Low Back PainRDMNCT01011270
Rehabilitation of Dynamic Muscle, Back Pain and Postural Balance
An observational study of Low Back Pain, run by Universidade Camilo Castelo Branco at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2009to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- FCC officials with medical indication of low back pain to perform physical therapy or medical
Who cannot join
- The investigators excluded patients who were doing treatment with medication and who reported worsening of the crisis period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation of Dynamic Muscle, Back Pain and Postural Balance of Industrial Operators
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.
Read the detailed 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.
- Conditions
- Low Back Pain
- Keywords
- Back pain, postural balance, RDM, industrial operators
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2009
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Camilo Castelo Branco
- Sponsor type
- University, hospital or other
- Investigators
- Francisco Miguel, 3 Grau, Principal investigator, Castelo Branco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011270
- Sponsor's protocol ID
- RDM - 0012009
- Other IDs
- RDM0012009UCB
- Acronym
- RDM
- Status last verified
- Nov 2009
- First submitted
- 10 Nov 2009
- Last updated
- 11 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Dynamic Muscle, Back Pain and Postural Balance of Industrial Operators
- ClinicalTrials.gov ID
- NCT01011270
- Acronym / sponsor ID
- RDM / RDM - 0012009
- Conditions
- Low Back Pain
- Keywords
- Back pain, postural balance, RDM, industrial operators
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Universidade Camilo Castelo BrancoUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Nov 2009 (estimated)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- FCC officials with medical indication of low back pain to perform physical therapy or medical
Key exclusion criteria (1 listed)
- The investigators excluded patients who were doing treatment with medication and who reported worsening of the crisis period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: three months
1 secondary outcome
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).
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Miguel, 3 Grau principal investigator
Castelo Branco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Universidade Camilo Castelo Branco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2009.