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

Primary Purpose

Low Back Pain, Exercise Program, Electroacupuncture

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Percutaneous electrostimulation treatment (EPS)
Exercise program
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring chronic low back pain, physical therapy, randomized clinical trial, exercise program

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Almeria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise program

Percutaneous electrostimulation treatment (EPS)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Algometry
An instrument for measuring the degree of sensitivity to pain.

Secondary Outcome Measures

Goniometry
Measurement of the range of motion
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.
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).
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
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
Mcquade Test
It measures the isometric endurance of trunk flexion muscles

Full Information

First Posted
January 3, 2019
Last Updated
January 6, 2019
Sponsor
Universidad de Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT03794869
Brief Title
Short-term Effects of Exercise Program Versus Electropuncture in Patients With Chronic Non-specific Low Back Pain: A Randomized 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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
April 16, 2018 (Actual)
Study Completion Date
May 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Exercise Program, Electroacupuncture
Keywords
chronic low back pain, physical therapy, randomized clinical trial, exercise program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single-Blind
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise program
Arm Type
Experimental
Arm Description
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
Arm Title
Percutaneous electrostimulation treatment (EPS)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Percutaneous electrostimulation treatment (EPS)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise program
Intervention Description
It will be consist in a program of lumbo-pelvic stabilization exercises and strengthening of CORE.
Primary Outcome Measure Information:
Title
Algometry
Description
An instrument for measuring the degree of sensitivity to pain.
Time Frame
At baseline and immediate post-treatment
Secondary Outcome Measure Information:
Title
Goniometry
Description
Measurement of the range of motion
Time Frame
At baseline and immediate post-treatment
Title
Beck's Depression Inventory
Description
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.
Time Frame
At baseline and immediate post-treatment
Title
Visual Analog Scale
Description
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).
Time Frame
At baseline and immediate post-treatment
Title
Oswestry Low Back Pain Disability Index.
Description
It has 10 items associated to activities of daily living, each item has a puntuation fron 0 to 5 points
Time Frame
At baseline and immediate post-treatment
Title
Roland-Morrys' Questionnaire
Description
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
Time Frame
At baseline and immediate post-treatment
Title
Mcquade Test
Description
It measures the isometric endurance of trunk flexion muscles
Time Frame
At baseline and immediate post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Almeria University
City
Almeria
ZIP/Postal Code
04001
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
15363431
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. doi: 10.1016/j.spinee.2004.02.008.
Results Reference
background
Citation
Pérez Guisado J. Contribución al estudio de la lumbalgia inespecífica. Rev Cubana Ortop Traumatol. 2006;20(2).
Results Reference
background
PubMed Identifier
30137166
Citation
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.
Results Reference
background
PubMed Identifier
20940644
Citation
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.
Results Reference
background
PubMed Identifier
22613238
Citation
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.
Results Reference
background
PubMed Identifier
26487293
Citation
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.
Results Reference
background
Citation
Lizier DT, Pérez V, Sakata K. Ejercicios para el tratamiento de la lumbálgia inespecífica. Rev. Bras. Anestesiol. 2012;62(6):842-846.
Results Reference
background
PubMed Identifier
25405134
Citation
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.
Results Reference
background
PubMed Identifier
16648741
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. doi: 10.1097/01.brs.0000216464.37504.64.
Results Reference
background
PubMed Identifier
16461178
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. doi: 10.1016/j.jmpt.2005.12.011.
Results Reference
background
PubMed Identifier
17509439
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. doi: 10.1016/j.jmpt.2007.03.010.
Results Reference
background
PubMed Identifier
25963464
Citation
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.
Results Reference
background
PubMed Identifier
16527396
Citation
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.
Results Reference
background
Citation
Mayor D. Electroacupunture: a practical manual and resource. Churchill Livingstone, 2007.
Results Reference
background
PubMed Identifier
10598602
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. doi: 10.1097/00000542-199912000-00012.
Results Reference
background
PubMed Identifier
12512791
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. doi: 10.1136/aim.20.4.175.
Results Reference
background
Citation
Baldry PE. Acupunture, trigger points and musculoeskeletal pain, 2ª ed. London: Churchill Livingstone;1993.
Results Reference
background
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.
Results Reference
background
Citation
Sanabria AM. Prevalencia de dolor lumbar y su relación con factores de riesgo biomecánicos en personal de enfermería. 2015;37(4):319-330.
Results Reference
background
Citation
Vera-García F. Core stability: evaluación y criterios para su entrenamiento. Rev. Andaluza de Medicina del Deporte. 2015;(8(3):130-137.
Results Reference
background
PubMed Identifier
8455963
Citation
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.
Results Reference
background
PubMed Identifier
11299439
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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).
Results Reference
background

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

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