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

Low Back Pain Clinical Trial

Official title:

Cross Correlation of Pain Hypersensitivity and Clinical and EMG Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979315
• Other study ID #: LK-1
• Status: Completed
• Start date: December 2015
• Est. completion date: May 2021

Study information

• Verified date: November 2021
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Hypersensitivity
• Low Back Pain

Locations

Country	Name	City	State
Serbia	Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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