Balance and Gait on Neuropathic Pain Due to Lumbar Disc Degeneration

NCT05223439 | Completed

• 1 other identifier: KA21/489
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Neuropathic Pain

Keywords

Neuropathic Pain; Gait Analysis; Spatio-Temporal Analysis; Foot Pressure Distribution

Outcome Measures

Primary Outcomes (6)

• E-LINK FP3 Force Plate

  Measuring the symmetrical weight distribution in the anterior-posterior and left-right axes, the system enables the assessment of the ability to maintain postural stability on a static surface. While the patient is standing on the force platform, determine which direction the balance has shifted.

  Baseline

• KoreBalance Balance Evaluation System

  The KoreBalance balance evaluation platform has a variable air pressure bag system and tilt sensor to monitor 360° horizontal and 20° vertical movements.

  Baseline

• Gait Velocity

  Zebris Rehawalk computerized gait evaluation system is used to assess the spatio-temporal characteristics of the gait. The system consists of a treadmill and a computer. While the computer automatically detects the patient's hip, knee, and ankle, measures an individual's foot pressure on the ground. For gait assessment, patients walk at their preferred comfortable walking speed.

  Baseline

• Step Length

  Zebris Rehawalk computerized gait assessment system is used to evaluate the spatio-temporal characteristics of gait and to perform kinetic-kinematic analysis.

  Baseline

• Foot pressure distribution

  The dynamic foot pressure distribution is analyzed with the pedobarography integrated into Zebris Rehawalk computerized gait assessment system. The system consists of a treadmill and a computer. While the computer automatically detects the patient's hip, knee, and ankle, measures an individual's foot pressure on the ground. For gait assessment, patients walk at their preferred comfortable walking speed.

  Baseline

• Cadence

  Zebris Rehawalk computerized gait evaluation system is used to assess the spatio-temporal characteristics of the gait. The system consists of a treadmill and a computer. While the computer automatically detects the patient's hip, knee, and ankle, measures an individual's foot pressure on the ground. For gait assessment, patients walk at their preferred comfortable walking speed.

  Baseline

Other Outcomes (5)

• Douleur Neuropathique 4 Questions (DN4)

  Baseline

• Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)

  Baseline

• Visual Analog Scale (VAS)

  Baseline

Study Arms (3)

Individuals diagnosed with neuropathic pain due to lumbar disc degeneration

Individuals with neuropathic pain due to lumbar disc degeneration were included in this group.

Individuals with lumbar disc degeneration but no neuropathic pain

Individuals without neuropathic pain due to lumbar disc degeneration were included in this group.

Healthy Controls

Healthy individuals who did not have any problems that would affect gait were included.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with lumbar disc degeneration and healthy individuals will be included in this study.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead
• Baskent University: collaborator

Study Sites (2)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Başkent University

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 23499340 BACKGROUND

• 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.

  PMID: 16326371 BACKGROUND

• 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.

  PMID: 25887249 BACKGROUND

• 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.

  PMID: 32091127 BACKGROUND

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Büşra Seçkinoğulları, MSc

  Hacettepe University

  STUDY CHAIR

• Zeliha Özlem Yörük, Assoc. Prof.

  Baskent University

  STUDY CHAIR

• Sibel Kibar, Assoc. Prof.

  Atılım University

  STUDY CHAIR

• Ferdi Yavuz, Assoc.Prof.

  European University of Lefke

  STUDY CHAIR

• Kadriye Armutlu, Prof.

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 4, 2022
• Study Start: January 5, 2022
• Primary Completion: August 1, 2023
• Study Completion: February 1, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)