Clinical trial NCT05115461: Neuropathic Pain and Postural Stability in Patients With Lumbar Radiculopathy
Official title: Postural Stability in Patients With Lumbar Radiculopathy and it's Relation to Neuropathic Pain: a Cross Sectional Case-control Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Postural Stability
Balance; Distorted
Neuropathic Pain
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to our outpatient clinic with radicular pain and MRI findings associated with radiculopathy and age- and sex-matched healthy control subjects.

Brief summary: 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.

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.

Primary outcomes:
measure: Dynamic Postural Stability
timeFrame: Once, at baseline
measure: Static Postural Stability
timeFrame: Once, at baseline
Secondary outcomes:
measure: Neuropathic pain
timeFrame: Once, at baseline
measure: Disability
timeFrame: Once, at baseline
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Bozyaka Research and Training Hostpital
Study officials:
affiliation: Bozyaka Training and Research Hospital
name: Bugra Ince, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Health Sciences Izmır Faculty, Bozyaka Training and Research Hospital
name: Taciser Kaya, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.