Upper Extremity Dysfunction in Patients With Cervical Radiculopathy (CerRad-UE)

April 3, 2025 updated by: Tuba Eren, University of Beykent

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • None Selected
      • Istanbul, None Selected, Turkey, 34100
        • Istanbul Beykent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Systemic disorders
  • Neurological disorders (excluding CR)
  • Previous spinal surgery
  • Acute trauma
  • Fracture
  • Malignancy
  • Osteoporosis
  • Rheumatic disease
  • Ongoing pharmacological treatment for chronic neck pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other: Observational Assessment Only
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.
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).
Other: Observational Assessment Only
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.
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).
Other: Observational Assessment Only
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.
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).
Other: Observational Assessment Only
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Single assessment at study enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Light Touch Sensation
Time Frame: Single assessment at study enrollment
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.
Single assessment at study enrollment
Vibration Sense
Time Frame: Single assessment at study enrollment
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.
Single assessment at study enrollment
Upper Extremity Function
Time Frame: Single assessment at study enrollment
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.
Single assessment at study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Beykent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO 21/906

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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