Effects of positional release and passive shortening techniques on pain and muscle thickness in people with latent trigger points
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, on 42 patients. Random allocation software was used for randomization.
Settings and conduct
Participants in the study are divided into two groups of intervention and control using a computer randomization program. The study is conducted blindly and the evaluator does not know what group each person belongs to. Everyone attends three sessions a week and is re-evaluated one week after the third session. Evaluation of the effects of treatment using VAS and muscle thickness is performed by another physiotherapist.
Participants/Inclusion and exclusion criteria
The presence of a latent trigger point in the right or left upper trapezius muscle (if both sides are involved, the selection will be random)
Having a minimum pain of 3 and a maximum of 7 on the visual scale of pain during the application of force 2.5 kg / cm2 by the algometer
Intervention groups
Control group: People for whom PRT technique is performed.
Intervention group: People for whom MPMS technique is performed.
Main outcome variables
thickness of the upper trapezius muscle
pain of the upper trapezius muscle
pain pressure threshold of the upper trapezius muscle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151007024412N5
Registration date:2022-11-27, 1401/09/06
Registration timing:prospective
Last update:2022-11-27, 1401/09/06
Update count:0
Registration date
2022-11-27, 1401/09/06
Registrant information
Name
Sakineh Goljaryan
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5921
Email address
goljaryan@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-01, 1401/09/10
Expected recruitment end date
2023-03-01, 1401/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of positional release and passive shortening techniques on pain and muscle thickness in people with latent trigger points
Public title
Thickness changes in myofascial pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age 18 and maximum 35
The presence of a latent trigger point in the right or left upper trapezius muscle (if both sides are involved, the selection will be random)
Having a minimum pain of 3 and a maximum of 7 on the visual scale of pain during the application of force 2.5 kg / cm2 by the algometer
BMI between 20-25
Being a non-athlete
Exclusion criteria:
Having a history of radiculopathy or myelopathy of the neck with the diagnosis of a specialist
Fibromyalgia syndrome diagnosed by a specialist doctor
History of neck and shoulder surgery during the past year
Trigger point treatment in the last month
Existence of sensory disturbance in trapezoidal area
Having a history of Whiplash injury
Acute upper trapezius muscle injury in the last 6 days
Age
From 18 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
42
More than 1 sample in each individual
Number of samples in each individual:
21
21 people in the control group and 21 people in the intervention group
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed by someone outside the research team using the 1: 1 parallel allocation method. A computer randomization program is used to assign participants to groups, using blocks of four and six. Matte sealed envelopes are then used and concealment is done by assigning groups using the pre-labeled letters A and B.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will done in a blind way and the evaluator does not know which group each person is in. First, preliminary evaluations including muscle thickness, PPT and VAS are performed by the examiner. After the evaluations are completed, therapeutic techniques are applied based on the group that each person is randomly placed in, by another person (therapist) and without the knowledge of the evaluating person (examiner). Immediately after the completion of the technique, the evaluations will be done again by the examiner.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
29 Bahman street - Tabriz University - Faculty of Rehabilitation Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2022-08-29, 1401/06/07
Ethics committee reference number
IR.TBZMED.REC.1401.486
Health conditions studied
1
Description of health condition studied
Myofascial pain syndrome
ICD-10 code
M62.9
ICD-10 code description
Disorder of muscle, unspecified
Primary outcomes
1
Description
thickness of the upper trapezius muscle
Timepoint
Before the start of the intervention, immediately after the intervention, 2 days after the first session, 9 days after the first session
Method of measurement
sonography
2
Description
Pain
Timepoint
Before the start of the intervention, immediately after the intervention, 2 days after the first session, 9 days after the first session
Method of measurement
Visual Analogue Scale
3
Description
pain pressure threshold
Timepoint
Before the start of the intervention, immediately after the intervention, 2 days after the first session, 9 days after the first session
Method of measurement
pressure algometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Manual Passive Muscle Shortening technique: The person sleeps on his back and a pillow is placed under his abdomen. The therapist stands on the involved side and brings the beginning and end of the involved upper trapezius muscle (the periphery of the sixth cervical vertebra and the acromion appendage) closer together using the web of his hands and shortens the muscle. This position is maintained for 90 seconds and finally the muscle is slowly released and returns to its original position. These steps are repeated three times.
Category
Treatment - Other
2
Description
Control group: Positional release. The patient sleeps on the vault and the therapist stands on the involved side. Then with his finger, he applies some pressure on the trigger point that has the most pain (A) and asks the person to keep in mind the amount of pain caused by this pressure. The person's head bends towards the trigger point. Then the therapist takes the person's hand and takes the person's shoulder to about 90 degrees of abduction and slowly moves the hand in different planes in search of the ideal position. After finding the ideal position (minimum 70% reduction of pain at the desired point), while the therapist's finger is placed on the painful point without pressure, the person's hand and shoulder are kept in that position for 90 seconds. Finally, the person's body is passively returned to its original state and these steps are repeated three times.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Goljaryan
Street address
29 Bahman
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 5359
Fax
+98 41 3337 5359
Email
goljaryan@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
29 Bahman street. Tabriz University
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 5359
Email
goljaryan@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
Sakineh Goljaryan
Position
assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University. Faculty of Rehabilitation Sciences.29 Bahman Street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 5359
Fax
+98 41 3337 5359
Email
goljaryan@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Goljaryan
Position
Staff member
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences, Golgasht Street, University Street, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Fax
+98 41 3335 9680
Email
goljaryan@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Goljaryan
Position
Staff member
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences, Golgasht Street, University Street, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Fax
+98 41 3335 9680
Email
goljaryan@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
Although the data is non-identifying of the participants, only the statistical results obtained from the data are published, and they are not published in order to prevent other people from copying and creating data.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All statistical results from the data are published in congresses and articles.
When the data will become available and for how long
After completing the study and printing the results
To whom data/document is available
The general public and researchers and academics
Under which criteria data/document could be used
It is allowed by experts and for use in treatment.
From where data/document is obtainable
Journals in which the results have been published. Project manager:
Dr. Sakineh Goljaryan.
What processes are involved for a request to access data/document