NCT01011270

Brief Summary

Workers in the various branches of the investigators industrial society can be considered as a group susceptible to risks due to the nature of its activities related to the intense demands of their work units with varying degrees of physical overload. Among the risk factors involved in postural genesis of occupational low back pain is work in uncomfortable positions, such as maintenance of static postures for long periods of time and frequent implementation of flexion, extension and trunk rotation.The association between body instability (lack of postural balance) and back pain is seen with some frequency, especially in working groups.

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
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
Last Updated

November 11, 2009

Status Verified

November 1, 2009

Enrollment Period

2 months

First QC Date

November 10, 2009

Last Update Submit

November 10, 2009

Conditions

Keywords

Back painpostural balanceRDMindustrial operators

Outcome Measures

Primary Outcomes (1)

  • In intra-group comparison, the paired t test or Wilcoxon showed, respectively, a significant improvement (p <0.05) in the variables back pain (p = 0.0001) and postural balance (p = 0.0001) in GE.

    three months

Secondary Outcomes (1)

  • Kruskal Wallis test followed by the confidence interval (CI) showed significant improvements in favor of GE's post-test compared to post-test of the GC (back pain: CI: -115.58 / -48.66; postural balance: CI: -68.81 / -1.89).

    three months

Study Arms (2)

Back pain

The aim of this study was to investigate the effect of rehabilitation of the dynamic ;(RDM) in balance and balance of industrial operators. The sample consisted of industrial operators, individuals with low back pain, referred to the industry of Physical Therapy

Balance

the treatment with RDM reflected in significant improvement in back pain and postural balance of industrial operators.

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The sample consisted of industrial operators, individuals with low back pain, referred to the industry of Physical Therapy. After the screening criteria of inclusion and exclusion, 82 individuals

You may qualify if:

  • FCC officials with medical indication of low back pain to perform physical therapy or medical

You may not qualify if:

  • The investigators excluded patients who were doing treatment with medication and who reported worsening of the crisis period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francisco Miguel Pinto

Rio de Janeiro, Rio de Janeiro, 23045830, Brazil

Location

MeSH Terms

Conditions

Low Back PainBack Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Francisco Miguel, 3 Grau

    Castelo Branco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 11, 2009

Study Start

July 1, 2009

Primary Completion

September 1, 2009

Study Completion

November 1, 2009

Last Updated

November 11, 2009

Record last verified: 2009-11

Locations