Cervical RadiculopathyNCT06381011
Local Vibration in Cervical Radiculopathy
A study testing Local Vibration in people with Cervical Radiculopathy, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Local Vibration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bitlis Tatvan State Hospital
Bitlis, Tatvan, 13200
Etem Öztürk, Mr., 5465632789 ext. +90, fztetem2121@gmail.com
Ömer Dursun, Asst. Prof., 5426088687 ext. +90, fztomrdrsn@gmail.com
About this study
Official title: Can Local Vibration be Used to Alleviate Symptoms of Cervical Radiculopathy?
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.
Read the detailed 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 in addition to conventional treatment, while patients in the second group will receive local vibration application in addition to conventional treatment
- Conditions
- Cervical Radiculopathy
- Being tested
- Local Vibration
- Keywords
- neck pain, paresthesia
- Medical subject headings
- Radiculopathy, Neck Pain, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local VibrationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Local Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.'
Measured: 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.'
Measured: 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.'
Measured: Change from baseline neck pain immediately and five days after the intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline neck pain immediately and five days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start5 Aug 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Dursun, Bitlis Eren University
- Investigators
- Ömer Dursun, Asst. Prof., Principal investigator, Bitlis Eren UniversityGökmen Reyhanlı, M.D., Principal investigator, Bitlis Tatvan State HospitalErhan Dincer, M.Sc., Principal investigator, Bitlis Eren UniversityAbdurrahman Tanhan, Ph.D., Principal investigator, Bitlis Eren UniversityEtem Öztürk, Principal investigator, Bitlis Tatvan State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381011
- Sponsor's protocol ID
- BEUFTR-4
- Status last verified
- Aug 2024
- First submitted
- 17 Apr 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12544957Young 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.
PubMed 19465371Thoomes 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.
PubMed 28838857Wong 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.
PubMed 24614255Young 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.
PubMed 31021691Ayub 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.
PubMed 30664500Rubinstein 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.
PubMed 17013656Taso 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.
PubMed 32178655Alshami 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.
PubMed 34663421Abbed 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.
PubMed 17204882
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Local Vibration be Used to Alleviate Symptoms of Cervical Radiculopathy?
- ClinicalTrials.gov ID
- NCT06381011
- Acronym / sponsor ID
- BEUFTR-4
- Conditions
- Cervical Radiculopathy
- Keywords
- neck pain, paresthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Local Vibration Group | Sham comparator | Other: Local VibrationIn 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 Intervention Group | Experimental | Other: Local VibrationIn 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local VibrationThe patients in the study group will receive local vibration application including different frequency values on the neck and back regions for five consecutive days. | Other | Local Vibration Intervention Group, Sham Local Vibration Group |
Primary outcome
Neck Pain
Time frame: Change from baseline neck pain immediately and five days after the intervention
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.'
Upper Limb Pain
Time frame: Change from baseline neck pain immediately and five days after the intervention
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.'
Paresthesia
Time frame: Change from baseline neck pain immediately and five days after the intervention
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.'
3 secondary outcomes
Cervical Range of Motion
Time frame: Change from baseline neck pain immediately and five days after the intervention
The Change in the Pressure Pain Threshold of the Upper Trapezius
Time frame: Change from baseline neck pain immediately and five days after the intervention
The Change in the Viscoelastic Properties of the Upper Trapezius
Time frame: Change from baseline neck pain immediately and five days after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Background: PubMed 12544957Wainner 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.
- Background: PubMed 19465371Young 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.
- Background: PubMed 28838857Thoomes 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.
- Background: PubMed 24614255Wong 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.
- Background: PubMed 31021691Young 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.
- Background: PubMed 30664500Ayub 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.
- Background: PubMed 17013656Rubinstein 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.
- Background: PubMed 32178655Taso 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.
- Background: PubMed 34663421Alshami 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.
- Background: PubMed 17204882Abbed 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ömer Dursun, Asst. Prof. principal investigator
Bitlis Eren University
Gökmen Reyhanlı, M.D. principal investigator
Bitlis Tatvan State Hospital
Erhan Dincer, M.Sc. principal investigator
Bitlis Eren University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Vibration in people with Cervical Radiculopathy, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ömer Dursun, Asst. Prof. (5426088687 ext. +90, fztomrdrsn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Pain (time frame: Change from baseline neck pain immediately and five days after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06381011, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024; AzTrials last refreshed its copy on 31 Oct 2026.