Cervical RadiculopathyCerRad-UENCT06923085
Upper Extremity Dysfunction in Patients With Cervical Radiculopathy
An observational study of Cervical Radiculopathy, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
This study will examine how cervical radiculopathy (a pinched nerve in the neck) affects function in both arms, not just the symptomatic side. The investigators will evaluate 42 patients with different cervical nerve root involvement (C4-5, C5-6, or C6-7) and compare them to 16 control subjects with non-specific neck… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Observational Assessment Only
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Sep 2021to 22 Apr 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective study will include patients with cervical radiculopathy (CR) and a control group with mechanical neck pain. Participants aged 18 to 65 years will be recruited from X Hospital. CR diagnosis will be confirmed by medical history, physical examination, and MRI findings. Patients will be categorized into three subgroups based on the affected cervical level: C4-5 (C5), C5-6 (C6), and C6-7 (C7). Exclusion criteria will include systemic or neurological disorders (excluding CR), previous spinal surgery, acute trauma, fracture, malignancy, osteoporosis, rheumatic disease, or ongoing treatment for chronic neck pain. Only patients with neck pain for at least three months will be eligible. MRI findings, dermatome mapping, and physical examination will be used to determine the primary affected level in cases of overlapping symptoms.
Who may be able to join
- Age 18-65 years
- Clinical diagnosis of unilateral cervical radiculopathy at C4-5, C5-6, or C6-7 level
- Diagnosis confirmed by clinical examination and MRI
- Symptoms present for at least 4 weeks prior to enrollment
- Ability to understand and follow study instructions
- Ability to provide informed consent for participation
- For control group: non-specific neck pain without radiculopathy
- Ability to complete required assessments
Who cannot join
- Systemic disorders
- Neurological disorders (excluding CR)
- Previous spinal surgery
- Acute trauma
- Fracture
- Malignancy
Show all 9Show fewer
- Osteoporosis
- Rheumatic disease
- Ongoing pharmacological treatment for chronic neck pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Beykent University
Istanbul, None Selected, 34100
About this study
Official title: Bilateral Sensorimotor Dysfunction in the Upper Extremities in Unilateral Cervical Radiculopathies: A Level-Specific Approach
This study will examine how cervical radiculopathy (a pinched nerve in the neck) affects function in both arms, not just the symptomatic side. The investigators will evaluate 42 patients with different cervical nerve root involvement (C4-5, C5-6, or C6-7) and compare them to 16 control subjects with non-specific neck pain. The assessments will measure muscle strength, sensory function, hand performance, pain levels, and psychological factors. These evaluations may contribute to the development of rehabilitation programs for cervical radiculopathy.
- Conditions
- Cervical Radiculopathy
- Being tested
- Observational Assessment Only
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Assessment OnlyOther
This is an observational study examining bilateral sensorimotor function in patients with cervical radiculopathy. No interventional procedures were applied. Participants underwent comprehensive assessments including pain evaluation (VAS), neck disability (NDI), upper extremity functionality (DASH), muscle strength measurements, sensory function testing, hand performance evaluation, kinesiophobia (TAMPA), and emotional status assessment (Beck Inventory). The study compared findings between different cervical radiculopathy groups and a control group with non-specific neck pain.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: C4-5 Radiculopathy Group | Patients with confirmed C4-5 cervical radiculopathy. Assessments included pain (VAS), neck disability (NDI), upper extremity functionality (DASH), muscle strength measurements, sensory function, hand performance, kinesiophobia (TAMPA) and emotional status (Beck Inventory). Receives: Other: Observational Assessment Only | |
| Group 2: C5-6 Radiculopathy Group | Patients with confirmed C5-6 cervical radiculopathy. Assessments included pain (VAS), neck disability (NDI), upper extremity functionality (DASH), muscle strength measurements, sensory function, hand performance, kinesiophobia (TAMPA) and emotional status (Beck Inventory). Receives: Other: Observational Assessment Only | |
| Group 3: C6-7 Radiculopathy Group | Patients with confirmed C6-7 cervical radiculopathy. Assessments included pain (VAS), neck disability (NDI), upper extremity functionality (DASH), muscle strength measurements, sensory function, hand performance, kinesiophobia (TAMPA) and emotional status (Beck Inventory). Receives: Other: Observational Assessment Only | |
| Control Group | Control subjects with non-specific neck pain without radiculopathy. Assessments included pain (VAS), neck disability (NDI), upper extremity functionality (DASH), muscle strength measurements, sensory function, hand performance, kinesiophobia (TAMPA) and emotional status (Beck Inventory). Receives: Other: Observational Assessment Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Upper extremity muscle strength will be measured using a calibrated digital dynamometer. Measurements will be performed for shoulder flexors, extensors, and abductors, elbow flexors and extensors, wrist flexors and extensors, and forearm supination and pronation. Three consecutive measurements will be taken during maximal isometric contraction for each muscle group while the patient is seated in a standardized position, and the highest value will be recorded in Newtons (N). A 30-second rest period will be provided between measurements. Testing will be conducted bilaterally, with the unaffected side tested first.
Measured: Single assessment at study enrollment
Secondary outcomes (3)
Light Touch Sensation
Light touch sensation will be assessed bilaterally using the Semmes-Weinstein monofilament test kit (North Coast Medical Inc., Gilroy, CA, USA). Testing will follow standardized protocols, starting with the 2.83 filament applied to three specific locations on each hand: thumb, index finger, and little finger. Each monofilament will be applied at a 90-degree angle with sufficient pressure to bend it for 1-1.5 seconds, and repeated three times at each location. Participants will respond "yes" when they feel the stimulus. A threshold will be considered achieved when the patient correctly identifies at least seven out of ten applications. Results will be classified as normal (1.65-2.83), diminished light touch (3.22-3.61), diminished protective sensation (3.84-4.31), loss of protective sensation (4.56-6.65), and unmeasurable sensation (above 6.65). Comparison between affected and unaffected sides will be documented.
Measured: Single assessment at study enrollment
Vibration Sense
Vibration sense will be evaluated using a 128 Hz tuning fork applied to the radial and ulnar styloid processes. Participants will be seated with forearms supported and wrists in neutral position. The tuning fork will be struck and applied to each styloid process, with participants indicating when vibration starts and stops. Three measurements will be taken at each site with 30-second intervals between tests. The duration of perceived vibration will be recorded and averaged. Results will be classified as normal, diminished, or absent based on age-normalized values. Comparison between affected and unaffected sides will be documented.
Measured: Single assessment at study enrollment
Upper Extremity Function
Upper extremity functional level will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, a standardized 30-item self-report measure validated for upper extremity symptoms and activity limitations. Each item is scored from 1 (no disability) to 5 (most severe disability), with total scores converted to a 0-100 scale. Higher scores indicate greater disability. The questionnaire will be completed by participants at the study enrollment visit.RetryClaude can make mistakes. Please double-check responses.
Measured: Single assessment at study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start22 Sep 2021
- Primary completion22 Apr 2023
- Study completion22 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Eren, University of Beykent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923085
- Sponsor's protocol ID
- GO 21/906
- Acronym
- CerRad-UE
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Sensorimotor Dysfunction in the Upper Extremities in Unilateral Cervical Radiculopathies: A Level-Specific Approach
- ClinicalTrials.gov ID
- NCT06923085
- Acronym / sponsor ID
- CerRad-UE / GO 21/906
- Conditions
- Cervical Radiculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 22 Apr 2023 (actual)
- Study completion
- 22 Apr 2023 (actual)
- First posted
- 11 Apr 2025 (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.
