NCT03794869

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2018

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

1 day

First QC Date

January 3, 2019

Last Update Submit

January 6, 2019

Conditions

Keywords

chronic low back painphysical therapyrandomized clinical trialexercise program

Outcome Measures

Primary Outcomes (1)

  • Algometry

    An instrument for measuring the degree of sensitivity to pain.

    At baseline and immediate post-treatment

Secondary Outcomes (6)

  • Goniometry

    At baseline and immediate post-treatment

  • Beck's Depression Inventory

    At baseline and immediate post-treatment

  • Visual Analog Scale

    At baseline and immediate post-treatment

  • Oswestry Low Back Pain Disability Index.

    At baseline and immediate post-treatment

  • Roland-Morrys' Questionnaire

    At baseline and immediate post-treatment

  • +1 more secondary outcomes

Study Arms (2)

Exercise program

EXPERIMENTAL

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)

Percutaneous electrostimulation treatment (EPS)

ACTIVE COMPARATOR

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

Interventions

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.

Percutaneous electrostimulation treatment (EPS)

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Almeria University

Almería, 04001, Spain

Location

Related Publications (25)

  • 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.

    PMID: 15363431BACKGROUND
  • Pérez Guisado J. Contribución al estudio de la lumbalgia inespecífica. Rev Cubana Ortop Traumatol. 2006;20(2).

    BACKGROUND
  • 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.

    PMID: 30137166BACKGROUND
  • 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.

    PMID: 20940644BACKGROUND
  • 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.

    PMID: 22613238BACKGROUND
  • 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.

    PMID: 26487293BACKGROUND
  • Lizier DT, Pérez V, Sakata K. Ejercicios para el tratamiento de la lumbálgia inespecífica. Rev. Bras. Anestesiol. 2012;62(6):842-846.

    BACKGROUND
  • 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.

    PMID: 25405134BACKGROUND
  • 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.

    PMID: 16648741BACKGROUND
  • 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.

    PMID: 16461178BACKGROUND
  • 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.

    PMID: 17509439BACKGROUND
  • 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.

    PMID: 25963464BACKGROUND
  • 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.

    PMID: 16527396BACKGROUND
  • Mayor D. Electroacupunture: a practical manual and resource. Churchill Livingstone, 2007.

    BACKGROUND
  • 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.

    PMID: 10598602BACKGROUND
  • 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.

    PMID: 12512791BACKGROUND
  • Baldry PE. Acupunture, trigger points and musculoeskeletal pain, 2ª ed. London: Churchill Livingstone;1993.

    BACKGROUND
  • 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.

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

    BACKGROUND
  • Vera-García F. Core stability: evaluación y criterios para su entrenamiento. Rev. Andaluza de Medicina del Deporte. 2015;(8(3):130-137.

    BACKGROUND
  • 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.

    PMID: 8455963BACKGROUND
  • 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.

    PMID: 11299439BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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).

    BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single-Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD(Lecturer)

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 7, 2019

Study Start

April 15, 2018

Primary Completion

April 16, 2018

Study Completion

May 16, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations