RadiculopathyNCT06001359
Functional Limitation, Pain and Quality of Life in Patients With Cervical Spondylotic Radiculopathy
An observational study of Radiculopathy and Elderly, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Radiculopathy is a neurological condition in which transmission along a spinal nerve and its roots is limited or inhibited. It is most caused by spondylotic changes such as cervical disc herniation leading to nerve root compression, inflammatory changes, and the formation of bony prominences in this region [1]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiculopathy, Elderly
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Dec 2023to 30 Apr 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 18 years and older
- All sexes
- Adult, Older adult
Study population: 64 patients with spondylotic radiculopathy will be included.
Who may be able to join
- over 18 years of age
- with lateral-foraminal spinal stenosis in the cervical region
- with or without neck pain consistent with the diagnosis obtained from magnetic resonance imaging
- with unilateral root symptoms such as pain, numbness, weakness in the affected limb, and diagnosis based on MRI and computerized tomography
Who cannot join
- signs of increased ventral pressure, such as ventral osteophytes, disc calcification, and ligament hypertrophy
- severe neurological deficits, pregnant women, spinal malignancies,
- those who had undergone cervical surgery in the last 12 months
- and those who could not cooperate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karabuk University
Karabük
Aydın Sinan Apaydın, PhD, +905065897613, dr.sinanapaydin@yahoo.com
About this study
Official title: Functional Limitation, Pain, Disability and Quality of Life in Patients With Cervical Spondylotic Radiculopathy
Radiculopathy is a neurological condition in which transmission along a spinal nerve and its roots is limited or inhibited. It is most caused by spondylotic changes such as cervical disc herniation leading to nerve root compression, inflammatory changes, and the formation of bony prominences in this region [1]. Pain is the initial symptom and cervical radiculopathy should be suspected when pain radiates from the neck to the shoulder and arm, accompanied by sensory complaints and motor weakness. It is most commonly caused by spondylotic changes, such as cervical disc herniation and bony prominences in this area, leading to nerve root compression and inflammatory changes. Stenotic changes in the spine, which are often observed with aging, can cause nerve damage and compression in individuals, causing radicular pain. However, there is insufficient study in which the relationship between pain caused by cervical spondylotic radiculopathy caused by stenosis and functional disability, disability and quality of life due to radiculopathy in patients is insufficient. In addition, the lack of a comprehensive outcome scale that evaluates the functional limitation caused by radicular pain has also led to a deficiency in the evaluation of functional limitation. In this context, CRES is a newly developed scale used to evaluate functional limitation associated with radicular pain. In this context, in this study, it was aimed to examine the relationship between pain, functional disability, disability and quality of life in patients with cervical spondylotic radiculopathy.
- Conditions
- Radiculopathy, Elderly
- Being tested
- No intervention
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck/Arm Pain
A numeric rating scale will be used to evaluate neck and arm pain severity.
Measured: baseline
Funcitonal disability
The Cervical Radiculopathy Impact Scale (CRIS) will used to determine the functional limitation.
Measured: baseline
Disability
Neck Disability Index (NDI) will used to evaluate the effect of neck pain on activities of daily living
Measured: baseline
life quality
The EuroQol Five-Dimensions - 3-Level (EQ-5D-3L) General Quality of Life Scale will used to evaluate the quality of life of individuals
Measured: baseline
Severity of stenosis
The severity of stenosis will be evaluated with MRI.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start27 Dec 2023
- Primary completion15 Mar 2024
- Study completion30 Apr 2024 (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 RadiculopathyStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aydın Sinan Apaydin, Karabuk University
- Investigators
- Aydın Sinan Apaydın, PhD, Study director, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001359
- Sponsor's protocol ID
- radiculopathy
- Status last verified
- Mar 2024
- First submitted
- 14 Aug 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thoomes EJ, Scholten-Peeters GG, de Boer AJ, Olsthoorn RA, Verkerk K, Lin C, Verhagen AP. Lack of uniform diagnostic criteria for cervical radiculopathy in conservative intervention studies: a systematic review. Eur Spine J. 2012 Aug;21(8):1459-70. doi: 10.1007/s00586-012-2297-9. Epub 2012 Apr 25.
PubMed 22531897Patel EA, Perloff MD. Radicular Pain Syndromes: Cervical, Lumbar, and Spinal Stenosis. Semin Neurol. 2018 Dec;38(6):634-639. doi: 10.1055/s-0038-1673680. Epub 2018 Dec 6.
PubMed 30522138Kelly JC, Groarke PJ, Butler JS, Poynton AR, O'Byrne JM. The natural history and clinical syndromes of degenerative cervical spondylosis. Adv Orthop. 2012;2012:393642. doi: 10.1155/2012/393642. Epub 2011 Nov 28.
PubMed 22162812Grasso G, Salli M, Torregrossa F. Does Hybrid Surgery Improve Quality of Life in Multilevel Cervical Degenerative Disk Disease? Five-Year Follow-up Study. World Neurosurg. 2020 Aug;140:527-533. doi: 10.1016/j.wneu.2020.03.097.