This study will examine how cervical radiculopathy (a pinched nerve in the neck) affects function in both arms, not just the symptomatic side. The investigators will evaluate 42 patients with different cervical nerve root involvement (C4-5, C5-6, or C6-7) and compare them to 16 control subjects with non-specific neck pain. The assessments will measure muscle strength, sensory function, hand performance, pain levels, and psychological factors. These evaluations may contribute to the development of rehabilitation programs for cervical radiculopathy.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: C4-5 Radiculopathy Group | – | Other: Observational Assessment OnlyPatients with confirmed C4-5 cervical radiculopathy. Assessments included pain (VAS), neck disability (NDI), upper extremity functionality (DASH), muscle strength measurements, sensory function, hand performance, kinesiophobia (TAMPA) and emotional status (Beck Inventory). |
| Group 2: C5-6 Radiculopathy Group | – | Other: Observational Assessment OnlyPatients with confirmed C5-6 cervical radiculopathy. Assessments included pain (VAS), neck disability (NDI), upper extremity functionality (DASH), muscle strength measurements, sensory function, hand performance, kinesiophobia (TAMPA) and emotional status (Beck Inventory). |
| Group 3: C6-7 Radiculopathy Group | – | Other: Observational Assessment OnlyPatients with confirmed C6-7 cervical radiculopathy. Assessments included pain (VAS), neck disability (NDI), upper extremity functionality (DASH), muscle strength measurements, sensory function, hand performance, kinesiophobia (TAMPA) and emotional status (Beck Inventory). |
| Control Group | – | Other: Observational Assessment OnlyControl subjects with non-specific neck pain without radiculopathy. Assessments included pain (VAS), neck disability (NDI), upper extremity functionality (DASH), muscle strength measurements, sensory function, hand performance, kinesiophobia (TAMPA) and emotional status (Beck Inventory). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective study will include patients with cervical radiculopathy (CR) and a control group with mechanical neck pain. Participants aged 18 to 65 years will be recruited from X Hospital. CR diagnosis will be confirmed by medical history, physical examination, and MRI findings. Patients will be categorized into three subgroups based on the affected cervical level: C4-5 (C5), C5-6 (C6), and C6-7 (C7). Exclusion criteria will include systemic or neurological disorders (excluding CR), previous spinal surgery, acute trauma, fracture, malignancy, osteoporosis, rheumatic disease, or ongoing treatment for chronic neck pain. Only patients with neck pain for at least three months will be eligible. MRI findings, dermatome mapping, and physical examination will be used to determine the primary affected level in cases of overlapping symptoms.
Key inclusion criteria (8 listed)
- Age 18-65 years
- Clinical diagnosis of unilateral cervical radiculopathy at C4-5, C5-6, or C6-7 level
- Diagnosis confirmed by clinical examination and MRI
- Symptoms present for at least 4 weeks prior to enrollment
- Ability to understand and follow study instructions
Key exclusion criteria (9 listed)
- Systemic disorders
- Neurological disorders (excluding CR)
- Previous spinal surgery
- Acute trauma
- Fracture
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 |
|---|---|---|
| Observational Assessment OnlyThis is an observational study examining bilateral sensorimotor function in patients with cervical radiculopathy. No interventional procedures were applied. Participants underwent comprehensive assessments including pain evaluation (VAS), neck disability (NDI), upper extremity functionality (DASH), muscle strength measurements, sensory function testing, hand performance evaluation, kinesiophobia (TAMPA), and emotional status assessment (Beck Inventory). The study compared findings between different cervical radiculopathy groups and a control group with non-specific neck pain. | Other | Control Group, Group 1: C4-5 Radiculopathy Group, Group 2: C5-6 Radiculopathy Group, Group 3: C6-7 Radiculopathy Group |
Primary outcome
Muscle Strength
Time frame: Single assessment at study enrollment
Upper extremity muscle strength will be measured using a calibrated digital dynamometer. Measurements will be performed for shoulder flexors, extensors, and abductors, elbow flexors and extensors, wrist flexors and extensors, and forearm supination and pronation. Three consecutive measurements will be taken during maximal isometric contraction for each muscle group while the patient is seated in a standardized position, and the highest value will be recorded in Newtons (N). A 30-second rest period will be provided between measurements. Testing will be conducted bilaterally, with the unaffected side tested first.
3 secondary outcomes
Light Touch Sensation
Time frame: Single assessment at study enrollment
Vibration Sense
Time frame: Single assessment at study enrollment
Upper Extremity Function
Time frame: Single assessment at study enrollment
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 11 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cervical Radiculopathy, run by University of Beykent 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 8 inclusion and 9 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 11 Apr 2025. 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?
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?
Muscle Strength (time frame: Single assessment at study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2025; AzTrials last refreshed its copy on 27 Oct 2026.