Protocol summary

Study aim
Effect of motor control exercises on pain, range of motion, craniovertebral angle, proprioception, muscles endurance and neck disability index in patients
Design
Randomized double-blind randomized clinical trial on 30 patients
Settings and conduct
Patients with non-specific chronic neck pain are selected from the patients referred to the physiotherapy clinic of Tehran Rehabilitation School. In the first session, personal information and evaluation of the main consequences are recorded. There is a physiotherapist who is not aware of the results of the evaluations. Blinding is performed on patients, examiners, and therapists. Group assignments and interventions are performed by a physiotherapist who is not aware of the results of the evaluations.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) pain in the posterior region of the neck between the upper neckline to the spinous process of the first thoracic vertebra 2) At least three months have passed since the first sign of pain 3) Age range 18 to 45 years. Exclusion Criteria : 1) History of spinal surgery and disc-related diseases 2) History of neck fracture or tumor 3) Cervical spine instability 4) Existence of any peripheral or central nervous system disorders 5) Neck vascular disorders Tension
Intervention groups
Intervention group 1: Electrotherapy + muscle energy techniques + stretching exercises Intervention group 2: Control group interventions + a combination of movement control exercises of flexor muscles and deep neck extensor
Main outcome variables
Pain, neck active range of motion of the in the six main directions, craniovertebral angle neck proprioception, neck muscular endurance, Neck Disability Index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220122053793N1
Registration date: 2022-02-01, 1400/11/12
Registration timing: registered_while_recruiting

Last update: 2022-02-01, 1400/11/12
Update count: 0
Registration date
2022-02-01, 1400/11/12
Registrant information
Name
Atefe Najafi Visroudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
atefenajafi.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-25, 1400/11/05
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Motor Control Training on Neck Disability Index, Proprioception and Craniovertebral Angle in Patients with Chronic Non-Specific Neck Pain: A Randomized Controlled Trial
Public title
Effect of Motor Control Training in Patients with Chronic Non-Specific Neck Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
)Occurrence of neck pain by touch, movement, or prolonged fixed positions of the neck in the posterior region of the neck between the upper neck line to the prickly appendage of the first thoracic vertebra At least three months have passed since the first sign of pain 2Pain intensity greater than 3 on the numerical pain rating scale A score greater than or equal to 10 in the Persian version of the Neck Disability Index Questionnaire Age range 18 to 45 years
Exclusion criteria:
History of spinal surgery and disc-related diseases History of neck fracture or tumor Cervical spine instability Presence of any peripheral or central nervous system disorders Neck vascular disorder History Accident or trauma to the neck Receiving physiotherapy treatment in the last three months
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
According to the number of patients in each group, the type of treatment is written on a piece of paper as "control group treatment" or "intervention group treatment" and placed in opaque's sealed envelopes. Randomly removes one of the envelopes and treats the patient based on the type of treatment specified in it. And the envelopes are mixed again.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double-blinded . The participant will be blinded to the type of intervention in relation to their treatment group as well as the researcher who must enter the data into the relevant checklist.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Faculty of Rehabilitation, Pich Shemiran,Enghelab St.
City
Tehran
Province
Tehran
Postal code
11489-65111
Approval date
2022-01-15, 1400/10/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1218

Health conditions studied

1

Description of health condition studied
Chronic Non-Specific Neck Pain
ICD-10 code
R52.2
ICD-10 code description
Other chronic pain

Primary outcomes

1

Description
Pain
Timepoint
Before the intervention the end of the tenth session and the end of the sixth week.
Method of measurement
NPRS (Numeric Pain Rating Scale) - VAS (Visual Analogue Scale)

2

Description
Active Range Of Motion in 6 main directions
Timepoint
Before the intervention the end of the tenth session and the end of the sixth week.
Method of measurement
Manual Goniometer

3

Description
Craniovertebral Angle
Timepoint
Before the intervention the end of the tenth session and the end of the sixth week.
Method of measurement
Photogrammetry

4

Description
Neck Proprioception
Timepoint
Before the intervention the end of the tenth session and the end of the sixth week.
Method of measurement
Cervical Joint Position Error (JPE) test

5

Description
Neck Muscle Endurance
Timepoint
Before the intervention the end of the tenth session and the end of the sixth week.
Method of measurement
Cervical Extensor Endurance Test (CEET) Neck Flexor Endurance Test (NFET)

6

Description
Neck Disability Index
Timepoint
Before the intervention the end of the tenth session and the end of the sixth week.
Method of measurement
Persian Version of Neck Disability Index Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In the first 10 sessions, for patients, first for 20 minutes hi-TENS (Conventional TENS) current and then for fifteen minutes the heat pack heat modality is used in the neck area. Muscle energy techniques for muscles Upper trapezius and Levator scapula, Suboccipital and sternocleidomastoid with post-contraction relaxation technique with 20% of maximum voluntary isometric contraction for seven seconds and 3 times per side in each session.
Category
Rehabilitation

2

Description
Intervention group: Control group interventions + a combination of deep neck flexor and extensor muscles motor control exercises With seven to ten repetitions of each exercise twice a day.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic of Tehran Rehabilitation School
Full name of responsible person
Atefe Najafi Visroudi
Street address
Faculty of Rehabilitation, corner of Safi Alisha St., , Pich Shemiran, Enghelab St.
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 3939
Fax
+98 21 7753 4133
Email
rehabilitation@tums.ac.ir
Web page address
https://rehab.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hamid Dalvand
Street address
Faculty of Rehabilitation, Pich Shemiran,Enghelab St.
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7752 8205
Fax
+98 21 7753 4133
Email
hdalvand@sina.tums.ac.ir
Web page address
https://rehab.tums.ac.ir/section23/page34/lang/Fa.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Atefe Najafi Visroudi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitations, Enghelab St.
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Fax
+98 21 7753 4133
Email
atefenajafi.a@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atefe Najafi Visroudi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitations, Enghelab St.
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Fax
+98 21 7753 4133
Email
atefenajafi.a@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atefe Najafi Visroudi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitations, Enghelab St.
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Fax
+98 21 7753 4133
Email
atefenajafi.a@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Raw study data and analysis will be provided to researchers upon request.
When the data will become available and for how long
After the publication of articles resulting from the research
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
The data are only available to other researchers to study and evaluate treatment outcomes.
From where data/document is obtainable
By sending an email to the responsible author
What processes are involved for a request to access data/document
By sending an email to the responsible author And documentary demand
Comments
Loading...