Comparison of the Effect of whole Body Vibration Combined with Therapeutic Exercise Versus Therapeutic Exercise Alone on Pain, Disability, Strength and Endurance of Muscles in People with Non-Specific Neck Pain
Compare the Effects of Whole Body Vibration combined with Therapeutic Exercise and Therapeutic Exercise alone on Pain, Disability, Muscle Strength and Endurance in People with Non-Specific Neck Pain.
Design
A clinical trial with control and intervention groups, with parallel groups, single-blind, simple randomized design. 24 patients were assigned to two groups using randomization software.
Settings and conduct
Participants were divided into two intervention groups and a control group using a simple randomization method using randomization software. The intervention group received a whole-body vibration device and neck exercises for 6 weeks in the clinic. Neck exercises were performed at home for 6 weeks. The severity of pain and disability were assessed and the strength and endurance of the neck muscles were recorded at the end of week 6. Study location in Shahid Beheshti University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Neck pain for at least 3 months
Achieving a score of 3-6 on the Visual Pain Rating System
Neck pain for which a specialist physician has not mentioned a specific cause
Adults aged 25 to 50 years
Exclusion criteria:
Existence of a specific postural disorder
History of vestibular system disorders
History of any systemic disease and lack of general health
History of any surgery and fracture in the cervical and lumbar region
Failure to participate in a maximum of two training sessions during the rehabilitation period
Intervention groups
The control group received exercise therapy alone and the intervention group received exercise therapy combined with a whole-body vibration device for 6 weeks and 18 sessions. The level of pain, tracheal inflammation, and strength and endurance in the neck were measured before and after the intervention and compared.
Main outcome variables
Pain, Weakness, Strength, and Endurance of Neck Muscles
General information
Reason for update
Acronym
WBV
IRCT registration information
IRCT registration number:IRCT20250119064442N1
Registration date:2025-04-20, 1404/01/31
Registration timing:registered_while_recruiting
Last update:2025-04-20, 1404/01/31
Update count:0
Registration date
2025-04-20, 1404/01/31
Registrant information
Name
Fatemeh Arghoun
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4479 5411
Email address
bahar.arghon@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-04-09, 1404/01/20
Expected recruitment end date
2025-06-20, 1404/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of whole Body Vibration Combined with Therapeutic Exercise Versus Therapeutic Exercise Alone on Pain, Disability, Strength and Endurance of Muscles in People with Non-Specific Neck Pain
Public title
How adding Whole body vibration to Exercise affects Neck pain, Disability and Muscle performance in People withe Chronic Neck Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neck pain for at least 3 months
A score of 3-6 on the Visual Pain Rating System
Neck pain for which a specialist has not identified a specific cause
Adults between the ages of 25 and 50
Exclusion criteria:
Failure to participate in a maximum of two training sessions during the rehabilitation period
In case of vibration intolerance
Unwillingness to continue cooperation with the sample
Feeling dizzy
Blurred vision
Feeling nauseousry
Feeling of palpitations
Presence of musculoskeletal abnormalities in the upper body
Specific structural damage in the neck
Cervical disc protrusion and radiating nerve pain
Spinal surge
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method: Participants are divided into two treatment groups (exercise therapy and exercise therapy with global vibrations) using randomization software. The specialized sequence is secretly placed in numbered envelopes and administered by an independent individual.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are not informed of which treatment group (intervention or control) they are placed in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Unit 8, Block 18 east, Shahrak shahrdari, Km 14 shahid lashgari, Tehran
City
Tehran
Province
Tehran
Postal code
1396155143
Approval date
2024-05-05, 1403/02/16
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.033
Health conditions studied
1
Description of health condition studied
Chronic non-specific neck pain
ICD-10 code
M79.9
ICD-10 code description
Soft tissue disorder, unspecified
Primary outcomes
1
Description
Neck Functional Disability Scale
Timepoint
At the first session and at the end of the last therapy session
Method of measurement
Neck Disability index
2
Description
Pain level
Timepoint
At the first session and at the end of the last therapy session
Method of measurement
visual analog scale
3
Description
Muscle endurance
Timepoint
At the first session and at the end of the last therapy session
Method of measurement
In seconds
4
Description
Muscle strength
Timepoint
At the first session and at the end of the last therapy session
Method of measurement
Dynamometer
Secondary outcomes
1
Description
General questionnaire
Timepoint
Beginning of the first therapy session
Method of measurement
Questionnaire
Intervention groups
1
Description
In the intervention group, in addition to the therapeutic exercises that are also performed in the control group, a whole body vibration device is used.Intervention group:
Category
Rehabilitation
2
Description
Control group: Neck therapeutic exercises are performed at home for 6 weeks in this group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh arghoun
Street address
Unit 8, Block 18 East, Shahrak Shahrdariah, Km 14, Shahid Lashgari, Tehran
City
Tehran
Province
Tehran
Postal code
1396155143
Phone
+98 938 004 4735
Email
bahar.arghon@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Hoda Niknam
Street address
Unit 8, Block 18 East, Shahrak Shahrdariah, Km 14, Shahid Lashgari, Tehran
City
Tehran
Province
Tehran
Postal code
1396155143
Phone
+98 938 004 4735
Email
bahar.arghon@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Arghoun
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Unit 8, Block 18 East, Shahrak Shahrdariah, Km 14, Shahid Lashgari, Tehran
City
Tehran
Province
Tehran
Postal code
1396155143
Phone
+98 21 4479 5411
Fax
Email
bahar.arghon@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Arghoun
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Unit 8, Block 18 East, Shahrak Shahrdariah, Km 14, Shahid Lashgari, Tehran
City
Tehran
Province
Tehran
Postal code
1396155143
Phone
+98 21 4479 5411
Fax
Email
bahar.arghon@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Arghoun
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Shahid Lashgari Highway, Blvd. 47, Shahradari Township, East Block 18, Unit 8
City
Tehran
Province
Tehran
Postal code
1396155143
Phone
+98 21 4479 5411
Fax
Email
bahar.arghon@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available