Low Back PainPhase 4NCT00752674
Neuromuscular Balance in Low Back Pain
A Phase 4 study testing Neuromuscular balance in people with Low Back Pain, run by Fortaleza University.
Trial summary
The research was an interventional study with a quantitative board, fulfilled in a private clinique specialized in trauma service; it was formed between august to October of 2006. The objective was to investigate the effectiveness of neuromuscular balance in lumbar pain. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Neuromuscular balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Nov 2006
- Phase
- Phase 4
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with low back pain between 20 and 55 years old, submitted to a physical therapy treatment.
Who cannot join
- Patients with no miofascial low back pain
About this study
Official title: The Effectiveness of Neuromuscular Balance in Low Back Pain
The research was an interventional study with a quantitative board, fulfilled in a private clinique specialized in trauma service; it was formed between august to October of 2006. The objective was to investigate the effectiveness of neuromuscular balance in lumbar pain. The 12 patients, with age between 20 and 55 years, whose did five consultations, with 100% presence, got relief of the pain and increase of movement of hips' articulation which was the most painful movement with 91,66% graduation. All the patients presented the shorting test positive and it kept positive in 7 patients. There was a significant improvement in pain relief (p=0,001,) comparing the first and the fifth consultation, and hip articulation movement. Even after the relief of the pain, 7(58,3%) of the patients kept the treatment for a more effective rehabilitation and prevention of repetition of the symptoms. It was concluded that the neuromuscular balance relieved quickly the pain, being essential for effective rehabilitation of low back pain, with the inclusion of others manual techniques.
Read the detailed description
The low back pain is a symptom presented in muscle-skeletal change on lumbar region, preferring young adults, in economic active fase. The neuromuscular balance was developed by Soulier when he met the "activator methods" which was a pen that create vibrations and consist in a vibration or a micro thrust to reduce the articulation and spinal problems through a non manipulative correction. The research was un interventional study with a quantitative board, fulfilled in a private clinique specialized in trauma service; it was formed between august to October of 2006. The objective was to investigate the effectiveness of neuromuscular balance in lumbar pain. The 12 patients, with age between 20 and 55 years, whose did five consultations, with 100% presence, got relief of the pain and increase of movement of hips' articulation which was the most painful movement with 91,66% graduation. All the patients presented the shorting test positive and it kept positive in 7 patients. There was a significant improvement in pain relief (p=0,001,) comparing the first and the fifth consultation, and hip articulation movement. Even after the relief of the pain, 7(58,3%) of the patients kept the treatment for a more effective rehabilitation and prevention of repetition of the symptoms. It was concluded that the neuromuscular balance relieved quickly the pain, being essential for effective rehabilitation of low back pain, with the inclusion of others manual techniques.
- Conditions
- Low Back Pain
- Being tested
- Neuromuscular balance
- Keywords
- Low back pain, physical therapy, pain
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular balanceOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Neuromuscular balance Receives: Other: Neuromuscular balance |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startAug 2006
- Primary completionOct 2006
- Study completionNov 2006
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fortaleza University
- Sponsor type
- University, hospital or other
- Investigators
- Karla Adryana Diniz Meireles, Master, Principal investigator, Fortaleza University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752674
- Sponsor's protocol ID
- 265-2006
- Status last verified
- Sep 2008
- First submitted
- 11 Sep 2008
- Last updated
- 15 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Neuromuscular Balance in Low Back Pain
- ClinicalTrials.gov ID
- NCT00752674
- Acronym / sponsor ID
- 265-2006
- Conditions
- Low Back Pain
- Keywords
- Low back pain, physical therapy, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fortaleza UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 15 Sep 2008 (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.
The research was an interventional study with a quantitative board, fulfilled in a private clinique specialized in trauma service; it was formed between august to October of 2006. The objective was to investigate the effectiveness of neuromuscular balance in lumbar pain. The 12 patients, with age between 20 and 55 years, whose did five consultations, with 100% presence, got relief of the pain and increase of movement of hips' articulation which was the most painful movement with 91,66% graduation. All the patients presented the shorting test positive and it kept positive in 7 patients. There was a significant improvement in pain relief (p=0,001,) comparing the first and the fifth consultation, and hip articulation movement. Even after the relief of the pain, 7(58,3%) of the patients kept the treatment for a more effective rehabilitation and prevention of repetition of the symptoms. It was concluded that the neuromuscular balance relieved quickly the pain, being essential for effective rehabilitation of low back pain, with the inclusion of others manual techniques.
Detailed description
The low back pain is a symptom presented in muscle-skeletal change on lumbar region, preferring young adults, in economic active fase. The neuromuscular balance was developed by Soulier when he met the "activator methods" which was a pen that create vibrations and consist in a vibration or a micro thrust to reduce the articulation and spinal problems through a non manipulative correction. The research was un interventional study with a quantitative board, fulfilled in a private clinique specialized in trauma service; it was formed between august to October of 2006. The objective was to investigate the effectiveness of neuromuscular balance in lumbar pain. The 12 patients, with age between 20 and 55 years, whose did five consultations, with 100% presence, got relief of the pain and increase of movement of hips' articulation which was the most painful movement with 91,66% graduation. All the patients presented the shorting test positive and it kept positive in 7 patients. There was a significant improvement in pain relief (p=0,001,) comparing the first and the fifth consultation, and hip articulation movement. Even after the relief of the pain, 7(58,3%) of the patients kept the treatment for a more effective rehabilitation and prevention of repetition of the symptoms. It was concluded that the neuromuscular balance relieved quickly the pain, being essential for effective rehabilitation of low back pain, with the inclusion of others manual techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Neuromuscular balanceNeuromuscular balance |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with low back pain between 20 and 55 years old, submitted to a physical therapy treatment.
Key exclusion criteria (1 listed)
- Patients with no miofascial low back pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular balance | Other | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2008.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Karla Adryana Diniz Meireles, Master principal investigator
Fortaleza University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neuromuscular balance in people with Low Back Pain, run by Fortaleza University.
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: finished, as of the sponsor's last update on 15 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 15 Sep 2008.