- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01979315
Cross Correlation of Pain Hypersensitivity and Clinical Features and Electromyography in Low Back Pain Patients
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Belgrade, Serbia, 11000
- Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Low back pain for at least 12 weeks
- Magnetic resonance imaging (MRI) confirmation of prolapsed intervertebral disc (PID)
- No meeting excluding criteria.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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patients with LBP
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healthy individulas
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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
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up to 3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LK-1
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