Cross Correlation of Pain Hypersensitivity and Clinical Features and Electromyography in Low Back Pain Patients

November 12, 2021 updated by: Konstantinovic Ljubica, University of Belgrade

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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with subacute LBP from tertiary rehabilitation clinic

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients with LBP
healthy individulas

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
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
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Belgrade

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2015

Primary Completion (ACTUAL)

January 1, 2021

Study Completion (ACTUAL)

May 1, 2021

Study Registration Dates

First Submitted

October 25, 2013

First Submitted That Met QC Criteria

October 31, 2013

First Posted (ESTIMATE)

November 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LK-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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