Recurrent Low Back PainNCT02112760
Specific Stabilization Exercise With Ultrasound Feedback For Patient With Recurrent Low Back Pain
A study testing specific stabilization exercise in people with Recurrent Low Back Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
1. Specific aim 1:Identify factors that influence muscle performance by use of ultrasound imaging. Hypothesis: Gender, age, and BMI affect the muscle performance of deep trunk muscles. 2. Specific aim 2. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Low Back Pain
- What is being tested?
- specific stabilization exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2011to Dec 2012
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- recurrent low back pain for at least the past year
- lumbar region discomfort more than one day in the past three months
- recurrent discomfort more than one time in the past three months
Who cannot join
- pregnancy
- carcinoma
- systematic disease (rheumatic arthritis, ankylosing spondylitis etc)
- had surgery on lumbar region or lower extremities
- neurological symptom on lower extremities(numbness, pain etc)
- spondylolisthesis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School of Physical Therapy, National Taiwan University
Taipei, ZhongZeng District, 10060
About this study
- Specific aim 1:Identify factors that influence muscle performance by use of ultrasound imaging. Hypothesis: Gender, age, and BMI affect the muscle performance of deep trunk muscles.
- Specific aim 2. To compare the performance of trunk deep muscles (transversus abdominis and multifidus) and the sensation and pain thresholds of patients with recurrent low back pain with asymptomatic subjects. Hypothesis: patients with recurrent low back pain have: (A) less activation of the transversus abdominis and multifidus, (B) peripheral and central sensitization, with decreased sensation and pain thresholds in the lumbar and foot areas.
- Specific aim 3. To determine the performance of the transversus abdominis and multifidus, and the sensation and pain thresholds by use of ultrasound feedback training in asymptomatic adults, and to compare these results with the traditional training protocols for trunk stabilization. Hypothesis: Specific stabilization exercise using ultrasound feedback training is more effective in activating deep trunk muscles and increasing sensation and pain thresholds than the traditional stabilization training protocol in asymptomatic adults.
- Specific aim 4. To determine the performance of the transversus abdominis and multifidus, and the sensation and pain thresholds by using the ultrasound feedback training in adults with low back pain, and to compare these results with the traditional training protocols for trunk stabilization.
Hypothesis: Specific stabilization exercise using ultrasound feedback training is more effective in activating deep trunk muscles and increasing sensation and pain thresholds than the traditional stabilization training protocol in adults with low back pain.
- Conditions
- Recurrent Low Back Pain
- Being tested
- specific stabilization exercise
- Keywords
- specific stabilization exercise, ultrasound, low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific stabilization exerciseOther
The specific stabilization exercise refers to an exercise that targets the deep trunk muscle, including the multifidus and transversus abdominis with ultrasound feedback.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | To evaluate the effect of specific stabilization intervention in recurrent low back pain participants Receives: Other: specific stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased change of sliding of transversus abdominis muscle and change of thickness on multifidus muscle in asymptomatic and low back pain group
Measured: pre treatment (0 week), post treatment(6 week)
Secondary outcomes (1)
Decrease cold sensation threshold on left back and hot sensation threshold on left leg in both group
Measured: pre treatment (0 week), post treatment(6 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startJun 2011
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Low Back PainStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
- Investigators
- Shwu-Fen Wang, Ph.D, Study director, chool of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112760
- Sponsor's protocol ID
- 200903075R
- Status last verified
- Apr 2014
- First submitted
- 10 Apr 2014
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Stabilization Exercise With Ultrasound Feedback For Patient With Recurrent Low Back Pain
- ClinicalTrials.gov ID
- NCT02112760
- Acronym / sponsor ID
- 200903075R
- Conditions
- Recurrent Low Back Pain
- Keywords
- specific stabilization exercise, ultrasound, low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (actual)
- First posted
- 14 Apr 2014 (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.
- Specific aim 1:Identify factors that influence muscle performance by use of ultrasound imaging. Hypothesis: Gender, age, and BMI affect the muscle performance of deep trunk muscles.
- Specific aim 2. To compare the performance of trunk deep muscles (transversus abdominis and multifidus) and the sensation and pain thresholds of patients with recurrent low back pain with asymptomatic subjects. Hypothesis: patients with recurrent low back pain have: (A) less activation of the transversus abdominis and multifidus, (B) peripheral and central sensitization, with decreased sensation and pain thresholds in the lumbar and foot areas.
- Specific aim 3. To determine the performance of the transversus abdominis and multifidus, and the sensation and pain thresholds by use of ultrasound feedback training in asymptomatic adults, and to compare these results with the traditional training protocols for trunk stabilization. Hypothesis: Specific stabilization exercise using ultrasound feedback training is more effective in activating deep trunk muscles and increasing sensation and pain thresholds than the traditional stabilization training protocol in asymptomatic adults.
- Specific aim 4. To determine the performance of the transversus abdominis and multifidus, and the sensation and pain thresholds by using the ultrasound feedback training in adults with low back pain, and to compare these results with the traditional training protocols for trunk stabilization.
Hypothesis: Specific stabilization exercise using ultrasound feedback training is more effective in activating deep trunk muscles and increasing sensation and pain thresholds than the traditional stabilization training protocol in adults with low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Other: specific stabilization exerciseTo evaluate the effect of specific stabilization intervention in recurrent low back pain participants |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- recurrent low back pain for at least the past year
- lumbar region discomfort more than one day in the past three months
- recurrent discomfort more than one time in the past three months
Key exclusion criteria (6 listed)
- pregnancy
- carcinoma
- systematic disease (rheumatic arthritis, ankylosing spondylitis etc)
- had surgery on lumbar region or lower extremities
- neurological symptom on lower extremities(numbness, pain etc)
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 |
|---|---|---|
| specific stabilization exerciseThe specific stabilization exercise refers to an exercise that targets the deep trunk muscle, including the multifidus and transversus abdominis with ultrasound feedback. | Other | Patient |
Primary outcome
Increased change of sliding of transversus abdominis muscle and change of thickness on multifidus muscle in asymptomatic and low back pain group
Time frame: pre treatment (0 week), post treatment(6 week)
1 secondary outcome
Decrease cold sensation threshold on left back and hot sensation threshold on left leg in both group
Time frame: pre treatment (0 week), post treatment(6 week)
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 14 Apr 2014.
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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.
Shwu-Fen Wang, Ph.D study director
chool of Physical Therapy, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing specific stabilization exercise in people with Recurrent Low Back Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 6 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 14 Apr 2014. 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 Taiwan. 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?
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.
What does the primary outcome measure?
Increased change of sliding of transversus abdominis muscle and change of thickness on multifidus muscle in asymptomatic and low back pain group (time frame: pre treatment (0 week), post treatment(6 week)). 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 14 Apr 2014.