Neuropathic PainNCT05223439
Balance and Gait on Neuropathic Pain Due to Lumbar Disc Degeneration
An observational study of Neuropathic Pain, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial summary
Chronic lumbar neuropathic pain, characterized by pain, numbness, tingling and muscle weakness in the lower extremities, is one of the most common neuropathic pain syndromes. It is expected that balance and gait disturbances will occur as a result of motor and sensory problems in patients with neuropathic pain due to… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain
- How many people
- 42 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Jan 2022to 1 Feb 2024
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with lumbar disc degeneration and healthy individuals will be included in this study.
Who may be able to join
- Being between the ages of 40-70
- Have no pain (Taking 1 point or less according to the Visual Pain Scale)
Who cannot join
- Individuals with pain complaints of different etiology
- Individuals with neurological diseases that may cause central neuropathic pain such as stroke, head trauma, multiple sclerosis
- Individuals who have undergone orthopedic surgery in the last 6 months
- Individuals using any medication for neuropathic pain
- Individuals with chronic pain syndrome such as Fibromyalgia Syndrome
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hacettepe University
Ankara, 06100
Başkent University
Ankara
About this study
Official title: Investigation of Balance and Gait in Neuropathic Pain Due to Lumbar Disc Degeneration
Chronic lumbar neuropathic pain, characterized by pain, numbness, tingling and muscle weakness in the lower extremities, is one of the most common neuropathic pain syndromes. It is expected that balance and gait disturbances will occur as a result of motor and sensory problems in patients with neuropathic pain due to lumbar disc degeneration. However, as far as the investigators know, there is no study in the literature describing the effects of neuropathic pain due to lumbar disc degeneration on balance and gait. Therefore, the aim of our study; To examine the effects of neuropathic pain due to lumbar disc degeneration on balance and gait.
Read the detailed description
Chronic lumbar neuropathic pain, characterized by pain, numbness, tingling and muscle weakness in the lower extremities, is one of the most common neuropathic pain syndromes. Since postural balance is controlled by sensory information, central processing, and neuromuscular responses, any change in proprioception due to prolonged neuropathic pain, asymmetrical load of the lower extremities, timing of dysfunctional muscle activation, sequencing, and asymmetry in foot pressure can alter postural balance. Solid evidence for the long-term effects of lumbar neuropathic pain on postural balance is lacking and needs to be addressed in people with lumbar disc degeneration. Gait problems are seen in patients with lumbar neuropathic pain and they walk more slowly than healthy individuals. However, it is not known to what extent neuropathic pain or neurological dysfunction due to disc degeneration affects gait. In the light of this information; It is expected that balance and gait disturbances will occur as a result of motor and sensory problems in patients with neuropathic pain due to lumbar disc degeneration. However, as far as the investigators know, there is no study in the literature describing the effects of neuropathic pain due to lumbar disc degeneration on balance and gait. Therefore, the aim of our study; To examine the effects of neuropathic pain due to lumbar disc degeneration on balance and gait.
- Conditions
- Neuropathic Pain
- Keywords
- Neuropathic Pain, Gait Analysis, Spatio-Temporal Analysis, Foot Pressure Distribution
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals diagnosed with neuropathic pain due to lumbar disc degeneration | Individuals with neuropathic pain due to lumbar disc degeneration were included in this group. | |
| Individuals with lumbar disc degeneration but no neuropathic pain | Individuals without neuropathic pain due to lumbar disc degeneration were included in this group. | |
| Healthy Controls | Healthy individuals who did not have any problems that would affect gait were included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
E-LINK FP3 Force Plate
Measuring the symmetrical weight distribution in the anterior-posterior and left-right axes, the system enables the assessment of the ability to maintain postural stability on a static surface. While the patient is standing on the force platform, determine which direction the balance has shifted.
Measured: Baseline
KoreBalance Balance Evaluation System
The KoreBalance balance evaluation platform has a variable air pressure bag system and tilt sensor to monitor 360° horizontal and 20° vertical movements.
Measured: Baseline
Gait Velocity
Zebris Rehawalk computerized gait evaluation system is used to assess the spatio-temporal characteristics of the gait. The system consists of a treadmill and a computer. While the computer automatically detects the patient's hip, knee, and ankle, measures an individual's foot pressure on the ground. For gait assessment, patients walk at their preferred comfortable walking speed.
Measured: Baseline
Step Length
Zebris Rehawalk computerized gait assessment system is used to evaluate the spatio-temporal characteristics of gait and to perform kinetic-kinematic analysis.
Measured: Baseline
Foot pressure distribution
The dynamic foot pressure distribution is analyzed with the pedobarography integrated into Zebris Rehawalk computerized gait assessment system. The system consists of a treadmill and a computer. While the computer automatically detects the patient's hip, knee, and ankle, measures an individual's foot pressure on the ground. For gait assessment, patients walk at their preferred comfortable walking speed.
Measured: Baseline
Cadence
Zebris Rehawalk computerized gait evaluation system is used to assess the spatio-temporal characteristics of the gait. The system consists of a treadmill and a computer. While the computer automatically detects the patient's hip, knee, and ankle, measures an individual's foot pressure on the ground. For gait assessment, patients walk at their preferred comfortable walking speed.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start5 Jan 2022
- Primary completion1 Aug 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University
- Responsible party
- Principal investigator, Suleyman Korkusuz, Hacettepe University
- Investigators
- Büşra Seçkinoğulları, MSc, Study chair, Hacettepe UniversityZeliha Özlem Yörük, Assoc. Prof., Study chair, Baskent UniversitySibel Kibar, Assoc. Prof., Study chair, Atılım UniversityFerdi Yavuz, Assoc.Prof., Study chair, European University of LefkeKadriye Armutlu, Prof., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223439
- Sponsor's protocol ID
- KA21/489
- Status last verified
- Mar 2024
- First submitted
- 21 Jan 2022
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al Nezari NH, Schneiders AG, Hendrick PA. Neurological examination of the peripheral nervous system to diagnose lumbar spinal disc herniation with suspected radiculopathy: a systematic review and meta-analysis. Spine J. 2013 Jun;13(6):657-74. doi: 10.1016/j.spinee.2013.02.007. Epub 2013 Mar 15.
PubMed 23499340Khoromi S, Patsalides A, Parada S, Salehi V, Meegan JM, Max MB. Topiramate in chronic lumbar radicular pain. J Pain. 2005 Dec;6(12):829-36. doi: 10.1016/j.jpain.2005.08.002.
PubMed 16326371Frost LR, Bijman M, Strzalkowski ND, Bent LR, Brown SH. Deficits in foot skin sensation are related to alterations in balance control in chronic low back patients experiencing clinical signs of lumbar nerve root impingement. Gait Posture. 2015 May;41(4):923-8. doi: 10.1016/j.gaitpost.2015.03.345. Epub 2015 Apr 3.
PubMed 25887249Bonab M, Colak TK, Toktas ZO, Konya D. Assessment of Spatiotemporal Gait Parameters in Patients with Lumbar Disc Herniation and Patients with Chronic Mechanical Low Back Pain. Turk Neurosurg. 2020;30(2):277-284. doi: 10.5137/1019-5149.JTN.27499-19.2.
PubMed 32091127
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Balance and Gait in Neuropathic Pain Due to Lumbar Disc Degeneration
- ClinicalTrials.gov ID
- NCT05223439
- Acronym / sponsor ID
- KA21/489
- Conditions
- Neuropathic Pain
- Keywords
- Neuropathic Pain, Gait Analysis, Spatio-Temporal Analysis, Foot Pressure Distribution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Baskent University
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic lumbar neuropathic pain, characterized by pain, numbness, tingling and muscle weakness in the lower extremities, is one of the most common neuropathic pain syndromes. It is expected that balance and gait disturbances will occur as a result of motor and sensory problems in patients with neuropathic pain due to lumbar disc degeneration. However, as far as the investigators know, there is no study in the literature describing the effects of neuropathic pain due to lumbar disc degeneration on balance and gait. Therefore, the aim of our study; To examine the effects of neuropathic pain due to lumbar disc degeneration on balance and gait.
Detailed description
Chronic lumbar neuropathic pain, characterized by pain, numbness, tingling and muscle weakness in the lower extremities, is one of the most common neuropathic pain syndromes. Since postural balance is controlled by sensory information, central processing, and neuromuscular responses, any change in proprioception due to prolonged neuropathic pain, asymmetrical load of the lower extremities, timing of dysfunctional muscle activation, sequencing, and asymmetry in foot pressure can alter postural balance. Solid evidence for the long-term effects of lumbar neuropathic pain on postural balance is lacking and needs to be addressed in people with lumbar disc degeneration. Gait problems are seen in patients with lumbar neuropathic pain and they walk more slowly than healthy individuals. However, it is not known to what extent neuropathic pain or neurological dysfunction due to disc degeneration affects gait. In the light of this information; It is expected that balance and gait disturbances will occur as a result of motor and sensory problems in patients with neuropathic pain due to lumbar disc degeneration. However, as far as the investigators know, there is no study in the literature describing the effects of neuropathic pain due to lumbar disc degeneration on balance and gait. Therefore, the aim of our study; To examine the effects of neuropathic pain due to lumbar disc degeneration on balance and gait.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individuals diagnosed with neuropathic pain due to lumbar disc degeneration | – | –Individuals with neuropathic pain due to lumbar disc degeneration were included in this group. |
| Individuals with lumbar disc degeneration but no neuropathic pain | – | –Individuals without neuropathic pain due to lumbar disc degeneration were included in this group. |
| Healthy Controls | – | –Healthy individuals who did not have any problems that would affect gait were included. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with lumbar disc degeneration and healthy individuals will be included in this study.
Key inclusion criteria (2 listed)
- Being between the ages of 40-70
- Have no pain (Taking 1 point or less according to the Visual Pain Scale)
Key exclusion criteria (5 listed)
- Individuals with pain complaints of different etiology
- Individuals with neurological diseases that may cause central neuropathic pain such as stroke, head trauma, multiple sclerosis
- Individuals who have undergone orthopedic surgery in the last 6 months
- Individuals using any medication for neuropathic pain
- Individuals with chronic pain syndrome such as Fibromyalgia Syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
E-LINK FP3 Force Plate
Time frame: Baseline
Measuring the symmetrical weight distribution in the anterior-posterior and left-right axes, the system enables the assessment of the ability to maintain postural stability on a static surface. While the patient is standing on the force platform, determine which direction the balance has shifted.
KoreBalance Balance Evaluation System
Time frame: Baseline
The KoreBalance balance evaluation platform has a variable air pressure bag system and tilt sensor to monitor 360° horizontal and 20° vertical movements.
Gait Velocity
Time frame: Baseline
Zebris Rehawalk computerized gait evaluation system is used to assess the spatio-temporal characteristics of the gait. The system consists of a treadmill and a computer. While the computer automatically detects the patient's hip, knee, and ankle, measures an individual's foot pressure on the ground. For gait assessment, patients walk at their preferred comfortable walking speed.
Step Length
Time frame: Baseline
Zebris Rehawalk computerized gait assessment system is used to evaluate the spatio-temporal characteristics of gait and to perform kinetic-kinematic analysis.
Foot pressure distribution
Time frame: Baseline
The dynamic foot pressure distribution is analyzed with the pedobarography integrated into Zebris Rehawalk computerized gait assessment system. The system consists of a treadmill and a computer. While the computer automatically detects the patient's hip, knee, and ankle, measures an individual's foot pressure on the ground. For gait assessment, patients walk at their preferred comfortable walking speed.
Cadence
Time frame: Baseline
Zebris Rehawalk computerized gait evaluation system is used to assess the spatio-temporal characteristics of the gait. The system consists of a treadmill and a computer. While the computer automatically detects the patient's hip, knee, and ankle, measures an individual's foot pressure on the ground. For gait assessment, patients walk at their preferred comfortable walking speed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 23499340Al Nezari NH, Schneiders AG, Hendrick PA. Neurological examination of the peripheral nervous system to diagnose lumbar spinal disc herniation with suspected radiculopathy: a systematic review and meta-analysis. Spine J. 2013 Jun;13(6):657-74. doi: 10.1016/j.spinee.2013.02.007. Epub 2013 Mar 15.
- Background: PubMed 16326371Khoromi S, Patsalides A, Parada S, Salehi V, Meegan JM, Max MB. Topiramate in chronic lumbar radicular pain. J Pain. 2005 Dec;6(12):829-36. doi: 10.1016/j.jpain.2005.08.002.
- Background: PubMed 25887249Frost LR, Bijman M, Strzalkowski ND, Bent LR, Brown SH. Deficits in foot skin sensation are related to alterations in balance control in chronic low back patients experiencing clinical signs of lumbar nerve root impingement. Gait Posture. 2015 May;41(4):923-8. doi: 10.1016/j.gaitpost.2015.03.345. Epub 2015 Apr 3.
- Background: PubMed 32091127Bonab M, Colak TK, Toktas ZO, Konya D. Assessment of Spatiotemporal Gait Parameters in Patients with Lumbar Disc Herniation and Patients with Chronic Mechanical Low Back Pain. Turk Neurosurg. 2020;30(2):277-284. doi: 10.5137/1019-5149.JTN.27499-19.2.
- Individual participant dataSharing planned: No
Related trials for Neuropathic Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Büşra Seçkinoğulları, MSc study chair
Hacettepe University
Zeliha Özlem Yörük, Assoc. Prof. study chair
Baskent University
Sibel Kibar, Assoc. Prof. study chair
Atılım University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by Hacettepe University at 2 sites 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
E-LINK FP3 Force Plate (time frame: Baseline). The study lists 6 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 NCT05223439, which also lists 4 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 2 Apr 2024.