Local Vibration in Cervical Radiculopathy

Cervical Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06381011
• Other study ID #: BEUFTR-4
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: Bitlis Eren University
• Contact: Ömer Dursun, Asst. Prof.
• Phone: 5426088687
• Email: fztomrdrsn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, while patients in the second group will undergo local vibration application.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: September 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1. Between the ages of 18 and 70,
• 2. Three of four tests of clinical prediction rule for cervical radiculopathy are positive (spurling test, distraction test, upper limb tension test 1, and ipsilateral cervical rotation less than 60 degrees)
• 3. Unilateral paresthesia, upper extremity, and neck 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) of 30 kg/cm2 or higher,
• 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

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Bitlis Eren University	Bitlis	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Bitlis Eren University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Phys Ther. 2009 Nov;89(11):1254-5. Phys Ther. 2010 May;90(5):825. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Change from baseline neck pain immediately and five days after the intervention
Secondary	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
Secondary	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 lying face down on the treatment table with their arms hanging loose, 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