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Completed

NCT Number: NCT06923085

Upper Extremity Dysfunction in Patients With Cervical Radiculopathy

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

İstanbul Beykent University

Istanbul, None Selected, 34100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational Assessment Only

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Beykent

Other

Registry information

Official study title

Bilateral Sensorimotor Dysfunction in the Upper Extremities in Unilateral Cervical Radiculopathies: A Level-Specific Approach

Acronym: CerRad-UE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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