Protocol summary

Study aim
Determining the effect of Yo Mi Ho therapy massage on pain, proprioception, back and shoulder range of motion in men with trigger point back pain.
Design
This research will have an intervention group and a control group, without blinding, randomized, on 30 people. Randomization will be done using the ball and box method without replacement.
Settings and conduct
The research is in the form of a pre-test and post-test design, semi-experimental and applied. The study will be conducted on men with back pain caused by trigger points in Isfahan city, Isfahan province.
Participants/Inclusion and exclusion criteria
The presence of a hidden trigger point in the back area. Male gender
Intervention groups
A total of 15 people will have a Yo Mi Ho therapy program for 6 weeks (3 sessions per week and 30 minutes each session), which will be applied to the back area and trigger points. Yu Mi Ho massage is a combination of massage, pressure, rubbing and opening or stretching of the connective tissue, which will be done by hand movements on specific points. During this period, massage is not applied to the control group. After the end of the course, the pain level and range of motion will be evaluated again in the groups.
Main outcome variables
Knowledge of the effect of Yo Mi Ho therapy massage on pain, proprioception, back and shoulder range of motion in men with trigger point back pain.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220830055832N1
Registration date: 2022-09-19, 1401/06/28
Registration timing: prospective

Last update: 2022-09-19, 1401/06/28
Update count: 0
Registration date
2022-09-19, 1401/06/28
Registrant information
Name
Reza Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3665 0771
Email address
reza.samadi@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-24, 1401/07/02
Expected recruitment end date
2022-11-03, 1401/08/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Yu Mi Ho therapy massage on pain, proprioception, range of motion of the back and shoulders in men with back pain caused by trigger point
Public title
The effect of Yu Mi Ho therapy massage on men with back pain caused by trigger points.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of a hidden trigger point in the back areaTranslate. Male gender
Exclusion criteria:
Manifestation of the trigger point in the back area The presence of pain that prevents massage The presence of damage in the shoulder joint Neuralgic injuries of the back area
Age
From 20 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the limited randomization method for all study groups with equal sample size, and among the types of limited randomization methods, we will use the assigned law randomization to achieve a balance in the number of people assigned to the study groups. . First, we write the names of 30 people from the samples on the ball and put them in the box. We remove the balls from the box at random and without replacement. The 15 balls that we took out of the box at the beginning are called the intervention group and the 15 balls that are left are called the control group. Since it is not possible to reveal the random sequencing and to know the next assignment, concealment will not be performed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Isfahan Azad University (Khorasgan)
Street address
University Blvd, Arghvanieh, East J St., Esfahan
City
Esfahan
Province
Isfehan
Postal code
815513999813
Approval date
2022-05-30, 1401/03/09
Ethics committee reference number
IR.IAU.KHUISF.REC.1401.089

Health conditions studied

1

Description of health condition studied
trigger point
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Back pain
Timepoint
The beginning of the study (before the intervention) and 6 weeks after that.
Method of measurement
A pain ruler will be used to determine the amount of back pain when pressing the trigger point. It is like a line 100 mm long, where the number zero indicates the absence of pain and the number 10 indicates the maximum amount of pain. According to the amount of pain they have had in the past 24 hours, the subjects draw a line around the stickers that are on the ruler and express the intensity of the pain, then by measuring the desired point, the intensity of the pain is measured in millimeters. . Numbers in the range of 0-10 mm indicate no pain, 10-30 mm indicate mild pain, 40-60 mm indicate moderate pain, and 70-100 mm indicate severe pain.

2

Description
Dorsiflexion range of motion
Timepoint
The beginning of the study (before the intervention) and 6 weeks after that.
Method of measurement
Schuber's test will be used to evaluate the dorsiflexion range of motion. First, the shock appendage of the seventh cervical vertebra is marked, and then the shock appendage of the last dorsal vertebra is identified and this distance is measured with a tape measure. Then, the person will be asked to do spinal flexion and this distance will be measured again. In this case, the distance obtained in the standing position will be subtracted and the final measurement will be recorded.

