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Local Vibration in Cervical Radiculopathy

B

Bitlis Eren University

Status

Enrolling

Conditions

Cervical Radiculopathy

Treatments

Other: Local Vibration

Study type

Interventional

Funder types

Other

Identifiers

NCT06381011
BEUFTR-4

Details and patient eligibility

About

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.

Full 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

Enrollment

34 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

    1. Between the ages of 18 and 70,
    1. Nerve root compression according to the magnetic resonance imaging,
    1. 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.

Exclusion criteria

    1. History of previous cervical or thoracic spinal surgery,
    1. Symptoms or signs of upper motor neuron disorder,
    1. Body mass index (BMI) higher than 35 kg/m2,
    1. Having received spinal injection in the last two weeks,
    1. Presence of local infection at the application site,
    1. Upper extremity nerve entrapment syndrome (such as carpal tunnel or cubital tunnel syndrome),
    1. Diagnosis of systemic inflammatory arthritis (such as rheumatoid arthritis, etc.),
    1. Having engaged in strenuous exercise in the last 24 hours,
    1. Poor or noncompliance to the treatment program

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

34 participants in 2 patient groups

Sham Local Vibration Group
Sham Comparator group
Description:
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.
Treatment:
Other: Local Vibration
Local Vibration Intervention Group
Experimental group
Description:
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.
Treatment:
Other: Local Vibration

Trial contacts and locations

1

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Central trial contact

Ömer Dursun, Asst. Prof.; Erhan Dincer, M.Sc.

Data sourced from clinicaltrials.gov

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