Status:
RECRUITING
The Nociceptive Flexion Reflex as a Diagnostic Tool of Central Sensitization
Lead Sponsor:
University Ghent
Conditions:
Central Sensitisation
Fibromyalgia
Eligibility:
All Genders
18-65 years
Brief Summary
This experimental study will investigate whether the decreased NFR threshold and increased NFR temporal summation, which are frequently observed in chronic pain patients, are only symptomatic manifest...
Eligibility Criteria
Inclusion
- Inclusion Criteria Fibromyalgia patients:
- \- diagnosed according to 2010 ACR-criteria
- Inclusion Criteria neck pain patients:
- \- having idiopathic neck pain complaints or having grade 1 (pain, stiffness or tenderness of the neck and without objective physical abnormalities) or grade 2 (neck complaints and musculoskeletal disorders such as decreased range of motion and tender pain points) according to the Quebec Task Force on Whiplash Associated Disorders
- Inclusion Criteria low back pain patients:
- \- having idiopathic low back pain complaints
- Inclusion Criteria healthy controls:
- no history of serious pain complaints (e.g. severe migraine, fibromyalgia, etc.)
- no low back or neck pain complaints with an intensity of ≥2/10 on a visual analogue scale in the past year and of such severity that the daily activities were disrupted and a (para)medic was consulted
- Exclusion Criteria:
- history of severe respiratory (e.g. cystic fibrosis), orthopedic (e.g. whiplash trauma), neurological (e.g. cerebrovascular incident), cardiovascular (e.g. severe hypertension), or endocrinological (e.g. diabetes) disorders
- recent psychological trauma (e.g. post-traumatic stress disorder)
- history of spinal surgery (e.g. lumbar discectomy), spinal trauma (e.g. vertebral fracture), or severe spinal deformities (e.g. spondylolisthesis)
- BMI ≥35 (due to potential difficulties in obtaining an NFR in severely overweight individuals)
- having pacemakers and defibrillators (absolute exclusion criteria for electrical stimulus stimulation, i.e. TENS)
- pregnancy, lactation, or within 1 year postpartum
Exclusion
Key Trial Info
Start Date :
April 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05321550
Start Date
April 21 2022
End Date
October 1 2024
Last Update
January 5 2024
Active Locations (1)
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1
Ghent University
Ghent, Belgium