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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical Range of Motion | The immediate and short-term effect of local vibration intervention on cervical range of motion will be measured using a 10-inch standard manual goniometer. To measure cervical flexion and extension range of motion, the pivot point of the goniometer will be placed at the external auditory meatus. The fixed arm of the goniometer will be held vertically, and the moving arm will follow along the base of the nostrils. For measuring cervical rotation range of motion, measurements will be taken from behind the participants. The pivot point of the goniometer will be placed at the vertex, while the fixed arm will be kept parallel to the acromion, and the moving arm will follow along with their nose. Lateral flexion range of motion will be taken in front of the participants. The pivot point of the goniometer will be placed over the sternal notch, with its fixed arm parallel to the acromion, and its moving arm will follow along the tip of the participants' nose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ömer Dursun, Asst. Prof. | Contact | 5426088687 | +90 | fztomrdrsn@gmail.com |
| Erhan Dincer, M.Sc. | Contact | 5442543857 | +90 | fzterhan@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ömer Dursun, Asst. Prof. | Bitlis Eren University | Principal Investigator |
| Gökmen Reyhanlı, M.D. | Bitlis Tatvan State Hospital | Principal Investigator |
| Erhan Dincer, M.Sc. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bitlis Tatvan State Hospital | Recruiting | Bitlis | Tatvan | 13200 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12544957 | Background | 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. | |
| 19465371 | 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. |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D019547 | Neck Pain |
| D010292 | Paresthesia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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The evaluator and the researcher administering the local vibration application will be different. Patients will be blinded to their group assignment.
| Change from baseline neck pain immediately and five days after the intervention |
| The Change in the Pressure Pain Threshold of the Upper Trapezius | The potential impact of local vibration intervention on patients' pain thresholds will be evaluated using an analog algometer. Pain threshold measurements will be taken at the upper trapezius muscle. The algometer will be positioned perpendicular to the measurement areas. Three measurements will be taken for each region, with a half-minute interval between measurements. The average of the three measurements will be calculated and recorded. A change of 20-25% in the algometric measurement values will be considered significant. | Change from baseline neck pain immediately and five days after the intervention |
| The Change in the Viscoelastic Properties of the Upper Trapezius | The effect of local vibration intervention on the viscoelastic properties of patients' upper trapezius will be measured using the myotonometer (MyotonPRO). The upper trapezius myometric measurement will be taken with the patient seated on a chair with hands placed over knees, and measured from the midpoint between the C7 spinous process and the acromion. | Change from baseline neck pain immediately and five days after the intervention |
| Bitlis Eren University |
| Principal Investigator |
| Abdurrahman Tanhan, Ph.D. | Bitlis Eren University | Principal Investigator |
| Etem Öztürk | Bitlis Tatvan State Hospital | Principal Investigator |
| 28838857 | 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. |
| 24614255 | 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. |
| 31021691 | 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. |
| 30664500 | 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. |
| 17013656 | 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. |
| 32178655 | 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. |
| 34663421 | 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. |
| 17204882 | 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |