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Enrolling by invitationNCT05115461Updated Nov 4, 2024

Neuropathic Pain and Postural Stability in Patients With Lumbar Radiculopathy

An observational study in Postural Stability, Balance; Distorted and Neuropathic Pain, sponsored by Bozyaka Training and Research Hospital. Enrolling by invitation at 1 site in Turkey. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-04.

Sponsored by Bozyaka Training and Research Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
80
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 79 studies in Neuralgia with a site in Turkey — 30 open to participants now, 31 under way, none of them phase 3. Neuralgia · Turkey.

Planned enrollment
27th of 43
80 · median 96
Started
2021
with 8 others
Observational
43 of 79
16 open now
Primary completion
2025-07
later than 3 of 30 live
Registered
17th of 79
by date
Lead sponsor
2 of 79
Bozyaka Training and Research Hospital

Among the 79 studies in Neuralgia with a site in Turkey, this one is the 27th largest by planned enrollment of the 43 observational ones, is one of 9 that started in 2021, is one of 43 observational ones, reaches primary completion later than 3 of the 30 other live ones, and was the 17th registered.

By phase

79 studies; the count open now beside each. This study's row is marked.

Observationalthis study43 · 16 open
No phase36 · 14 open

By the year they started

First in 2010; this study’s year is marked. 9 started in 2021.

Size and results

Median enrollment 60 across the 36 interventional studies, 96 across the 43 observational. Of the 41 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 79 studies in Neuralgia with a site in Turkey, or all of them as a file.
02

Study 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?
Read the 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.

03

Conditions studied

  • Postural Stability
  • Balance; Distorted
  • Neuropathic Pain

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04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

  • DeviceBiodex Balance System™ SD

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

  • Otherquestionnaires and inventories

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

    Also known as: physical examination

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Once, at baseline

  2. 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.

    Time frame: Once, at baseline

Secondary outcomes

  1. Neuropathic pain

    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

  2. Disability

    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).

    Time frame: Once, at baseline

07

Study locations

1 site
  • Izmir Bozyaka Research and Training Hostpital
    İzmir, Turkey
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 22948466 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2021 (actual). Primary completion is estimated for Jul 2025, 44 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2021
First posted
Nov 10, 2021
StartActual
Nov 10, 2021
Primary completionEst.
Jul 2025
CompletionEst.
Jul 2025
Last update
Nov 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05115461
Lead sponsor
Bozyaka Training and Research Hospital
Responsible party
Buğra İnce (Assoc. Prof, Bozyaka Training and Research Hospital) — Principal investigator
First posted
Nov 10, 2021
Start date
Nov 10, 2021
Primary completion
Jul 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Nov 4, 2024

Study contacts

Bugra Ince, MD
principal investigator · Bozyaka Training and Research Hospital
Taciser Kaya, Professor
study director · University of Health Sciences Izmır Faculty, Bozyaka Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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