Vibratory Therapy for Patients With Chronic Low Back Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Laboratório de Engenharia de Reabilitação Sensorio Motora
Sponsor:
Information provided by (Responsible Party):
Djenifer Queiroz de Souza, Laboratório de Engenharia de Reabilitação Sensorio Motora
ClinicalTrials.gov Identifier:
NCT02014948
First received: November 7, 2013
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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 Intervention
Low Back Pain
Other: Exercises

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Implementation of a Physiotherapy Intervention for Patients With Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Laboratório de Engenharia de Reabilitação Sensorio Motora:

Primary Outcome Measures:
  • Electromyographic analysis of the trunk erector of patients with chronic low back pain . [ Time Frame: Thirty seconds. ] [ Designated as safety issue: No ]

    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:
  • Analysis of pain using a visual analogue scale . [ Time Frame: Two days. ] [ Designated as safety issue: No ]
    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:
  • Force Platform [ Time Frame: Thirty seconds ] [ Designated as safety issue: No ]
    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 .


Estimated Enrollment: 30
Study Start Date: June 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
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
Study First Received: November 7, 2013
Last Updated: December 12, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on July 23, 2014