Local Vibration in Cervical Radiculopathy
ConditionCervical Radiculopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBitlis Eren University
About this trial
The aim of this study is to evaluate the effect of local vibration application on the upper extremity pain, paresthesia, neck pain, and limitations in cervical joint range of motion experienced by patients with cervical radiculopathy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Between the ages of 18 and 70,
2. Nerve root compression according to the magnetic resonance imaging,
3. Unilateral or bilateral neck pain rated 3 or higher on the Numeric Pain Rating Scale, or neck pain with paresthesia or upper extremity pain rated 3 or higher on the Numeric Pain Rating Scale.
Disqualifiers
1. History of previous cervical or thoracic spinal surgery,
2. Symptoms or signs of upper motor neuron disorder,
3. Body mass index (BMI) higher than 35 kg/m2,
4. Having received spinal injection in the last two weeks,
Trial design
Design model
Parallel
Treatments tested in this trial
Local Vibration
Other interventionThe patients in the study group will receive local vibration application including different frequency values on the neck and back regions for five consecutive days.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Sham Local Vibration GroupSham comparator 1 intervention
Group B: Local Vibration Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Neck Pain
The effect of local vibration intervention on patients' neck pain will be evaluated using the Patients' Global Impression of Improvement Scale. In this scale, patients will be asked to mark their perceived change in pain using the following options: 'very much better,' 'much better,' 'a little better,' 'no change,' 'a little worse,' 'much worse,' and 'very much worse.'
Time frame
Change from baseline neck pain immediately and five days after the intervention2
Upper Limb Pain
The effect of local vibration intervention on patients' upper limb pain will be evaluated using the Patients' Global Impression of Improvement Scale. In this scale, patients will be asked to mark their perceived change in pain using the following options: 'very much better,' 'much better,' 'a little better,' 'no change,' 'a little worse,' 'much worse,' and 'very much worse.'
Time frame
Change from baseline neck pain immediately and five days after the intervention3
Paresthesia
The effect of local vibration intervention on patients' paresthesia will be evaluated using the Patients' Global Impression of Improvement Scale. In this scale, patients will be asked to mark their perceived change in paresthesia using the following options: 'very much better,' 'much better,' 'a little better,' 'no change,' 'a little worse,' 'much worse,' and 'very much worse.'
Time frame
Change from baseline neck pain immediately and five days after the interventionSecondary outcomes
1
Cervical Range of Motion
The immediate and short-term effect of local vibration intervention on cervical range of motion will be measured using a 10-inch standard manual goniometer. To measure cervical flexion and extension range of motion, the pivot point of the goniometer will be placed at the external auditory meatus. The fixed arm of the goniometer will be held vertically, and the moving arm will follow along the base of the nostrils. For measuring cervical rotation range of motion, measurements will be taken from behind the participants. The pivot point of the goniometer will be placed at the vertex, while the fixed arm will be kept parallel to the acromion, and the moving arm will follow along with their nose. Lateral flexion range of motion will be taken in front of the participants. The pivot point of the goniometer will be placed over the sternal notch, with its fixed arm parallel to the acromion, and its moving arm will follow along the tip of the participants' nose.
Time frame
Change from baseline neck pain immediately and five days after the intervention2
The Change in the Pressure Pain Threshold of the Upper Trapezius
The potential impact of local vibration intervention on patients' pain thresholds will be evaluated using an analog algometer. Pain threshold measurements will be taken at the upper trapezius muscle. The algometer will be positioned perpendicular to the measurement areas. Three measurements will be taken for each region, with a half-minute interval between measurements. The average of the three measurements will be calculated and recorded. A change of 20-25% in the algometric measurement values will be considered significant.
Time frame
Change from baseline neck pain immediately and five days after the intervention3
The Change in the Viscoelastic Properties of the Upper Trapezius
The effect of local vibration intervention on the viscoelastic properties of patients' upper trapezius will be measured using the myotonometer (MyotonPRO). The upper trapezius myometric measurement will be taken with the patient seated on a chair with hands placed over knees, and measured from the midpoint between the C7 spinous process and the acromion.
Time frame
Change from baseline neck pain immediately and five days after the interventionSponsors and contacts
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Source ClinicalTrials.gov