Local Vibration in Cervical Radiculopathy

Official title

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

Overview

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

Interventions

• 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.

Primary outcome measures

• Neck Pain [Time frame: 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]
• Paresthesia [Time frame: Change from baseline neck pain immediately and five days after the intervention]

Secondary outcome measures (3)

• Cervical Range of Motion [Time frame: 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 Change in the Viscoelastic Properties of the Upper Trapezius [Time frame: Change from baseline neck pain immediately and five days after the intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Bitlis Tatvan State Hospital — Bitlis

Publications

• Wainner RS, Fritz JM, Irrgang JJ, Boninger ML, Delitto A, Allison S. Reliability and diagnostic accuracy of the clinical examination and patient self-report measures for cervical radiculopathy. Spine (Phila Pa 1976). 2003 Jan 1;28(1):52-62. doi: 10.1097/00007632-200301010-00014. PMID 12544957
• Young IA, Michener LA, Cleland JA, Aguilera AJ, Snyder AR. Manual therapy, exercise, and traction for patients with cervical radiculopathy: a randomized clinical trial. Phys Ther. 2009 Jul;89(7):632-42. doi: 10.2522/ptj.20080283. Epub 2009 May 21. PMID 19465371
• Thoomes EJ, van Geest S, van der Windt DA, Falla D, Verhagen AP, Koes BW, Thoomes-de Graaf M, Kuijper B, Scholten-Peeters WGM, Vleggeert-Lankamp CL. Value of physical tests in diagnosing cervical radiculopathy: a systematic review. Spine J. 2018 Jan;18(1):179-189. doi: 10.1016/j.spinee.2017.08.241. Epub 2017 Aug 31. PMID 28838857
• Wong JJ, Cote P, Quesnele JJ, Stern PJ, Mior SA. The course and prognostic factors of symptomatic cervical disc herniation with radiculopathy: a systematic review of the literature. Spine J. 2014 Aug 1;14(8):1781-9. doi: 10.1016/j.spinee.2014.02.032. Epub 2014 Mar 12. PMID 24614255
• Young IA, Pozzi F, Dunning J, Linkonis R, Michener LA. Immediate and Short-term Effects of Thoracic Spine Manipulation in Patients With Cervical Radiculopathy: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2019 May;49(5):299-309. doi: 10.2519/jospt.2019.8150. Epub 2019 Apr 25. PMID 31021691
• Ayub A, Osama M, Ahmad S. Effects of active versus passive upper extremity neural mobilization combined with mechanical traction and joint mobilization in females with cervical radiculopathy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(5):725-730. doi: 10.3233/BMR-170887. PMID 30664500
• Rubinstein SM, Pool JJ, van Tulder MW, Riphagen II, de Vet HC. A systematic review of the diagnostic accuracy of provocative tests of the neck for diagnosing cervical radiculopathy. Eur Spine J. 2007 Mar;16(3):307-19. doi: 10.1007/s00586-006-0225-6. Epub 2006 Sep 30. PMID 17013656
• Taso M, Sommernes JH, Kolstad F, Sundseth J, Bjorland S, Pripp AH, Zwart JA, Brox JI. A randomised controlled trial comparing the effectiveness of surgical and nonsurgical treatment for cervical radiculopathy. BMC Musculoskelet Disord. 2020 Mar 16;21(1):171. doi: 10.1186/s12891-020-3188-6. PMID 32178655

Identifiers

NCT: NCT06381011 · BEUFTR-4

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