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

NCT01979315 | Completed

• 1 other identifier: LK-1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

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.

  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

Study Arms (2)

patients with LBP

healthy individulas

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with subacute LBP from tertiary rehabilitation clinic

You may qualify if:

• Low back pain for at least 12 weeks
• Magnetic resonance imaging (MRI) confirmation of prolapsed intervertebral disc (PID)
• No meeting excluding criteria.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

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

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 8, 2013
• Study Start: December 1, 2015
• Primary Completion: January 1, 2021
• Study Completion: May 1, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

SE (1)