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).
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
- Conditions the study is for
- Postural Stability, Balance; Distorted, Neuropathic Pain
- 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
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. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Izmir Bozyaka Research and Training Hostpital
Izmir
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;
- Is there a difference between patients with lumbar radiculopathy suffering from radicular pain and healthy subjects in terms of static and dynamic postural stability?
- 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.
- Conditions
- Postural Stability, Balance; Distorted, Neuropathic Pain
- 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 group | Role | What they receive |
|---|---|---|
| Radicular pain group | Patients presenting with lumbar radicular pain and MRI findings associated with radiculopathy Receives: Device: Biodex Balance System™ SD; Other: questionnaires and inventories | |
| Control group | Age- 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.
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
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)
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
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.
- First posted10 Nov 2021
- Study start10 Nov 2021
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postural StabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buğra İnce, Bozyaka Training and Research Hospital
- Investigators
- Bugra Ince, MD, Principal investigator, Bozyaka Training and Research HospitalTaciser Kaya, Professor, Study director, University of Health Sciences Izmır Faculty, Bozyaka Training and Research Hospital
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 11795726Kim 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 32475097Sipko 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 23065907Tsigkanos 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 27341640Brech 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