Rehabilitation of Dynamic Muscle, Back Pain and Postural Balance

Low Back Pain Clinical Trial

— RDM  

Official title:

Rehabilitation of Dynamic Muscle, Back Pain and Postural Balance of Industrial Operators

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01011270
• Other study ID #: RDM - 0012009
• Secondary ID: RDM0012009UCB
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 10, 2009
• Last updated: November 10, 2009
• Start date: July 2009
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: Universidade Castelo Branco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

The aim of this study was to investigate the effect of rehabilitation of the dynamic muscle (RDM®) in back pain and postural balance of industrial operators. 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 were randomly selected and divided at random in: experimental group (GE, n = 41, age = 41 ± 4 years, body mass index (IMC) = 26.46 ± 3 , 25) and control group (CG, n = 42, age = 42 ± 5 years, IMC = 26.47 ± 3.34).

The GE was part of treatment with RDM. The CG was composed of individuals who did not participate in any physical therapy treatment during the search. The procedures used for evaluation were: back pain (Borg scale) and postural balance (pedana stabilometric and posturométrica). The process of intervention by the RDM had a duration of 20 minutes, frequency of twice a week and was extended for 12 weeks, and the systematic treatment performed on 4 occasions.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 82
• Est. completion date: November 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Locations

Country	Name	City	State
Brazil	Francisco Miguel Pinto	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Castelo Branco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes