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NCT Number: NCT06381011

Local Vibration in Cervical Radiculopathy

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,
  • 5. Presence of local infection at the application site,
  • 6. Upper extremity nerve entrapment syndrome (such as carpal tunnel or cubital tunnel syndrome),
  • 7. Diagnosis of systemic inflammatory arthritis (such as rheumatoid arthritis, etc.),
  • 8. Having engaged in strenuous exercise in the last 24 hours,
  • 9. Poor or noncompliance to the treatment program

Treatment and study plan

Local Vibration

Other

The patients in the study group will receive local vibration application including different frequency values on the neck and back regions for five consecutive days.

Primary outcomes

  1. Neck Pain

    Time frame: 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.'

  2. Upper Limb Pain

    Time frame: 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.'

  3. Paresthesia

    Time frame: 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.'

Secondary outcomes

  1. Cervical Range of Motion

    Time frame: 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.

  2. The Change in the Pressure Pain Threshold of the Upper Trapezius

    Time frame: 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.

  3. The Change in the Viscoelastic Properties of the Upper Trapezius

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erhan Dincer, M.Sc.

CONTACT

[email protected]

5442543857 ext. +90

Ömer Dursun, Asst. Prof.

CONTACT

[email protected]

5426088687 ext. +90

Sponsors and collaborators

Lead sponsor

Bitlis Eren University

Other

Registry information

Official study title

Can Local Vibration be Used to Alleviate Symptoms of Cervical Radiculopathy?

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2024
Registry last updated
Aug 12, 2024

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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