Local Vibration in Cervical Radiculopathy

August 8, 2024 updated by: Omer Dursun, Bitlis Eren University

Can Local Vibration be Used to Alleviate Symptoms of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Tatvan
      • Bitlis, Tatvan, Turkey, 13200
        • Recruiting
        • Bitlis Tatvan State Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Local Vibration Group
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.
Other: Local Vibration
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.
Experimental: Local Vibration Intervention Group
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.
Other: Local Vibration
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.'
Change from baseline neck pain immediately and five days after the intervention
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.'
Change from baseline neck pain immediately and five days after the intervention
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.'
Change from baseline neck pain immediately and five days after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline neck pain immediately and five days after the intervention
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.
Change from baseline neck pain immediately and five days after the intervention
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.
Change from baseline neck pain immediately and five days after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bitlis Eren University

Investigators

  • Principal Investigator: ömer dursun, Asst. Prof., Bitlis Eren University
  • Principal Investigator: Erhan Dincer, M.Sc., Bitlis Eren University
  • Principal Investigator: Abdurrahman Tanhan, Ph.D., Bitlis Eren University
  • Principal Investigator: Gökmen Reyhanlı, M.D., Bitlis Tatvan State Hospital
  • Principal Investigator: Etem Öztürk, Bitlis Tatvan State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEUFTR-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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