1. Home
  2. Approved trials
  3. » فارسی

The effects of myofascial trigger points release of longus colli muscle on pain and range of motion in patients with neck pain

Protocol summary

Study aim
Investigation of the immediate effect of releasing trigger points of the longus colli muscle and placebo ultrasound on pain, range of motion of neck pain joints in people with non-specific neck pain
Design
A clinical trial with the control group, parallel groups, randomized, phase 2 on 50 patients. The rand function of Excel software was used for randomization.
Settings and conduct
This research project will be carried out by a physiotherapist in the physiotherapy clinic of the comprehensive center and, if possible, in the private physiotherapy center. For this purpose, after the patients visit the above clinic, a list of people who meet the inclusion criteria will be prepared, and the studied people will be interviewed. People who meet the study entry criteria will be selected non-randomly. After filling out the consent form, they will be randomly assigned (sealed envelope) to two groups, including 1) the trigger point release group of longus colli muscle and 2) the control group receiving placebo treatment. Randomization is done in a blocked manner.
Participants/Inclusion and exclusion criteria
Chronic neck patients over the age of 18 who do not have a history of particular diseases and red-flag symptoms.
Intervention groups
In this study, the myofascial release technique of the longus colli muscle is performed manually while the patient is lying on her back.
Main outcome variables
pain and range of motion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230212057390N2
Registration date: 2023-10-07, 1402/07/15
Registration timing: prospective

Last update: 2023-10-07, 1402/07/15
Update count: 0
Registration date
2023-10-07, 1402/07/15
Registrant information
Name
Majid Shahbazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6710
Email address
shahbazim2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of myofascial trigger points release of longus colli muscle on pain and range of motion in patients with neck pain
Public title
The myofascial trigger points release of longus colli muscle in neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient shows at least mild disability, number 5-14, based on the Neck Disability Index (NDI) scale. Complaints of chronic neck pain (more than 3 months) When entering the study, patients should have at least 3 pain based on the VAS scale when performing neck movements. Patients have not used painkillers 24 hours before the tests. Being over 18 years old
Exclusion criteria:
Observation of any serious pathology such as specific neck pain and red flag symptoms such as cervical spine tumor, whiplash injury, neck fracture, and previous cervical spine surgery were excluded from the study. Patients with a recent cerebrovascular stroke, myocardial infarction, chronic lung or kidney disease, serious medical or psychiatric conditions, or unstable dementia were also excluded. Patients who do not want to participate in the study for any reason.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated in the experiment, half assigned to the control group (n = 25) and half to the experimental group (n = 25) using the block randomization method. The randomization was performed by an investigator who was not involved with participant intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Approval date
2023-03-04, 1401/12/13
Ethics committee reference number
IR.MUMS.FHMPM.REC.1401.203

Health conditions studied

1

Description of health condition studied
neck pain
ICD-10 code
S16
ICD-10 code description
Injury of muscle, fascia and tendon at neck level

Primary outcomes

1

Description
Measurement of pain and range of motion
Timepoint
After the patient referred to the physical therapy center
Method of measurement
Pain is measured with a visual analog scale (VAS) and range of motion with a goniometer.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The method of performing the myofascial release technique: For manual muscle release, while the patient is lying on his back, the head is slightly extended to provide sufficient access to the anterior region of the neck. The back of the index, middle, and ring fingers are placed under the sternocleidomastoid muscle and gently lifted. In contrast, the pads of the fingers are placed on the anterior surface of the transverse processes. Then, the fingers go back and towards the anterior cervical spine. It slides and sits directly on it. The longus colli muscle at that point is covered only by subcutaneous tissue and skin. In this case, the back of the fingers is placed in front of the trachea, and the tips of the fingers are placed under the carotid and sternocleidomastoid sheaths. Then, the manual release is done with a deep massage of the longus colli muscle. The release includes gentle massage of the muscle in a cranial-caudal way. The fingers are gently moved over the anterior surface of the cervical seals and transverse processes while the patient performs mild flexion-extension movements of the neck [9]. Another method of touching the trigger points in the longus colli muscle can be felt by placing the examining finger along the lateral border of the trachea between the sternocleidomastoid muscle and the thyroid cartilage, and by separating the muscle from the adjacent trachea, gently rocking it forward. When the finger hits the vertebral column, the area is examined for trigger points by cross-fiber palpation [8].
Category
Rehabilitation

2

Description
Control group: Conducting ultrasound of the anterior neck region. The subject is informed that pulsed ultrasound will be used. They should not feel any heat or pain. Since this is a dummy method, such an adjustment will not make any real difference. Ultrasound lotion is applied on the front of the neck between the sternocleidomastoid muscle and trachea, and the ultrasound head is moved slowly on the front of the neck in the area of trigger points for 2 minutes. The device's timer will alert the therapist when 2 minutes have passed.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy clinic of the Comprehensive Center of Mashhad University of Medical Sciences and, if p
Full name of responsible person
Majid Shahbazi
Street address
Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
shahbazim2@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Shahbazi
Street address
Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
shahbazim2@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Majid Shahbazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
shahbazim2@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Shahbazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
shahbazim2@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid shahbazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physical Therapy, School of Paramedical and Rehabilitation Sciences, University campus, Azadi square, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Email
shahbazim2@mums.ac.ir

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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as the information related to the main outcome, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
It will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Access is possible after a written request to Mashhad University of Medical Sciences and after examination.
From where data/document is obtainable
Dr. Majid Shahbazi - Mashhad University of Sciences - Faculty of Paramedical Sciences - Department of Physiotherapy - 09155228949
What processes are involved for a request to access data/document
Send a written request to the Department of Physiotherapy of the University of Medical Sciences and an answer will be given after review. It will take about 1 month.
Comments
Loading...