NCT06139263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2024

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

November 14, 2023

Last Update Submit

June 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Neck Disability Index

    10 minutes

  • Visual Analogue Scale

    5 minutes

  • Kinesiophobia

    10 minutes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Vibration Group

EXPERIMENTAL

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)Other: conventional treatment program

Interventions

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.

Vibration Group

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.

Control GroupVibration Group

Eligibility Criteria

Age40 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Those diagnosed with cervical disc herniation,
  • Having complained of neck pain for at least 3 weeks,
  • Individuals with limited neck joint range of motion.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul Medipol University

Istanbul, 34000, Turkey (Türkiye)

Location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Burak Menek, Phd

    Medipol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

October 20, 2023

Primary Completion

November 30, 2023

Study Completion

June 27, 2024

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations