Izmir Bozyaka Research and Training Hostpital
Izmir, Turkey (Türkiye)
NCT Number: NCT05115461
The aim of this study is to answer the questions below;
1. Is there a difference between patients with lumbar radiculopathy suffering from radicular pain and healthy subjects in terms of static and dynamic postural stability? 2. Is there a relationship between postural stability and the neuropathic characteristics of radicular pain?
Interested in participating?
Request Info18 year–60 year
All sexes
Observational
Izmir, Turkey (Türkiye)
Patients presenting to our outpatient clinic with radicular pain and MRI findings associated with radiculopathy will be tested for static and dynamic postural stability. Patient demographics, pain intensity, neuropathic pain scores, and level of disability will also be recorded. The demographic data and postural stability scores will also be collected for the control subjects. Differences between the patient and control groups in terms of postural stability parameters will be sought. In addition, the relationship between the variables representing balance in the patient group and the neuropathic pain score and disability will be investigated.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Postural stability index values (anteroposterior, mediolateral and overall) will be measured for static and dynamic conditions.
questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.
Other names: physical examination
Time frame: Once, at baseline
Postural Stability Test will be performed via Biodex Balance System. This test assesses the patient's ability to maintain the center position (zero point) on a moving balance platform. The test protocol is performed with the following parameters: Duration: 20 seconds, Stability Level: 8, and Stance: two legs. Patients will complete a 1-minute pre-test trial to get used to the device. Then the test will be performed with 3 trials. The patient's performance will be noted as the overall stability index. A high stability index value indicates poor balance and stability.
Time frame: Once, at baseline
Postural Stability Test will be performed via Biodex Balance System. This test assesses the patient's ability to maintain the center position (zero point) on a stable platform. The test protocol is performed with the following parameters: Duration: 20 seconds, Stability Level: Static, and Stance: both legs, alternating. Patients will complete a 1-minute pre-test trial to get used to the device. Then the test will be performed with 3 trials. The patient's performance will be noted as the overall stability index. A high stability index value indicates poor balance and stability.
Time frame: Once, at baseline
It will be assessed using the painDETECT questionnaire. The PainDETECT questionnaire contains nine questions, all based on self-assessment. Seven items are rated on a six-point Likert scale, ranging from 0-5. These seven questions query some sensations such as burning, tingling or prickling, allodynia, numbness, etc. Apart from these seven items, one item assesses the radiation of pain and another item asks about the temporal characteristics of pain. A total score of 12 or less indicates neuropathic component is unlikely, 13-18 means a possible neuropathic component and 19 or greater means that a neuropathic component is likely. In addition, there are three items in a separate section that measure the severity of pain at the time of assessment, on average, and at most in the last month. This section is not included in the assessment.
Time frame: Once, at baseline
It will be assessed using Quebec Back Pain Disability Scale. This scale contains 6 domains of activity affected by back pain: bed/rest (items 1-3), sitting/standing (items 4-6), ambulation (items 7-9), movement (items 10-12), bending/stooping (items 13-16), and handling of large/heavy objects (items 17-20). For each item, a 6-point Likert scale (0-5) to indicate the level of difficulty is used, where 0 = "not difficult at all," 1 = "minimally difficult," 2 = "somewhat difficult," 3 = "fairly difficult," 4 = "very difficult," and 5 = "unable to do." The total score is calculated by adding up the scores of each items. Scores range from 0 (no disability) to 100 (maximal disability).
Bozyaka Training and Research Hospital
Other
Postural Stability in Patients With Lumbar Radiculopathy and it's Relation to Neuropathic Pain: a Cross Sectional Case-control Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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