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

Sponsor
Medipol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06139263
Collaborator
(none)
44
2
2
1.3
22
16.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: a percussion massage gun (Compex Fix 2.0)
  • Other: conventional treatment program
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Vibration Therapy on Pain, Functionality and Proprioception in İndividuals With Cervical Disc Herniation
Actual Study Start Date :
Oct 20, 2023
Anticipated Primary Completion Date :
Nov 20, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Evaluation of Joint Position Sense [10 minutes]

    Patients' joint position sense will be evaluated with the Laser Cursor Assisted Angle Repetition Test (LI-YATT).

Secondary Outcome Measures

  1. Neck Disability Index [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.

  2. Visual Analogue Scale [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.

  3. Kinesiophobia [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medipol University Istanbul Turkey 34000
2 Istanbul Medipol University Istanbul Turkey

Sponsors and Collaborators

  • Medipol University

Investigators

  • Study Director: Burak Menek, Phd, Medipol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emre DANSUK, Lecturer, Medipol University
ClinicalTrials.gov Identifier:
NCT06139263
Other Study ID Numbers:
  • E-10840098-772.02-1701
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 21, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 21, 2023