- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06139263
The Effect of Vibration Therapy on Pain, Functionality and Proprioception in İndividuals With Cervical Disc Herniation
This study aimed to examine the effects of vibration applied at different frequencies with a percussion massage gun on joint range of motion, pain, functionality and kinesiophobia in individuals with cervical disc herniation.All individuals participating in the study will receive a conventional treatment program. In the conventional treatment program, heat will be applied to the neck area for 20 minutes and TENS (100 Hz) will be applied to the painful area. Additionally, patients will be given joint range of motion (ROM) exercises under the supervision of a physiotherapist.
Vibration Group Vibration application will be applied to the individuals in this group in addition to conventional methods. Vibration application will be applied to the trapezius, levator scapula and cervical paravertebral muscles with a percussion massage gun (Compex Fix 2.0) along the origo-insersio line for 3 minutes for each muscle group. Vibration application will be made with the soft head of the percussion massage gun. Vibration therapy will be applied 3 days a week for 3 weeks.
Study Overview
Status
Intervention / Treatment
Detailed Description
This study aimed to examine the effects of vibration applied at different frequencies with a percussion massage gun on joint range of motion, pain, functionality and kinesiophobia in individuals with cervical disc herniation.All individuals participating in the study will receive a conventional treatment program 4 days a week. In the conventional treatment program, heat will be applied to the neck area for 20 minutes and TENS (100 Hz) will be applied to the painful area. Additionally, patients will be given joint range of motion (ROM) exercises under the supervision of a physiotherapist. Patients will be asked to perform ROM exercises in 2 sets of 10 repetitions, holding for 2 seconds at the end point in all directions. As a strengthening exercise, isometric exercises will be given in the flexion extension, right and left lateral flexion directions by waiting for 6 seconds at the end point. Isometric exercises will be performed in 2 sets of 10 repetitions with 1 minute rest between sets.
Vibration Group Vibration application will be applied to the individuals in this group in addition to conventional methods. Vibration application will be applied to the trapezius, levator scapula and cervical paravertebral muscles with a percussion massage gun (Compex Fix 2.0) along the origo-insersio line for 3 minutes for each muscle group. Vibration application will be made with the soft head of the percussion massage gun. Vibration therapy will be applied 3 days a week for 3 weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Istanbul Medipol University
-
Istanbul, Turkey, 34000
- Istanbul Medipol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Those diagnosed with cervical disc herniation,
- Having complained of neck pain for at least 3 weeks,
- Individuals with limited neck joint range of motion.
Exclusion Criteria:
- Those who have another orthopedic or neurological disorder in addition to their neck problem,
- Having a history of previous trauma in the neck area,
- Included in the physiotherapy program in the last 6 months,
- Individuals who cannot tolerate vibration application.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
All individuals participating in the study will receive a conventional treatment program 4 days a week.
In the conventional treatment program, heat will be applied to the neck area for 20 minutes and TENS (100 Hz) will be applied to the painful area.
Additionally, patients will be given joint range of motion (ROM) exercises under the supervision of a physiotherapist.
Patients will be asked to perform ROM exercises in 2 sets of 10 repetitions, holding for 2 seconds at the end point in all directions.
As a strengthening exercise, isometric exercises will be given in the flexion extension, right and left lateral flexion directions by waiting for 6 seconds at the end point.
Isometric exercises will be performed in 2 sets of 10 repetitions with 1 minute rest between sets.
|
In the conventional treatment program, heat will be applied to the neck area for 20 minutes and TENS (100 Hz) will be applied to the painful area.
Additionally, patients will be given joint range of motion (ROM) exercises under the supervision of a physiotherapist.
Patients will be asked to perform ROM exercises in 2 sets of 10 repetitions, holding for 2 seconds at the end point in all directions.
As a strengthening exercise, isometric exercises will be given in the flexion extension, right and left lateral flexion directions by waiting for 6 seconds at the end point.
Isometric exercises will be performed in 2 sets of 10 repetitions with 1 minute rest between sets.
|
|
Experimental: Vibration Group
Vibration application will be applied to the individuals in this group in addition to conventional methods.
Vibration application will be applied to the trapezius, levator scapula and cervical paravertebral muscles with a percussion massage gun (Compex Fix 2.0) along the origo-insersio line for 3 minutes for each muscle group.
Vibration application will be made with the soft head of the percussion massage gun.
Vibration therapy will be applied 3 days a week for 3 weeks.
|
In the conventional treatment program, heat will be applied to the neck area for 20 minutes and TENS (100 Hz) will be applied to the painful area.
Additionally, patients will be given joint range of motion (ROM) exercises under the supervision of a physiotherapist.
Patients will be asked to perform ROM exercises in 2 sets of 10 repetitions, holding for 2 seconds at the end point in all directions.
As a strengthening exercise, isometric exercises will be given in the flexion extension, right and left lateral flexion directions by waiting for 6 seconds at the end point.
Isometric exercises will be performed in 2 sets of 10 repetitions with 1 minute rest between sets.
Vibration application will be applied to the individuals in this group in addition to conventional methods.
Vibration application will be applied to the trapezius, levator scapula and cervical paravertebral muscles with a percussion massage gun (Compex Fix 2.0) along the origo-insersio line for 3 minutes for each muscle group.
Vibration application will be made with the soft head of the percussion massage gun.
Vibration therapy will be applied 3 days a week for 3 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of Joint Position Sense
Time Frame: 10 minutes
|
Patients' joint position sense will be evaluated with the Laser Cursor Assisted Angle Repetition Test (LI-YATT).
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index
Time Frame: 10 minutes
|
The Neck Disability Index (NDI) scale will be used to evaluate neck disability.
NDI is an easy-to-apply, reliable, and validated index used by Vernon and Mior to measure pain and limitations in daily living activities caused by neck pathologies.
This index consists of 10 parts with headings such as severity of pain, lifting loads, reading, headache, personal care, business life, concentration, sleep, recreational activities and driving, and there are 6 answers for each heading ranging from 0 to 5 points.
0 indicates that there is no pain or any functional limitation, while 5 indicates that the most pain and limitation is present.
|
10 minutes
|
|
Visual Analogue Scale
Time Frame: 5 minutes
|
Visual Analogue Scale (VAS) will be used to evaluate the pain intensity of patients.
VAS consists of a 10 cm long horizontal line.
'0' represents no pain, '10' represents unbearable pain.
During our evaluation, patients will be asked to mark the level of pain they feel on this chart, and the distance to the starting point will be measured and recorded with the ruler.
|
5 minutes
|
|
Kinesiophobia
Time Frame: 10 minutes
|
The patients' kinesiophobia will be evaluated with the Tampa Kinesiophobia Scale (TKÖ).
This scale was developed by Kori et al. to evaluate patients' fear of movement.
It is a 17-question scale prepared by A.Ş. in 1990 and has Turkish validity and reliability.
The scoring of this 4-point Likert type scale is; "strongly disagree" is 1, "disagree" is 2, 26 "agree" is 3, "strongly agree" is 4. A total score is calculated after reversing the 4th, 8th, 12th and 16th items.
The person receives a total score between 17-68.
The higher the score a person gets on the scale, the higher the degree of kinesiophobia.
|
10 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Burak Menek, Phd, Medipol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-772.02-1701
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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