Upper Extremity Dysfunction in Patients With Cervical Radiculopathy

Completed

• Conditions: Cervical Radiculopathy

• Registration Number: NCT06923085
• Lead Sponsor: University of Beykent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-22
• Primary Completion: 2023-04-22
• Study Completion: 2023-04-22
• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Muscle Strength	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 Outcome Measures

Name	Time	Method
Light Touch Sensation	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.
Vibration Sense	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.
Upper Extremity Function	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.

Trial Locations

Locations (1)

İstanbul Beykent University; 🇹🇷 Istanbul, None Selected, Turkey