Clinical trial NCT05223439: Balance and Gait on Neuropathic Pain Due to Lumbar Disc Degeneration
Official title: Investigation of Balance and Gait in Neuropathic Pain Due to Lumbar Disc Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Keywords: Neuropathic Pain
Gait Analysis
Spatio-Temporal Analysis
Foot Pressure Distribution
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Baskent University
First posted: 2022-02-04
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with lumbar disc degeneration and healthy individuals will be included in this study.

Brief summary: Chronic lumbar neuropathic pain, characterized by pain, numbness, tingling and muscle weakness in the lower extremities, is one of the most common neuropathic pain syndromes. It is expected that balance and gait disturbances will occur as a result of motor and sensory problems in patients with neuropathic pain due to lumbar disc degeneration. However, as far as the investigators know, there is no study in the literature describing the effects of neuropathic pain due to lumbar disc degeneration on balance and gait. Therefore, the aim of our study; To examine the effects of neuropathic pain due to lumbar disc degeneration on balance and gait.

Detailed description: Chronic lumbar neuropathic pain, characterized by pain, numbness, tingling and muscle weakness in the lower extremities, is one of the most common neuropathic pain syndromes. Since postural balance is controlled by sensory information, central processing, and neuromuscular responses, any change in proprioception due to prolonged neuropathic pain, asymmetrical load of the lower extremities, timing of dysfunctional muscle activation, sequencing, and asymmetry in foot pressure can alter postural balance. Solid evidence for the long-term effects of lumbar neuropathic pain on postural balance is lacking and needs to be addressed in people with lumbar disc degeneration. Gait problems are seen in patients with lumbar neuropathic pain and they walk more slowly than healthy individuals. However, it is not known to what extent neuropathic pain or neurological dysfunction due to disc degeneration affects gait. In the light of this information; It is expected that balance and gait disturbances will occur as a result of motor and sensory problems in patients with neuropathic pain due to lumbar disc degeneration. However, as far as the investigators know, there is no study in the literature describing the effects of neuropathic pain due to lumbar disc degeneration on balance and gait. Therefore, the aim of our study; To examine the effects of neuropathic pain due to lumbar disc degeneration on balance and gait.

Eligibility criteria: Inclusion criteria for individuals with neuropathic pain due to lumbar disc degeneration:

* Being between the ages of 40-70
* Taking 4 points or more from the Douleur Neuropathique en 4 questions (DN4) questionnaire
* Taking 12 points or more from the Leeds Assessment of Neuropathic Signs and Symptoms (LANSS) scale

Inclusion criteria for individuals with lumbar disc degeneration but no neuropathic pain:

* Being between the ages of 40-70
* Taking below 4 points from the Douleur Neuropathique en 4 questions (DN4) questionnaire
* Taking below 12 points from the Leeds Assessment of Neuropathic Signs and Symptoms (LANSS) scale

Inclusion criteria of healthy individuals in the study:

* Being between the ages of 40-70
* Have no pain (Taking 1 point or less according to the Visual Pain Scale)

Exclusion Criteria:

* Individuals with pain complaints of different etiology
* Individuals with neurological diseases that may cause central neuropathic pain such as stroke, head trauma, multiple sclerosis
* Individuals who have undergone orthopedic surgery in the last 6 months
* Individuals using any medication for neuropathic pain
* Individuals with chronic pain syndrome such as Fibromyalgia Syndrome

Primary outcomes:
measure: E-LINK FP3 Force Plate
timeFrame: Baseline
measure: KoreBalance Balance Evaluation System
timeFrame: Baseline
measure: Gait Velocity
timeFrame: Baseline
measure: Step Length
timeFrame: Baseline
measure: Foot pressure distribution
timeFrame: Baseline
measure: Cadence
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
measure: Douleur Neuropathique 4 Questions (DN4)
timeFrame: Baseline
measure: Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
timeFrame: Baseline
measure: Visual Analog Scale (VAS)
timeFrame: Baseline
measure: Brief Pain Inventory
timeFrame: Baseline
measure: Oswestry Disability Index
timeFrame: Baseline
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
city: Ankara
country: Turkey
facility: Başkent University
Study officials:
affiliation: Hacettepe University
name: Büşra Seçkinoğulları, MSc
role: STUDY_CHAIR
affiliation: Baskent University
name: Zeliha Özlem Yörük, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Atılım University
name: Sibel Kibar, Assoc. Prof.
role: STUDY_CHAIR
affiliation: European University of Lefke
name: Ferdi Yavuz, Assoc.Prof.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Kadriye Armutlu, Prof.
role: STUDY_DIRECTOR
References:
citation: Al Nezari NH, Schneiders AG, Hendrick PA. Neurological examination of the peripheral nervous system to diagnose lumbar spinal disc herniation with suspected radiculopathy: a systematic review and meta-analysis. Spine J. 2013 Jun;13(6):657-74. doi: 10.1016/j.spinee.2013.02.007. Epub 2013 Mar 15.
citation: Khoromi S, Patsalides A, Parada S, Salehi V, Meegan JM, Max MB. Topiramate in chronic lumbar radicular pain. J Pain. 2005 Dec;6(12):829-36. doi: 10.1016/j.jpain.2005.08.002.
citation: Frost LR, Bijman M, Strzalkowski ND, Bent LR, Brown SH. Deficits in foot skin sensation are related to alterations in balance control in chronic low back patients experiencing clinical signs of lumbar nerve root impingement. Gait Posture. 2015 May;41(4):923-8. doi: 10.1016/j.gaitpost.2015.03.345. Epub 2015 Apr 3.
citation: Bonab M, Colak TK, Toktas ZO, Konya D. Assessment of Spatiotemporal Gait Parameters in Patients with Lumbar Disc Herniation and Patients with Chronic Mechanical Low Back Pain. Turk Neurosurg. 2020;30(2):277-284. doi: 10.5137/1019-5149.JTN.27499-19.2.