Balance and Gait on Neuropathic Pain Due to Lumbar Disc Degeneration

Neuropathic Pain Clinical Trial

Official title:

Investigation of Balance and Gait in Neuropathic Pain Due to Lumbar Disc Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05223439
• Other study ID #: KA21/489
• Status: Completed
• Start date: January 5, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Neuralgia
• Neuropathic Pain

Locations

Country	Name	City	State
Turkey	Baskent University	Ankara
Turkey	Hacettepe University	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Baskent University

Country where clinical trial is conducted

Turkey, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Douleur Neuropathique 4 Questions (DN4)	DN4 is a scale consisting of 10 questions evaluating neuropathic pain. Seven items are related to pain symptoms and three items include a clinical examination. The scale asks whether patients have burning, painful cold, electric shock, tingling, prickling, numbness, and itching. In addition, sensory changes in the patient are examined with cotton, pins, and brushing. While 1 point is given for each item in scoring, a score of 4 or more indicates the presence of neuropathic pain. Taking 4 points or more from the DN4 is one of the criteria for identifying neuropathic pain in the study.	Baseline
Other	Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)	The LANSS is a validated questionnaire that consists of 7 items, can distinguish neuropathic pain from nociceptive pain, and is easy to score in clinical settings. The first part of the scale consists of 5 items questioning the pain symptoms and answered as yes or no. The patient is asked to think about the pain he or she has felt during the past week. In the second part, the presence of allodynia and the sharp-blunt threshold value is evaluated by sensory examination. The questionnaire is calculated between 0-24 points. Twelve points and above indicates neuropathic pain. Taking below 12 points from the LANSS scale is one of the criteria for identifying neuropathic pain in the study.	Baseline
Other	Visual Analog Scale (VAS)	Visual Analog Scale is a scale that evaluates pain on a horizontal line. On the line, the left side indicates 'no pain' and the right side indicates 'the most severe pain imaginable. Healthy individuals are asked to mark a point on the line according to the severity of the pain they feel.	Baseline
Other	Brief Pain Inventory	This inventory includes the recording of the clinical information of the patients and the evaluation of their pain, and the pain, the severity of the pain, the character of the pain, the treatment methods applied against the pain, the results of these methods and their social-emotional effects are recorded.	Baseline
Other	Oswestry Disability Index	It is an index that measures the level of functional disability of individuals due to pain. It includes ten sub-headings: severity of pain, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life and travel. Each question is scored between 0 and 5. Scores ranging from 0-50 are converted into a percentage value with a special formula according to the number of questions answered. The functional status worsens as the percentage increases.	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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