Local Vibration in Cervical Radiculopathy
- Conditions
- Cervical Radiculopathy
- Interventions
- Other: Local Vibration
- Registration Number
- NCT06381011
- Lead Sponsor
- Bitlis Eren University
- Brief Summary
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.
- Detailed Description
At least 34 patients diagnosed with cervical radiculopathy who meet the inclusion and exclusion criteria will be included in the study. Subsequently, the patients will be randomly divided into two groups. Patients in the first group will receive placebo local vibration application in addition to conventional treatment, while patients in the second group will receive local vibration application in addition to conventional treatment
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 34
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- Between the ages of 18 and 70,
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- Nerve root compression according to the magnetic resonance imaging,
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- 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.
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- History of previous cervical or thoracic spinal surgery,
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- Symptoms or signs of upper motor neuron disorder,
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- Body mass index (BMI) higher than 35 kg/m2,
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- Having received spinal injection in the last two weeks,
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- Presence of local infection at the application site,
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- Upper extremity nerve entrapment syndrome (such as carpal tunnel or cubital tunnel syndrome),
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- Diagnosis of systemic inflammatory arthritis (such as rheumatoid arthritis, etc.),
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- Having engaged in strenuous exercise in the last 24 hours,
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- Poor or noncompliance to the treatment program
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Local Vibration Intervention Group Local Vibration In addition to conventional treatment program the patients in this group will receive bilateral local vibration application on the cervicothoracic region, utilizing two different frequency values, 50 Hz and 100 Hz. Initially, a flat attachment will be placed on the device, and application will be performed on the neck and back regions for 5 minutes at a frequency of 50 Hz. Then, the other attachment of the device will be used, the frequency value will be increased to 100 Hz, and application will be performed on a total of 5 sensitive points specified by the manufacturer in the neck and back regions, with one minute per point for a total of 5 minutes. Local vibration will be applied to each side for ten minutes, totaling 20 minutes, and this will be conducted for five consecutive days. To determine which side to start the application from, a coin toss will be performed. Sham Local Vibration Group Local Vibration In addition to conventional treatment program the placebo local vibration application will be applied bilaterally to the cervicothoracic region of the patients in the placebo group. For the application, the patient will be placed in an upright sitting position, and the local vibration device will be moved without touching the patient's skin while it is operational.
- Primary Outcome Measures
Name Time Method Paresthesia Change from baseline neck pain immediately and five days after the intervention 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.'
Neck Pain Change from baseline neck pain immediately and five days after the intervention 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.'
Upper Limb Pain Change from baseline neck pain immediately and five days after the intervention 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.'
- Secondary Outcome Measures
Name Time Method Cervical Range of Motion Change from baseline neck pain immediately and five days after the intervention 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.
The Change in the Pressure Pain Threshold of the Upper Trapezius Change from baseline neck pain immediately and five days after the intervention 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.
The Change in the Viscoelastic Properties of the Upper Trapezius Change from baseline neck pain immediately and five days after the intervention 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.
Trial Locations
- Locations (1)
Bitlis Tatvan State Hospital
🇹🇷Bitlis, Tatvan, Turkey