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Enrolling by invitation NCT05115461

Neuropathic Pain and Postural Stability in Patients With Lumbar Radiculopathy

— Observational Postural Stability Balance; Distorted Neuropathic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biodex Balance System™ SD, questionnaires and inventories.
Who it may be relevant to
Registry conditions: Postural Stability, Balance; Distorted, Neuropathic Pain. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Postural Stability in Patients With Lumbar Radiculopathy and it's Relation to Neuropathic Pain: a Cross Sectional Case-control Study

Overview

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?

Detailed description

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.

Interventions

  • Device Biodex Balance System™ SD
    Postural stability index values (anteroposterior, mediolateral and overall) will be measured for static and dynamic conditions.
  • Other questionnaires and inventories
    questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.

Primary outcome measures

  • Dynamic Postural Stability [Time frame: Once, at baseline]
  • Static Postural Stability [Time frame: Once, at baseline]
Secondary outcome measures (2)
  • Neuropathic pain [Time frame: Once, at baseline]
  • Disability [Time frame: Once, at baseline]

Eligibility criteria

Inclusion criteria

  • Having radicular pain due to lumbar disc herniation.
  • Root compression on the dominant side on imaging.
  • Root compression at no more than two levels.
  • Radicular pain with at least 3 points on a numerical rating scale.

Exclusion criteria

  • No radicular pain despite root compression on imaging.
  • Midline disc herniation or root compression on the nondominant side.
  • Radicular pain on the non-dominant side.
  • Treatment with neuropathic pain medication or psychotropic medication.
  • Loss of muscle strength on clinical examination.
  • Evidence of lower extremity atrophy, joint contractures, shortening of limbs, or similar disabilities.
  • Presence of vision loss, vestibular or neurological disorders that may cause balance disorders.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Izmir Bozyaka Research and Training Hostpital — Izmir

Publications

  • Lin SI, Lin RM. Sensorimotor and balance function in older adults with lumbar nerve root compression. Clin Orthop Relat Res. 2002 Jan;(394):146-53. doi: 10.1097/00003086-200201000-00017. PMID 11795726
  • Kim KH, Leem MJ, Yi TI, Kim JS, Yoon SY. Balance Ability in Low Back Pain Patients With Lumbosacral Radiculopathy Evaluated With Tetrax: A Matched Case-Control Study. Ann Rehabil Med. 2020 Jun;44(3):195-202. doi: 10.5535/arm.19101. Epub 2020 May 29. PMID 32475097
  • Sipko T, Kuczynski M. Intensity of chronic pain modifies postural control in low back patients. Eur J Pain. 2013 Apr;17(4):612-20. doi: 10.1002/j.1532-2149.2012.00226.x. PMID 23065907
  • Tsigkanos C, Gaskell L, Smirniotou A, Tsigkanos G. Static and dynamic balance deficiencies in chronic low back pain. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):887-893. doi: 10.3233/BMR-160721. PMID 27341640
  • Brech GC, Andrusaitis SF, Vitale GF, Greve JM. Correlation of disability and pain with postural balance among women with chronic low back pain. Clinics (Sao Paulo). 2012 Aug;67(8):959-62. doi: 10.6061/clinics/2012(08)17. No abstract available. PMID 22948466

Identifiers

NCT: NCT05115461 · 19663012TCS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