Clinical trial NCT06381011: Local Vibration in Cervical Radiculopathy
Official title: Can Local Vibration be Used to Alleviate Symptoms of Cervical Radiculopathy?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: neck pain
paresthesia
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Neck Pain
timeFrame: Change from baseline neck pain immediately and five days after the intervention
measure: Upper Limb Pain
timeFrame: Change from baseline neck pain immediately and five days after the intervention
measure: Paresthesia
timeFrame: Change from baseline neck pain immediately and five days after the intervention
Secondary outcomes:
measure: Cervical Range of Motion
timeFrame: Change from baseline neck pain immediately and five days after the intervention
measure: The Change in the Pressure Pain Threshold of the Upper Trapezius
timeFrame: Change from baseline neck pain immediately and five days after the intervention
measure: The Change in the Viscoelastic Properties of the Upper Trapezius
timeFrame: Change from baseline neck pain immediately and five days after the intervention
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Tatvan State Hospital
state: Tatvan
Study officials:
affiliation: Bitlis Eren University
name: Ömer Dursun, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bitlis Tatvan State Hospital
name: Gökmen Reyhanlı, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bitlis Eren University
name: Erhan Dincer, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bitlis Eren University
name: Abdurrahman Tanhan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bitlis Tatvan State Hospital
name: Etem Öztürk
role: PRINCIPAL_INVESTIGATOR
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