NCT02014948

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 .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

December 19, 2013

Status Verified

December 1, 2013

Enrollment Period

8 months

First QC Date

November 7, 2013

Last Update Submit

December 12, 2013

Conditions

Keywords

Low Back PainPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Electromyographic analysis of the trunk erector of patients with chronic low back pain .

    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 .

    Thirty seconds.

Secondary Outcomes (1)

  • Analysis of pain using a visual analogue scale .

    Two days.

Other Outcomes (1)

  • Force Platform

    Thirty seconds

Study Arms (1)

Exercises

EXPERIMENTAL

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

Interventions

The individuals who make up this group performed exercises for 10 consecutive sessions.

Exercises

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Presence of vertebral pathologies or symptoms that involve the same;
  • The use of anti -inflammatory steroids or nonsteroidal;
  • Women in menstrual period;
  • Pregnant or postpartum;
  • Cognitive deficits;
  • Hyperesthesia, hypoesthesia or anesthesia evaluated muscle group;
  • Surgery in the previous column;
  • The presence of infiltration of corticosteroids in less than six months;
  • The use of anti -inflammatory steroids or nonsteroidal;
  • The use of analgesics;
  • Cognitive deficits;
  • Collections in menstrual period;
  • Pregnant and postpartum;
  • Hemorrhage;
  • Malignancy;
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vale of Paraiba

São José dos Campos, São Paulo, Brazil

RECRUITING

Related Publications (2)

  • Basbaum AI, Bautista DM, Scherrer G, Julius D. Cellular and molecular mechanisms of pain. Cell. 2009 Oct 16;139(2):267-84. doi: 10.1016/j.cell.2009.09.028.

    PMID: 19837031BACKGROUND
  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Djenifer Q Souza, Therapy

    University of Vale of Paraiba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Djenifer Q Souza, Therapy

CONTACT

Mariana R Reis, Therapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Djenifer Queiroz de Souza

Study Record Dates

First Submitted

November 7, 2013

First Posted

December 19, 2013

Study Start

June 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

December 19, 2013

Record last verified: 2013-12

Locations