Neuropathic Pain and Postural Stability in Patients With Lumbar Radiculopathy

NCT ID: NCT05115461

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-10

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

Conditions

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Postural Stability Balance; Distorted Neuropathic Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Radicular pain group

Patients presenting with lumbar radicular pain and MRI findings associated with radiculopathy

Biodex Balance System™ SD

Intervention Type DEVICE

Postural stability index values (anteroposterior, mediolateral and overall) will be measured for static and dynamic conditions.

questionnaires and inventories

Intervention Type OTHER

questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.

Control group

Age- and sex-matched control subjects without pain.

Biodex Balance System™ SD

Intervention Type DEVICE

Postural stability index values (anteroposterior, mediolateral and overall) will be measured for static and dynamic conditions.

Interventions

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Biodex Balance System™ SD

Postural stability index values (anteroposterior, mediolateral and overall) will be measured for static and dynamic conditions.

Intervention Type DEVICE

questionnaires and inventories

questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.

Intervention Type OTHER

Other Intervention Names

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physical examination

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bozyaka Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Buğra İnce

Assoc. Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bugra Ince, MD

Role: PRINCIPAL_INVESTIGATOR

Bozyaka Training and Research Hospital

Taciser Kaya, Professor

Role: STUDY_DIRECTOR

University of Health Sciences Izmır Faculty, Bozyaka Training and Research Hospital

Locations

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Izmir Bozyaka Research and Training Hostpital

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 11795726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32475097 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23065907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27341640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22948466 (View on PubMed)

Other Identifiers

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19663012TCS

Identifier Type: -

Identifier Source: org_study_id

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