View older revisions Content changed at 2021-02-07, 1399/11/19

Protocol summary

Study aim
The aims of the present study are to investigate and compare the effects of deep neck muscles specific exercises versus general exercises on pain, disability, functional indices, and neck muscles' thicknesses in patients with chronic non-specific neck pain.
Design
Single-blinded randomized control trial.
Settings and conduct
Participants will be assigned to one of the two exercise groups, specific neck exercises versus general exercises. specific neck exercises: nodding with and without eye movement, isometric head extension. General exercises: active range of motion of the neck and the shoulder joint.The primary outcomes: pain, disability, and neck muscles' thicknesses. The secondary outcomes: sleep quality, fear-avoidance, and quality of life. The day before starting the 8-week exercise program and the day after finalizing it the primary and secondary outcomes will be measured. participants will be blinded. None of the participants will be aware of the other training group
Participants/Inclusion and exclusion criteria
A total number of 64 patients with chronic non-specific neck will participate in this study. The inclusion criteria for this study include the presence of neck pain for at least 3 months in the past year with a pain intensity of 30 mm or more on the visual analog scale. Patients with acute neck pain or any history of spinal congenital deformity, trauma, surgery, and inflammatory diseases will be excluded.
Intervention groups
Two intervention groups including specific and general neck exercise groups. Deep neck muscles specific exercises: nodding with and without eye movement, isometric head extension. General exercises: active range of motion of the neck, shoulder joint, seated push-up, and shoulder shrugs.
Main outcome variables
pain, disability and neck muscles thicknesses, and cervical joint repositioning error (added in the amendment)

General information

Reason for update
To adapt the new version of IRCT software
Acronym
IRCT registration information
IRCT registration number: IRCT2017091620787N2
Registration date: 2017-11-11, 1396/08/20
Registration timing: prospective

Last update: 2021-02-07, 1399/11/19
Update count: 1
Registration date
2017-11-11, 1396/08/20
Registrant information
Name
Leila Rahnama
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0039
Email address
l.rahnama@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2017-11-15, 1396/08/24
Expected recruitment end date
2019-03-18, 1397/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of deep neck muscles specific training compared to general training on pain, disability, functional indices and neck muscles thicknesses in patients with chronic non-specific neck pain
Public title
The effects of neck specific and general exercises on pain and functional indices in patients with neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A positive history of neck pain for at least three months in the past year Pain intensity of more than 30 mm on visual analogue scale Non-specific neck pain
Exclusion criteria:
Acute neck pain A positive history of spine surgery Cervical Fracture or tumor Discopathy or radicular pain distributed in to shoulder or presence of any neurogenic signs History of cervical trauma or car accident Congenital spinal abnormality Systemic inflammatory diseases Vertigo and vestibular disorders Diabetes Receiving any shoulder or neck muscles training , physiotherapy or manual therapy on the neck in the past 6 months
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using sealed envelopes. Each participant will choose one of the sealed envelopes to be allocated to one of the exercise groups. The envelope will then be returned to the envelope box. Randomization will be carried out by someone who is not involved in evaluation or treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
None of the participants will be aware of the other training group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Board, University of Social Welfare and Rehabilitation Sciences
Street address
Velenjak, Koudakyar dead end
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2017-09-25, 1396/07/03
Ethics committee reference number
IR.USWR.REC.1396.194

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
One day before the starting the exercise program and one day after finalizing the 8-week exercise program. Pain will also be measured before and immediately after each exercise session.
Method of measurement
visual analog scale

2

Description
Disability
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Neck disability index (NDI) questionnaire, Persian version

3

Description
Neck muscle thickness
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Ultrasound device with a 45-millimeter linear array probe and frequency of 12 MHz for neck flexor muscles and 6 MHz for neck extensor muscles.

4

Description
Cervical Joint Position Error
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Subjects had to rotate their head from a relaxed position, turn to one direction and return to the original position. A laser pointer was used to measure the cervical joint repositioning error. The angle between the target and reference point in degrees will be defined as the joint position error. This variable has been added to the trial when IRB approval was received for the additions to the main protocol.

Secondary outcomes

1

Description
Sleep quality
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Pittsburgh Sleep Quality Index, Persian version

2

Description
Neck range of motion
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Goniameter

3

Description
Neck Muscles Maximum Isometric Voluntary Contraction
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Tensiometer unit for extensor muscles and Pressure Biofeedback Unit for flexor muscles

4

Description
Quality of life
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Sf-36 questionnaire, Persian version

5

Description
Fear avoidance
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Tampa Scale of Kinesiophobia, Persian version

Intervention groups

1

Description
Deep neck muscles specific exercises: 1) IN the supine position, the participant moves his/her eyes upward without any movement on the head and neck as much as possible and holds it for 5 seconds. Then the participant moves his/her eyes downward as much as possible and holds it for 5 seconds. 2) In the supine position the participant performs a light isometric nodding along with moving his/her eyes from forward to downward. A gentle pressure will be applied to the participant’s chin with his/her own hand. This exercise will be held for 5 seconds. 3) In the supine position the participant presses his/her occiput area with submaximal pressure to the bed and holds it for 5 seconds. 4) In the supine position the participant performs the nodding exercise by closing his/her chin to the sternum and holds it for 5 seconds. All exercises will be performed three times a week, three trials in a day, and five repetitions in each trial. One trial will be performed under the examiner supervision and the other two trials will be performed by the participants themselves. The aim is to improve the exercises to 20 repetitions in each trial.
Category
Rehabilitation

2

Description
General exercises: 1) Neck active free range of motion in flexion, extension, bilateral side flexion and bilateral rotation while the participant is seated. 2) Shoulder active free range of motion in flexion, extension, abduction, adduction and internal and external rotation while the participant is seated. 3) Seated push-ups. 4) Seated shoulder shrug exercise while the participant holds a one Kg weight in his/her hands. All exercises will be performed three times a week, three trials in a day, and five repetitions in each trial. One trial will be performed under the examiner supervision and the other two trials will be performed by the participants themselves. The aim is to improve the exercises to 20 repetitions in each trial.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Social Welfare and Rehabilitation Scienses and the related hospitals
Full name of responsible person
Pegah Kashfi
Street address
velenjak, koudakyar dead end
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
pegah.kashfi@yahoo.com

2

Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences and its related hospitals
Full name of responsible person
Pegah Kashfi
Street address
Velenjak, Koudakyar dead end
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
pegah.kashfi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr. Hamid-Reza Khankeh
Street address
Velenjak, Koudakyar dead end
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
pegah.kashfi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation 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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Pegah Kashfi
Position
Physiotherapy MSc student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
velengak, koudakyar dead end
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 22180084
Fax
Email
pegah.kashfi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Scienses
Full name of responsible person
Dr. Leila Rahnama
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
velenjak, koudakyar dead end
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 22180084
Fax
Email
l.rahnama@uswr.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social welfare and Rehabilitation Sciences
Full name of responsible person
Dr. Leila Rahnama
Position
PhD, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
velenjak, Koudakyar dead end
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0085
Fax
Email
lrahnama@gmail.com
Web page address

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
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