Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain
NCT03848143
Nervous System Diseases, Neuralgia
Lexington, Kentucky, United States
View Trial DetailsNCT Number: NCT05223439
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.
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Notify Me40 year–70 year
All sexes
Observational
Başkent University, Ankara, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for individuals with neuropathic pain due to lumbar disc degeneration:
Inclusion criteria
for individuals with lumbar disc degeneration but no neuropathic pain:
Inclusion criteria
of healthy individuals in the study:
Exclusion criteria
Time frame: Baseline
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.
Time frame: Baseline
The KoreBalance balance evaluation platform has a variable air pressure bag system and tilt sensor to monitor 360° horizontal and 20° vertical movements.
Time frame: Baseline
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.
Time frame: Baseline
Zebris Rehawalk computerized gait assessment system is used to evaluate the spatio-temporal characteristics of gait and to perform kinetic-kinematic analysis.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Hacettepe University
Other
Investigation of Balance and Gait in Neuropathic Pain Due to Lumbar Disc Degeneration
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