Study Results
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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RECRUITING
NA
34 participants
INTERVENTIONAL
2024-08-05
2024-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Bitlis Eren University
OTHER
Responsible Party
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Omer Dursun
Asst. Prof.
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)
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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BEUFTR-4
Identifier Type: -
Identifier Source: org_study_id
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