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Postural StabilityNCT05115461

Neuropathic Pain and Postural Stability in Patients With Lumbar Radiculopathy

An observational study of Postural Stability and Balance; Distorted, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Biodex Balance System™ SD and questionnaires and inventories
Type of treatment
Medical device
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Nov 2021to Jul 2025
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Izmir Bozyaka Research and Training Hostpital

    Izmir

Other trials in Turkey (Türkiye)

About this study

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

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.

Being tested
Biodex Balance System™ SD, questionnaires and inventories
Medical subject headings
Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biodex Balance System™ SDDevice

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

  • questionnaires and inventoriesOther

    Also called physical examination

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

Study groups in NCT05115461
Study groupRoleWhat they receive
Radicular pain groupPatients presenting with lumbar radicular pain and MRI findings associated with radiculopathy
Receives: Device: Biodex Balance System™ SD; Other: questionnaires and inventories
Control groupAge- and sex-matched control subjects without pain.
Receives: Device: Biodex Balance System™ SD

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Once, at baseline

Secondary outcomes (2)

  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.

    Measured: 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).

    Measured: Once, at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2021
  2. Study start10 Nov 2021
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
80 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT05115461
Sponsor's protocol ID
19663012TCS
Status last verified
Oct 2024
First submitted
1 Nov 2021
Last updated
4 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Postural Stability and Balance; Distorted, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dynamic Postural Stability (time frame: Once, at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05115461, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.

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