Low Back PainNCT01979315
Cross Correlation of Pain Hypersensitivity and Clinical Features and Electromyography in Low Back Pain Patients
An observational study of Low Back Pain, run by University of Belgrade at 1 site in Serbia.
Trial summary
Diagnostic and prognostic value of pain hypersensitivity in low back pain (LBP) is not fully understood.Increased pain sensitivity in the primary area of pain (local pain) is considered a sign of predominantly peripheral pain sensitization,value of pain hypersensitivity in low back pain (LBP)is not fully understood… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 60 participants
- Where
- 1 siteSerbia
- Study dates
- Dec 2015to May 2021
- How long will I take part?
- 5 Days
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with subacute LBP from tertiary rehabilitation clinic
Who may be able to join
- Low back pain for at least 12 weeks
- Magnetic resonance imaging (MRI) confirmation of prolapsed intervertebral disc (PID)
- No meeting excluding criteria.
Who cannot join
- No response to initial contact
- Red flag symptoms
- Diabetes mellitus,
- Neurological problems and
- Cancer
- Pregnant patients
- Patients treated chirurgically for the same problem or treated with oral corticosteroids and steroid injections for any reason in the previous month.
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Belgrade, 11000
About this study
Official title: Cross Correlation of Pain Hypersensitivity and Clinical and EMG Parameters
Diagnostic and prognostic value of pain hypersensitivity in low back pain (LBP) is not fully understood.Increased pain sensitivity in the primary area of pain (local pain) is considered a sign of predominantly peripheral pain sensitization,value of pain hypersensitivity in low back pain (LBP)is not fully understood whereas pain sensitivity in distal and remote areas is considered to present a more central phenomenon. It is suggested that pat ents with enhanced pain sensitivity report high level of disability. Despite fact that pain and disability are associated in chronic LBP the exact mechanisms of sensitivity contribution in LBP disability is unknown. It has also been suggested that muscle function changes may be driven by pain. The possible role and contribution of trunk muscles function to pain and disability phenomena remain unknown.
This study was aimed to estimate prevalence and possible correlation among pain hypersensitivity and functional and electromyography parameters of trunk muscles in patients reporting early phase of chronic LBP.
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| patients with LBP | Not described | |
| healthy individulas | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain hypersensitivity parameters: pain threshold and pressure pain tolerance threshold will be measured by pressure algometer pressure was applied using a probe with an area of 1 cm2 and intensity to a maximum of 1,000 kPa at a rate of 30 kPa/s.
pain detection threshold and pressure pain tolerance threshold (PPTT) )will be measured at the site of maximal pain and of more distant nonpainful point at the back, and the ipsilateral great toe 3 times and average value will be taken for statistics analyses
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startDec 2015
- Primary completionJan 2021
- Study completionMay 2021
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
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinovic Ljubica, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979315
- Sponsor's protocol ID
- LK-1
- Status last verified
- Nov 2021
- First submitted
- 25 Oct 2013
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Correlation of Pain Hypersensitivity and Clinical and EMG Parameters
- ClinicalTrials.gov ID
- NCT01979315
- Acronym / sponsor ID
- LK-1
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 8 Nov 2013 (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.
Diagnostic and prognostic value of pain hypersensitivity in low back pain (LBP) is not fully understood.Increased pain sensitivity in the primary area of pain (local pain) is considered a sign of predominantly peripheral pain sensitization,value of pain hypersensitivity in low back pain (LBP)is not fully understood whereas pain sensitivity in distal and remote areas is considered to present a more central phenomenon. It is suggested that pat ents with enhanced pain sensitivity report high level of disability. Despite fact that pain and disability are associated in chronic LBP the exact mechanisms of sensitivity contribution in LBP disability is unknown. It has also been suggested that muscle function changes may be driven by pain. The possible role and contribution of trunk muscles function to pain and disability phenomena remain unknown.
This study was aimed to estimate prevalence and possible correlation among pain hypersensitivity and functional and electromyography parameters of trunk muscles in patients reporting early phase of chronic LBP.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with LBP | – | – |
| healthy individulas | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with subacute LBP from tertiary rehabilitation clinic
Key inclusion criteria (3 listed)
- Low back pain for at least 12 weeks
- Magnetic resonance imaging (MRI) confirmation of prolapsed intervertebral disc (PID)
- No meeting excluding criteria.
Key exclusion criteria (7 listed)
- No response to initial contact
- Red flag symptoms
- Diabetes mellitus,
- Neurological problems and
- Cancer
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
Pain hypersensitivity parameters: pain threshold and pressure pain tolerance threshold will be measured by pressure algometer pressure was applied using a probe with an area of 1 cm2 and intensity to a maximum of 1,000 kPa at a rate of 30 kPa/s.
Time frame: up to 3 months
pain detection threshold and pressure pain tolerance threshold (PPTT) )will be measured at the site of maximal pain and of more distant nonpainful point at the back, and the ipsilateral great toe 3 times and average value will be taken for statistics analyses
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 16 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 University of Belgrade at 1 site in Serbia.
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 7 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 16 Nov 2021. 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 Serbia. 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?
Pain hypersensitivity parameters: pain threshold and pressure pain tolerance threshold will be measured by pressure algometer pressure was applied using a probe with an area of 1 cm2 and intensity to a maximum of 1,000 kPa at a rate of 30 kPa/s. (time frame: up to 3 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 16 Nov 2021.