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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06139263
Other study ID # E-10840098-772.02-1701
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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