3

Description
Internal rotation range of motion
Timepoint
The beginning of the study (before the intervention) and 6 weeks after that.
Method of measurement
In this measurement, the patient is placed lying on his back. The hand whose range of internal rotation should be measured is placed in the position of 90 degrees of shoulder abduction and 90 degrees of elbow flexion. To neutralize the arm and prevent extra movements in the shoulder joint, a folded towel is placed under the person's arm and the lower part of the arm is kept steady. Layton's flexometer is tightly and closed to the outer middle part of the forearm and one of its plates is locked. The arm on the opposite side is also placed freely next to the body. In this case, the person's forearm actively moves down as far as possible, and at the end of the range of motion, the other Eton indicator is locked. The obtained size is recorded.

4

Description
External rotation range of motion
Timepoint
The beginning of the study (before the intervention) and 6 weeks after that.
Method of measurement
In this measurement, the patient is lying on his back. The hand whose range of external rotation should be measured is placed in a position of 90 degrees of shoulder abduction and 90 degrees of elbow flexion. To neutralize the position of the arm and prevent excess movements in the shoulder joint, a folded towel is placed under the person's arm and the lower part of the arm is kept steady. Layton's flexometer is tightly tied to the middle outer part of the forearm and we lock one of its plates. The arm on the opposite side is also placed freely next to the body. In this case, the person's forearm actively moves up and back as far as possible and is locked at the end of the range of motion of the other Leighton indicator. The obtained size is recorded in a special data measurement form.

5

Description
Deep feelings
Timepoint
The beginning of the study (before the intervention) and 6 weeks after that.
Method of measurement
50% of the range of motion of the internal rotation of the shoulder was considered as the target angle in the reconstruction of the angle for the evaluation of depth perception. In the next step, for the test of active angle reconstruction, the target organ was taken to the target angle by the patient with open eyes and with the guidance of the examiner, and while it was held for 5 to 10 seconds; The patient was asked to memorize the angle and this process was repeated three times. Then the patient was asked to slowly move the limb to the desired angle. The active angle reconstruction test was repeated three times and the average error of three times of angle reconstruction was recorded under the title of absolute reconstruction error, which will be evaluated with a goniometer.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Yo Mi Ho therapy program will be applied to the back area and trigger points for 6 weeks (3 sessions per week and each session lasts 30 minutes).
Category
Rehabilitation

2

Description
Control group: The control group will continue their normal life during this period.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Pardis specialized health institute.
Full name of responsible person
Somayeh Baharlu
Street address
No. 32, after the alley of 16, Arbab St.
City
Esfahan
Province
Isfehan
Postal code
8165765611
Phone
+98 31 3665 9771
Email
Rezasamadiii1373@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Taghiani
Street address
University Blvd, Arghvanieh, East J St., Esfahan.
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
toghiani@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Reza Samadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Sports pathology and corrective movements
Street address
University Blvd, Arghvanieh, East J St., Esfahan
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 5353 4001
Email
Rezasamadiii1373@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reza Samadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Sports pathology and corrective movements.
Street address
University Blvd, Arghvanieh, East J St., Esfahan
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 5353 4001
Email
Rezasamadiii1373@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reza Samadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Sports pathology and corrective movements
Street address
University Blvd, Arghvanieh, East J St., Esfahan
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 5353 4001
Email
Rezasamadiii1373@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
All data related to people who participate as a sample in this research will be shared after de-identification.
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
The documents of this research are available to researchers working in academic institutions, physiotherapists and physical medicine specialists.
Under which criteria data/document could be used
In order to prevent harm, in the centers where there are people with the problem mentioned in the research.
From where data/document is obtainable
Reza Samadi Phone: 00989013105153 Email: Rezasamadiii1373@gmail.com
What processes are involved for a request to access data/document
Checking the application, checking the applicant's documents, sending the required documents
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