The Effect of Vibration Therapy on Pain, Functionality and Proprioception in İndividuals With Cervical Disc Herniation

Pain Clinical Trial

Official title:

The Effect of Vibration Therapy on Pain, Functionality and Proprioception in İndividuals With Cervical Disc Herniation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139263
• Other study ID #: E-10840098-772.02-1701
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: March 2024
• Source: Medipol University
• Contact: Emre Dansuk, Msc
• Phone: +90 5377790434
• Email: edansuk[@]medipol.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Disc Herniation
• Functionality
• Hernia
• Intervertebral Disc Displacement
• Pain
• Proprioception
• Vibration Therapy

Intervention

Device:
• a percussion massage gun (Compex Fix 2.0)
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.

Other:
• 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. 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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Joint Position Sense	Patients' joint position sense will be evaluated with the Laser Cursor Assisted Angle Repetition Test (LI-YATT).	10 minutes
Secondary	Neck Disability Index	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
Secondary	Visual Analogue Scale	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
Secondary	Kinesiophobia	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.S. 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