Local Vibration in Cervical Radiculopathy

NCT06381011 | Recruiting

• 1 other identifier: BEUFTR-4
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Radiculopathy

Keywords

neck pain; paresthesia

Outcome Measures

Primary Outcomes (3)

• Neck Pain

  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

  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

  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 Outcomes (3)

• Cervical Range of Motion

  Change from baseline neck pain immediately and five days after the intervention

• The Change in the Pressure Pain Threshold of the Upper Trapezius

  Change from baseline neck pain immediately and five days after the intervention

• The Change in the Viscoelastic Properties of the Upper Trapezius

  Change from baseline neck pain immediately and five days after the intervention

Study Arms (2)

Sham Local Vibration Group

SHAM COMPARATOR

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

Local Vibration Intervention Group

EXPERIMENTAL

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

Interventions

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.

Local Vibration Intervention Group; Sham Local Vibration Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (1)

Bitlis Tatvan State Hospital

Bitlis, Tatvan, 13200, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Alshami AM, Bamhair DA. Effect of manual therapy with exercise in patients with chronic cervical radiculopathy: a randomized clinical trial. Trials. 2021 Oct 18;22(1):716. doi: 10.1186/s13063-021-05690-y.

  PMID: 34663421 BACKGROUND

• Abbed KM, Coumans JV. Cervical radiculopathy: pathophysiology, presentation, and clinical evaluation. Neurosurgery. 2007 Jan;60(1 Supp1 1):S28-34. doi: 10.1227/01.NEU.0000249223.51871.C2.

  PMID: 17204882 BACKGROUND

MeSH Terms

Conditions

Radiculopathy; Neck Pain; Paresthesia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders

Study Officials

• Ömer Dursun, Asst. Prof.

  Bitlis Eren University

  PRINCIPAL INVESTIGATOR

• Gökmen Reyhanlı, M.D.

  Bitlis Tatvan State Hospital

  PRINCIPAL INVESTIGATOR

• Erhan Dincer, M.Sc.

  Bitlis Eren University

  PRINCIPAL INVESTIGATOR

• Abdurrahman Tanhan, Ph.D.

  Bitlis Eren University

  PRINCIPAL INVESTIGATOR

• Etem Öztürk

  Bitlis Tatvan State Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ömer Dursun, Asst. Prof.

CONTACT

5426088687; fztomrdrsn@gmail.com

Erhan Dincer, M.Sc.

CONTACT

5442543857; fzterhan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The evaluator and the researcher administering the local vibration application will be different. Patients will be blinded to their group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 24, 2024
• Study Start: August 5, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)