Low Back Pain, MechanicalNCT01269619
Comparative Study of Static and Dynamic Back Supports for Lower Back Pain
A study testing Dynamic back support and Static back support in people with Low Back Pain, Mechanical, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
Lower back pain is one of the most common conditions affecting humans. Lower back supports are a common device used in order to alleviate the pain. All the available back supports are wrapped around the lower back and abdomen and act as static support devices. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Dynamic back support and Static back support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to Apr 2011
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent back pain
- use analgesics
Who cannot join
- Pregnant women
- malignancy
- infection
- neurological condition
- surgical candidate
Trial locations and contacts
1 site in 1 country.
About this study
Lower back pain is one of the most common conditions affecting humans. Lower back supports are a common device used in order to alleviate the pain. All the available back supports are wrapped around the lower back and abdomen and act as static support devices. "The hug" is a new dynamic back support where the participant actively improves his/her posture and strengthens the muscle of the lower back. This trial compares both devices and their effect on reducing lower back pain.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Dynamic back support, Static back support
- Keywords
- back pain, posture, lumbar support, dynamic support
- 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.
Dynamic back supportDevice
Also called hug by Koala
A dynamic back support which provides pressure on the lumbar without pressure on the abdomen
Static back supportDevice
Also called Oppo sacro lumbar support
A standard wrap-around sacro lumbar support
| Study group | Role | What they receive |
|---|---|---|
| Dynamic | Experimental | Use of Dynamic back support Receives: Device: Dynamic back support |
| Static | Active comparator | Use of static back support Receives: Device: Static back support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in back pain
Measured: 3 weeks
Secondary outcomes (1)
Patient satisfaction
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269619
- Sponsor's protocol ID
- HUG-001
- Status last verified
- Dec 2010
- First submitted
- 2 Jan 2011
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Static and Dynamic Back Supports for Lower Back Pain
- ClinicalTrials.gov ID
- NCT01269619
- Acronym / sponsor ID
- HUG-001
- Conditions
- Low Back Pain, Mechanical
- Keywords
- back pain, posture, lumbar support, dynamic support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 4 Jan 2011 (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.
Lower back pain is one of the most common conditions affecting humans. Lower back supports are a common device used in order to alleviate the pain. All the available back supports are wrapped around the lower back and abdomen and act as static support devices. "The hug" is a new dynamic back support where the participant actively improves his/her posture and strengthens the muscle of the lower back. This trial compares both devices and their effect on reducing lower back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic | Experimental | Device: Dynamic back supportUse of Dynamic back support |
| Static | Active comparator | Device: Static back supportUse of static back support |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recurrent back pain
- use analgesics
Key exclusion criteria (5 listed)
- Pregnant women
- malignancy
- infection
- neurological condition
- surgical candidate
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 |
|---|---|---|
| Dynamic back supportAlso: hug by KoalaA dynamic back support which provides pressure on the lumbar without pressure on the abdomen | Device | Dynamic |
| Static back supportAlso: Oppo sacro lumbar supportA standard wrap-around sacro lumbar support | Device | Static |
Primary outcome
Reduction in back pain
Time frame: 3 weeks
1 secondary outcome
Patient satisfaction
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic back support and Static back support in people with Low Back Pain, Mechanical, run by Wolfson Medical Center at 1 site in Israel.
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 2 inclusion and 5 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 4 Jan 2011. 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 Israel. 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?
Contact Yigal Bronstein, M.D. (+972 3 5028453, bronsteiny@wolfson.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in back pain (time frame: 3 weeks). 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 4 Jan 2011.