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Vibratory Therapy for Patients With Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT02014948
Recruitment Status : Unknown
Verified December 2013 by Djenifer Queiroz de Souza, Laboratório de Engenharia de Reabilitação Sensorio Motora.
Recruitment status was:  Recruiting
First Posted : December 19, 2013
Last Update Posted : December 19, 2013
Sponsor:
Information provided by (Responsible Party):
Djenifer Queiroz de Souza, Laboratório de Engenharia de Reabilitação Sensorio Motora

Brief Summary:

The lumbar spine is currently one of the most affected areas by nociceptive processes , referred back pain, which can be provided from a herniated intervertebral disc . Such conditions are considered a public health problem , since considerably affect the population , mainly young adults , which may lead to functional disability and absenteeism . Soon , his treatment involves high costs and rehabilitation time indefinite , generating great scientific interest focused on the search for new techniques that can provide an acceleration of functional recovery of these individuals .

Thus , the establishment of evaluation protocols that provide quantitative data concerning the functional capacity is of utmost importance . From the electromyographic analysis , one can measure the electrical activity of muscle and identify abnormal patterns of response. For the identification of kinematic changes becomes useful equipment capable of recording the speed and angle of movement, as the accelerometer . Another evaluation method applicable to cases of herniated disc and back pain is the force platform to quantify the ground reaction force during the stance phase of the movement . Also , the quality of life should be taken into account as routinely observed psychological impairment involving issues related to vitality, emotional and social aspects , which can be identified through the questionnaire of quality of life ( SF -36 ) .

With regard to physical therapy intervention , we seek to use resources to compose promising treatment program along with conventionalexercises. A novel therapy in the treatment of back pain is the whole body vibration , as it promotes increased range of muscle spindles via increasing the tonic vibration reflex and consequently improving the mechanism of involuntary muscle control . Thus , the association between an accurate assessment , exercises and therapy vibratory seeks early rehabilitate individuals affected by back pain or herniated disc , delaying or even avoiding surgery .


Condition or disease Intervention/treatment Phase
Low Back Pain Other: Exercises Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementation of a Physiotherapy Intervention for Patients With Chronic Low Back Pain
Study Start Date : June 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Exercises
This group will consist of 20 individuals, 10 with lumbar disc herniation and 10 with chronic low back pain who underwent treatment with exerxises.
Other: Exercises
The individuals who make up this group performed exercises for 10 consecutive sessions.



Primary Outcome Measures :
  1. Electromyographic analysis of the trunk erector of patients with chronic low back pain . [ Time Frame: Thirty seconds. ]

    All groups performed the evaluation of muscle electrical activity , using a surface electromyography , 2 channels ( EMG System ® ) , model EMG 230C - USB , composed of an analog-digital converter 12-bit resolution and power supply to battery to avoid interference from the power grid . The parameters used were : sampling frequency of 2,000 Hz , unit uV , -2000 Xmin , Ymax 2000 Coef . The 0 and Coef . B 500.

    The electrodes were then fixed in pairs , respecting the distance of 2 cm between them ; longitudinally over the belly of the erector muscles of the trunk . Data were collected in the prone and standing for 30 seconds , during which the subject performed the isotonic contraction muscle evaluated .



Secondary Outcome Measures :
  1. Analysis of pain using a visual analogue scale . [ Time Frame: Two days. ]
    The subjects were instructed to respond to a visual analogue scale with the level 0 as no pain and 10 as state level of maximum pain .


Other Outcome Measures:
  1. Force Platform [ Time Frame: Thirty seconds ]
    The acquisition of data on the force platform lasted 30 seconds , during which patients took the standing position in the region previously marked on the equipment , so that the support base was identical for all volunteers . Also , samples were collected at rest , followed by consecutive flexion-extension of the trunk .



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • Inclusion criteria:

    1. Lack of diseases or complaints of back pain;
    2. Medical diagnosis of lumbar disc herniation , evidenced by imaging studies;
    3. Low back pain or sciatica in the presence of antalgic postures;
    4. 80% stake in therapy sessions;
    5. Individuals who agree to participate in this study and signed an informed consent form.
  • Exclusion criteria:

    1. Presence of vertebral pathologies or symptoms that involve the same;
    2. The use of anti -inflammatory steroids or nonsteroidal;
    3. Women in menstrual period;
    4. Pregnant or postpartum;
    5. Cognitive deficits;
    6. Hyperesthesia, hypoesthesia or anesthesia evaluated muscle group;
    7. Surgery in the previous column;
    8. The presence of infiltration of corticosteroids in less than six months;
    9. The use of anti -inflammatory steroids or nonsteroidal;
    10. The use of analgesics;
    11. Cognitive deficits;
    12. Collections in menstrual period;
    13. Pregnant and postpartum;
    14. Hemorrhage;
    15. Malignancy;
    16. Diabetes mellitus;
    17. Deep venous thrombosis;
    18. Regions healing;
    19. Acute inflammation;
    20. Fracture healing;
    21. Pressure ulcers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014948


Contacts
Contact: Djenifer Q Souza, Therapy 982471972 djeniferqs@gmail.com
Contact: Mariana R Reis, Therapy 988291319 mah.crr@gmail.com

Locations
Brazil
University of Vale of Paraiba Recruiting
São José dos Campos, São Paulo, Brazil
Contact: Djenifer Q Souza, Therapy    982471972    djeniferqs@gmail.com   
Sub-Investigator: Djenifer Q Souza, Therapy         
Sponsors and Collaborators
Laboratório de Engenharia de Reabilitação Sensorio Motora
Investigators
Principal Investigator: Djenifer Q Souza, Therapy University of Vale of Paraiba

Additional Information:
Publications:
AHRENS, C.; SCHILTENWOLF, M.; WANG, H. Health-related quality of life (SF-36) inchronic low back pain and comorbid depression. Schmerz, v. 24, n. 3, p. 251-256, 2010. BASSANI, E. et al. Avaliação da ativação neuromuscular em indivíduos com escoliose através da eletromiografia de superfície. Rev. bras. fisioter., v. 12, n. 1, p. 13-19, 2008. BOSCO, C.; CARDINALE, M.; TSARPELA, O. Infuence of vibration on mechanical power and electromyogram activity in human arm flexor muscles. Eur. J. Appl. Physiol., v. 79, p. 306-311, 1999. BRAZIL et al. Diagnóstico e tratamento das lombalgias e lombociatalgias. Rev. Bras. Reumatol., v. 44, n. 6, p. 419-425, 2004. KISNER, C.; COLBY, L. A. Exercícios Terapêuticos: fundamentos e técnicas. 4 ed., Barueri: Manole, 2004. LIZIER, D. T. et al. Exercícios para tratamento de lombalgia inespecífica. Rev. Bras. Anestesiol., v. 62, n. 6, p. 838-846, 2012.

Responsible Party: Djenifer Queiroz de Souza, Laboratório de Engenharia de Reabilitação Sensorio Motora
ClinicalTrials.gov Identifier: NCT02014948     History of Changes
Other Study ID Numbers: CAAE: 13527313.3.0000.5503
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013

Keywords provided by Djenifer Queiroz de Souza, Laboratório de Engenharia de Reabilitação Sensorio Motora:
Low Back Pain
Physiotherapy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms