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The effect of axioscapular muscles release technique on the thickness of axioscapular and neck stabilizer muscles in patients with nonspecific neck pain: A Randomized Clinical Controlled Trial

Protocol summary

Study aim
The aims of this study were to investigate the effect of axioscapular muscle release technique on the thickness of upper and middle trapezius and cross section of cervical multifidus and longus colli, pressure pain threshold, pain intensity and neck disability index, before and after of the intervention for patients with nonspecific neck pain and also compare these parameters with the control group.
Design
Clinical trial with control group, parallel groups, a control group and the other intervention group, single blind, randomized allocation, each group has 15 patients
Settings and conduct
This study will be done at Imam Clinic in Tabriz. Subjects in the intervention group will be treated for 3 days in a week for 10 sessions. The intervention group will be treated by routine physiotherapy and axioscapular muscle release technique. control group will be treated by routine physiotherapy. In this study, the assessors will be blind, they will not know how to randomize patients.
Participants/Inclusion and exclusion criteria
The patients with Visual Analogue Scale of neck pain at least 3 maximum 7,Neck Disability Index at least 10, maximum 40, have chronic neck pain and normal Body Mass Index were included in the study. people with neurological symptoms in their upper limbs, history of surgery, trauma in the neck and scapula. Women who are pregnant, Patients who have a pacemaker, malignancy, systemic rheumatic diseases and people who received scapular muscle release treatment 1 month before the study started were excluded from this study
Intervention groups
control group Will be treated by routine physiotherapy and intervention group will be treated by routine physiotherapy and axioscapular muscle release technique
Main outcome variables
thickness of upper and middle trapezius, cross sectional of longus colli, cervical multifidus; pain intensity; neck disability and pressure pain threshold

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210524051386N1
Registration date: 2021-12-27, 1400/10/06
Registration timing: prospective

Last update: 2021-12-27, 1400/10/06
Update count: 0
Registration date
2021-12-27, 1400/10/06
Registrant information
Name
Bahram Amirshakeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3384 5381
Email address
amirshakerib@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2022-05-10, 1401/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of axioscapular muscles release technique on the thickness of axioscapular and neck stabilizer muscles in patients with nonspecific neck pain: A Randomized Clinical Controlled Trial
Public title
The effect of scapular muscles release technique on the thickness of scapular and neck muscles in patients with nonspecific neck pain: A Randomized Clinical Controlled Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients whose nonspecific neck pain has been diagnosed by a neurosurgeon According to the physiotherapist, at least one active trigger point in the axioscapular muscles (upper trapezius and middle trapezius) Visual Analogue Scale of neck pain at least 3, maximum 7 Neck Disability Index at least 10, maximum 40 At least three months have passed since the onset of neck pain Normal Body Mass Index between 20 and 25
Exclusion criteria:
The patients with neurological symptoms and radiculopathy in their upper extremities Patients who have a pacemaker in the heart Patients with a history of surgery in the neck and scapula Patients who have a systemic rheumatic diseases Patients with congenital malformations in the neck and scapula Women who are pregnant Patients with a history of trauma in the neck and scapula Patients who have malignancy People who received scapular muscle release treatment 1 month before the study started
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with non-specific neck pain who participated in this study will be divided into two groups A, B randomly, by statistical random allocation software. Then, for the ordering of people, randomly by software will be taken by the same person who is not a member of the project group.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a single blind study. In this study, the patients were not blind. The physiotherapist whose duty is patients physiotherapy treatment is also not blind. However, the physiotherapist whose duty is to evaluate at the beginning and end of the physiotherapy sessions is blind, and the radiologist whose duty is to ultrasound the muscles at the beginning and the end of the physiotherapy sessions is blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Tabriz University of Medical Sciences
Street address
Rehabilitation Faculty of Tabriz University of Medical Sciences, Next to Vahdat Hall, Tabriz University, 29 Bahman Blvd, Tabriz City, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Approval date
2021-10-25, 1400/08/03
Ethics committee reference number
IR.TBZMED.REC.1400.715

Health conditions studied

1

Description of health condition studied
Chronic nonspecific neck pain
ICD-10 code
G89.29
ICD-10 code description
Other chronic pain

Primary outcomes

1

Description
Thickness of upper trapezius, middle trapezius
Timepoint
Beginning of the study (before the intervention) and after the end of treatment sessions (10 sessions later)
Method of measurement
sonography siemens healthineers - acuson juniper

2

Description
cross sectional of longus colli, cervical multifidus
Timepoint
Beginning of the study (before the intervention) and after the end of treatment sessions (10 sessions later)
Method of measurement
sonography siemens healthineers - acuson juniper

Secondary outcomes

1

Description
Pain intensity
Timepoint
Beginning of the study (before the intervention) and after the end of treatment sessions (10 sessions later)
Method of measurement
Visual Analogue Scale

2

Description
Pressure Pain Threshold
Timepoint
Beginning of the study (before the intervention) and after the end of treatment sessions (10 sessions later)
Method of measurement
Digital Algometer

3

Description
neck disability
Timepoint
Beginning of the study (before the intervention) and after the end of treatment sessions (10 sessions later)
Method of measurement
Neck Disability Index Questionnaire (Iranian version)

Intervention groups

1

Description
intervention group: will be treated by routine physiotherapy and axioscapular muscle release technique, the routine physiotherapy including exercise therapy will be used as stretching exercises of shortened cervical muscles and strengthening weakened neck muscles, we will be used TENS which is conventional mode for 20 minutes, frequency of 100 Hz, period of 60 milliseconds and tolerable intensity for the patient. The electrodes will be placed on both sides of the cervical vertebrae and the patient will be in a prone position, the ultrasound: that the patient is in a prone position and for 2 minutes, with 50% pulse, with frequency of 1 MHz and intensity of 1.5 on the sub occipital muscles will be performed, hot pack: will be performed on the cervical area for 20 minutes. And also patients counseling and training in terms of how to use the phone properly and ... In a training file, and they will be treated by special myofacial release technique in the axioscapular muscles (upper and middle trapezius) for them.
Category
Rehabilitation

2

Description
Control group: will be treated by routine physiotherapy, the routine physiotherapy including exercise therapy will be used as stretching exercises of shortened cervical muscles and strengthening weakened neck muscles, we will be used TENS which is conventional for 20 minutes, frequency of 100 Hz, period of 60 milliseconds and tolerable intensity for the patient. The electrodes will be placed on both sides of the cervical vertebrae and the patient will be in a prone position, the ultrasound that the patient is in a prone position and for 2 minutes, with 50% pulse, with frequency of 1 MHz and intensity of 1.5 on the sub occipital muscles will be performed, hot pack: will be performed on the cervical area for 20 minutes. And also patients counseling and training in terms of how to use the phone properly and... In a training file.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Clinic
Full name of responsible person
Reza Bahrami Ilkhchi( neurosurgeon, assistant professor)
Street address
Golshahr, Elgoli Road,Tabriz City
City
Tabriz
Province
East Azarbaijan
Postal code
5167846171
Phone
+98 41 3389 3787
Email
rbahrami1400@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shabi
Street address
Third floor, No 2 Central building, Golgasht Ave, Tabriz University of Medical Sciences, Tabriz City
City
Tabriz
Province
East Azarbaijan
Postal code
5166614776
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Amirshakri
Position
Assistant Professor, supervisor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilition Faculity of Tabriz University of Medical Sciences, Next to Vahdat Hall, Tabriz University, 29 Bahman Blvd, Tabriz City
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 5359
Email
amirshakerib@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Amirshakeri
Position
Assistant professor, supervisor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilition Faculity of Tabriz University of Medical Sciences, Next to Vahdat Hall, Tabriz University, 29 Bahman Blvd, Tabriz City
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3384 5381
Fax
Email
amirshakerib@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Amirshakeri
Position
Assistant professor, supervisor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilition Faculity of Tabriz University of Medical Sciences, Next to Vahdat Hall, Tabriz University, 29 Bahman Blvd, Tabriz City
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3384 5381
Fax
Email
amirshakerib@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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