PubMed 32797985Apaydin AS, Gunes M. Relationships between stenosis severity, functional limitation, pain, and quality of life in patients with cervical spondylotic radiculopathy. Turk J Med Sci. 2024 Jun 6;54(4):727-734. doi: 10.55730/1300-0144.5842. eCollection 2024.
PubMed 39295627
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Limitation, Pain, Disability and Quality of Life in Patients With Cervical Spondylotic Radiculopathy
- ClinicalTrials.gov ID
- NCT06001359
- Acronym / sponsor ID
- radiculopathy
- Conditions
- Radiculopathy, Elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 21 Aug 2023 (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.
Radiculopathy is a neurological condition in which transmission along a spinal nerve and its roots is limited or inhibited. It is most caused by spondylotic changes such as cervical disc herniation leading to nerve root compression, inflammatory changes, and the formation of bony prominences in this region [1]. Pain is the initial symptom and cervical radiculopathy should be suspected when pain radiates from the neck to the shoulder and arm, accompanied by sensory complaints and motor weakness. It is most commonly caused by spondylotic changes, such as cervical disc herniation and bony prominences in this area, leading to nerve root compression and inflammatory changes. Stenotic changes in the spine, which are often observed with aging, can cause nerve damage and compression in individuals, causing radicular pain. However, there is insufficient study in which the relationship between pain caused by cervical spondylotic radiculopathy caused by stenosis and functional disability, disability and quality of life due to radiculopathy in patients is insufficient. In addition, the lack of a comprehensive outcome scale that evaluates the functional limitation caused by radicular pain has also led to a deficiency in the evaluation of functional limitation. In this context, CRES is a newly developed scale used to evaluate functional limitation associated with radicular pain. In this context, in this study, it was aimed to examine the relationship between pain, functional disability, disability and quality of life in patients with cervical spondylotic radiculopathy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 64 patients with spondylotic radiculopathy will be included.
Key inclusion criteria (4 listed)
- over 18 years of age
- with lateral-foraminal spinal stenosis in the cervical region
- with or without neck pain consistent with the diagnosis obtained from magnetic resonance imaging
- with unilateral root symptoms such as pain, numbness, weakness in the affected limb, and diagnosis based on MRI and computerized tomography
Key exclusion criteria (4 listed)
- signs of increased ventral pressure, such as ventral osteophytes, disc calcification, and ligament hypertrophy
- severe neurological deficits, pregnant women, spinal malignancies,
- those who had undergone cervical surgery in the last 12 months
- and those who could not cooperate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Neck/Arm Pain
Time frame: baseline
A numeric rating scale will be used to evaluate neck and arm pain severity.
Funcitonal disability
Time frame: baseline
The Cervical Radiculopathy Impact Scale (CRIS) will used to determine the functional limitation.
Disability
Time frame: baseline
Neck Disability Index (NDI) will used to evaluate the effect of neck pain on activities of daily living
life quality
Time frame: baseline
The EuroQol Five-Dimensions - 3-Level (EQ-5D-3L) General Quality of Life Scale will used to evaluate the quality of life of individuals
Severity of stenosis
Time frame: baseline
The severity of stenosis will be evaluated with MRI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Background: PubMed 22531897Thoomes EJ, Scholten-Peeters GG, de Boer AJ, Olsthoorn RA, Verkerk K, Lin C, Verhagen AP. Lack of uniform diagnostic criteria for cervical radiculopathy in conservative intervention studies: a systematic review. Eur Spine J. 2012 Aug;21(8):1459-70. doi: 10.1007/s00586-012-2297-9. Epub 2012 Apr 25.
- Background: PubMed 30522138Patel EA, Perloff MD. Radicular Pain Syndromes: Cervical, Lumbar, and Spinal Stenosis. Semin Neurol. 2018 Dec;38(6):634-639. doi: 10.1055/s-0038-1673680. Epub 2018 Dec 6.
- Background: PubMed 22162812Kelly JC, Groarke PJ, Butler JS, Poynton AR, O'Byrne JM. The natural history and clinical syndromes of degenerative cervical spondylosis. Adv Orthop. 2012;2012:393642. doi: 10.1155/2012/393642. Epub 2011 Nov 28.
- Results publication: PubMed 32797985Grasso G, Salli M, Torregrossa F. Does Hybrid Surgery Improve Quality of Life in Multilevel Cervical Degenerative Disk Disease? Five-Year Follow-up Study. World Neurosurg. 2020 Aug;140:527-533. doi: 10.1016/j.wneu.2020.03.097.
- Derived from this study: PubMed 39295627Apaydin AS, Gunes M. Relationships between stenosis severity, functional limitation, pain, and quality of life in patients with cervical spondylotic radiculopathy. Turk J Med Sci. 2024 Jun 6;54(4):727-734. doi: 10.55730/1300-0144.5842. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Aydın Sinan Apaydın, PhD study director
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiculopathy and Elderly, run by Karabuk University 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 4 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 22 Mar 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?
Contact Aydın Sinan Aydın Sinan, +905065897613 (+905065897613, dr.sinanapaydin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck/Arm Pain (time frame: baseline). The study lists 5 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 NCT06001359, 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 22 Mar 2024.