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NCT Number: NCT01979315

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade

Belgrade, 11000, Serbia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

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Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Registry information

Official study title

Cross Correlation of Pain Hypersensitivity and Clinical and EMG Parameters

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Nov 8, 2013
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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