Neuropathic Pain and Postural Stability in Patients With Lumbar Radiculopathy

NCT05115461 | Enrolling By Invitation

• 1 other identifier: 19663012TCS
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to answer the questions below;

1. 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. 2.Is there a relationship between postural stability and the neuropathic characteristics of radicular pain?

Conditions

Postural Stability; Balance; Distorted; Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

• Dynamic Postural Stability

  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.

  Once, at baseline

• Static Postural Stability

  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.

  Once, at baseline

Secondary Outcomes (2)

• Neuropathic pain

  Once, at baseline

• Disability

  Once, at baseline

Study Arms (2)

Radicular pain group

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

Device: Biodex Balance System™ SD; Other: questionnaires and inventories

Control group

Age- and sex-matched control subjects without pain.

Device: Biodex Balance System™ SD

Interventions

Biodex Balance System™ SD DEVICE

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

Control group; Radicular pain group

questionnaires and inventories OTHER

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

Also known as: physical examination

Radicular pain group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Research and Training Hostpital

Izmir, Turkey (Türkiye)

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Neuralgia

Interventions

Surveys and Questionnaires; Equipment and Supplies; Restraint, Physical

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Officials

• Bugra Ince, MD

  Bozyaka Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Taciser Kaya, Professor

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 10, 2021
• Study Start: November 10, 2021
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)