Local Vibration in Cervical Radiculopathy

NCT ID: NCT06381011

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-05

Study Completion Date

2024-12-01

Brief Summary

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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

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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

Conditions

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Cervical Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
The evaluator and the researcher administering the local vibration application will be different. Patients will be blinded to their group assignment.

Study Groups

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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.

Group Type SHAM_COMPARATOR

Local Vibration

Intervention Type 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

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.

Group Type EXPERIMENTAL

Local Vibration

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bitlis Eren University

OTHER

Sponsor Role lead

Responsible Party

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Omer Dursun

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ömer Dursun, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Bitlis Eren University

Gökmen Reyhanlı, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bitlis Tatvan State Hospital

Erhan Dincer, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Bitlis Eren University

Abdurrahman Tanhan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Bitlis Eren University

Etem Öztürk

Role: PRINCIPAL_INVESTIGATOR

Bitlis Tatvan State Hospital

Locations

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Bitlis Tatvan State Hospital

Bitlis, Tatvan, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ömer Dursun, Asst. Prof.

Role: CONTACT

5426088687 ext. +90

Erhan Dincer, M.Sc.

Role: CONTACT

5442543857 ext. +90

Facility Contacts

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Etem Öztürk, Mr.

Role: primary

5465632789 ext. +90

Ömer Dursun, Asst. Prof.

Role: backup

5426088687 ext. +90

References

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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.

Reference Type BACKGROUND
PMID: 12544957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19465371 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28838857 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24614255 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31021691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30664500 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17013656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32178655 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34663421 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17204882 (View on PubMed)

Other Identifiers

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BEUFTR-4

Identifier Type: -

Identifier Source: org_study_id

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