mar 9. — View Citation

Castro-Sánchez AM, Lara-Palomo IC, Matarán-Peñarrocha GA, Fernández-Sánchez M, Sánchez-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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hernández 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. — View Citation

Lizier DT, Pérez V, Sakata K. Ejercicios para el tratamiento de la lumbálgia inespecífica. Rev. Bras. Anestesiol. 2012;62(6):842-846.

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.

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.

Mayor D. Electroacupunture: a practical manual and resource. Churchill Livingstone, 2007.

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).

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. — View Citation

Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49. pii: S0034-89102015000100408. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20. Review. — View Citation

Pérez Guisado J. Contribución al estudio de la lumbalgia inespecífica. Rev Cubana Ortop Traumatol. 2006;20(2).

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. French. — View Citation

Sanabria AM. Prevalencia de dolor lumbar y su relación con factores de riesgo biomecánicos en personal de enfermería. 2015;37(4):319-330.

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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):157-68. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Algometry	An instrument for measuring the degree of sensitivity to pain.	At baseline and immediate post-treatment
Secondary	Goniometry	Measurement of the range of motion	At baseline and immediate post-treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mcquade Test	It measures the isometric endurance of trunk flexion muscles	At baseline and immediate post-treatment