NCT06923085

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
Last Updated

April 11, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

March 11, 2025

Last Update Submit

April 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Single assessment at study enrollment

Secondary Outcomes (3)

  • Light Touch Sensation

    Single assessment at study enrollment

  • Vibration Sense

    Single assessment at study enrollment

  • Upper Extremity Function

    Single assessment at study enrollment

Study Arms (4)

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

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

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

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

Interventions

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 GroupGroup 1: C4-5 Radiculopathy GroupGroup 2: C5-6 Radiculopathy GroupGroup 3: C6-7 Radiculopathy Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Beykent University

Istanbul, None Selected, 34100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 11, 2025

First Posted

April 11, 2025

Study Start

September 22, 2021

Primary Completion

April 22, 2023

Study Completion

April 22, 2023

Last Updated

April 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations