Determining the effect of massage therapy on pain intensity, number of attacks and frequency of analgesic use in patients with migraine referred to the office of internal neurologists in Bandar Abbas in 2021
Design
This study consists of three groups of touch massage and control of 20 people.
Settings and conduct
The massage will be performed by a trained family member at the patient's home. The patient lies on a mattress that feels comfortable. Massage the trapezius and neck muscles and the occipitofrontal, vascalp and frontal muscles with moderate pressure in the massage group and without pressure in the touch group. The control group is monitored without any intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Confirmation of the diagnosis of migraine by a neurologist using the International Index to diagnose headache for at least one year
Headaches occur at least four times a month (once a week)
Age over 18 years
Written consent to participate in the study
Exclusion criteria:
neurological disorders and other severe physical diseases and chronic systemic diseases
addiction to drugs and alcohol
Absence of wounds, thrombosis, hematoma, malignancy and skin changes and abnormalities in the head and neck areas that prevent massage
take anticoagulants
cardiovascular disease
pregnancy and lactation
Intervention groups
In the massage therapy group, the method of massage will be taught by one of the researchers who has received the certification of the training course on massage therapy protocol, to a member of the patient's family who is introduced by the patient and the person volunteers to receive training and massage.
For the touch group, only touch without pressure will be performed with the same duration and location as the massage therapy group
Main outcome variables
Pain intensity - number of attacks and frequency of painkillers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201116049403N1
Registration date:2021-03-12, 1399/12/22
Registration timing:retrospective
Last update:2021-03-12, 1399/12/22
Update count:0
Registration date
2021-03-12, 1399/12/22
Registrant information
Name
zakieh faghihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 1010
Email address
faghihi_2020@ yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigation the effect of neck and head massage on the intensity of pain, frequency of attacks and analgesic usage in patients with migraine
Public title
investigation the effect of neck and head massage on the intensity of pain, frequency of attacks and analgesic usage in patients with migraine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of the diagnosis of migraine by a neurologist using the International Index to diagnose headache for at least one year
Headaches occur at least four times a month (once a week)
Age over 18 years
Written consent to participate in the study
Exclusion criteria:
neurological disorders and other severe physical diseases and chronic systemic diseases
addiction to drugs and alcohol
Absence of wounds, thrombosis, hematoma, malignancy and skin changes and abnormalities in the head and neck areas that prevent massage
take anticoagulants
cardiovascular disease
pregnancy and lactation
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be assigned to the three groups of massage therapy, control and touch by randomization method based on sex classes (male and female) and duration of infection (5 years and less - more than 5 years). The entry of the first sample in the table is based on a lottery. For example, a man with a history of more than 5 years will be placed in the massage group by drawing lots between the three groups, the next people like him will be assigned to the touch and control group, respectively, and the rest will be a man with a history of less than 5 years. A woman with a history of more than 5 years and a woman with a history of less than five years will be performed in the same way to reach the quorum.
Blinding (investigator's opinion)
Double blinded
Blinding description
n this study, participants in the non-pressure touch group are unaware of the placebo of this method. Also, the clinical caregiver of the touch group is unaware of the placebo of this study during the study. Data analyzer of which Reforms are not known to which group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of rafsangan University of Medical Sciences
Street address
West daneshvar
City
Bandar Abbas
Province
Hormozgan
Postal code
7919748306
Approval date
2020-10-03, 1399/07/12
Ethics committee reference number
IR.RUMS.REC.1399.176
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain score in Visual Analogue Scale and Headache Impact Test-6 (HIT-6)
Timepoint
Measurement of headache severity one month before the intervention, one month during the intervention and one month after the intervention
Number of migraine attacks in one month before the intervention and one month during the intervention and one month after the intervention
Method of measurement
frequency of analgesic use
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: massage group;In the massage therapy group, the method of massage will be taught by one of the researchers who has received the certification of the training course on massage therapy protocol, to a member of the patient's family who is introduced by the patient and the person volunteers to receive training and massage. After the training, the massage protocol will be repeated on the patient by the family member in the presence of the researcher to ensure accurate and complete learning.The massage will be performed by a trained family member of the patient. The intervention will be performed in a quiet, private, clean and hygienic room, safe, without noise and without disturbing the movement of others, with proper air conditioning and with the protection of the patient's privacy. The patient will wear disposable comfortable clothing so that his shoulders and neck are available for massage. The patient lies on a mattress that feels comfortable and the therapist is placed on top of the patient. The therapist also needs to wear comfortable and soft clothes to be able to perform massage movements gently and gently. Before starting the massage, the hands should be warm, and if the hands are cold, they should be gently warmed by rubbing the palms on top of each other. Baby oil is turquoise, it will be used for massage.Trapezius muscle massage: The massager is placed on top of the patient and the patient in the prone position and we use the skin roll technique (3 minutes), muscle roll (3 minutes) and needling (3 minutes). In the skin roll method, we use lifting the skin with the thumb by starting from the midline of the spine and continuing to the lateral end of the rotation of the scapula under the armpits on both sides, and from the shoulders from near the scapula to the base of the neck We continue. Muscle roll technique, which is done by applying pressure with the length of sixty fingers from the midline of the spine to the periphery at the site of the trapezius muscle, and the technique of needling, which is performed by direct pressure of the thumb on the sacrospinalis on both sides of the patient. Neck massage: To massage the neck, we use the prone position (2 minutes) and the needling technique, and with the fingers of both hands, we continue the massage from the back of the occiput to the area where the neck extends and below the scapular area. . In the lateral part of the neck (2 minutes) we use all the fingers and continue the protrusion of the trapezius. The palm while the fingers are in front of the upper fiber of the trapezius, we start kneading with pressure, then the patient in the lateral position (2 minutes) and then supine (2 minutes) and massage with your fingertips the muscles of the upper trapezius that is attached to the neck in the same way. Massage of the occipital frontal muscle: To massage the occipital frontal muscle of the patient in the supine position, we use the muscle stitching technique (2 minutes) by placing the palm of one hand on the forehead and the palm of the other hand under the sub-occipital muscle. We place the forehead and move it downwards or towards the eyebrows and the hand under the head upwards at the same time so that it feels like the scalp is moving forward and backward. Scalp massage: To perform this massage, three techniques of floristry (2 minutes), needling (2 minutes) and vibration (2 minutes) are used. In the flossing technique, the therapist places the fingers of both hands on both sides of the temporal area and the patient's scalp. Gently massage in a circular motion. In the needle massage technique, massage is performed on the whole skull, in the occipital frontal area and above the afferent massage area by the movements of all fingers. The vibration technique is common with the location of the needle method, so that the palms of both hands are on the area. Massage is performed and gentle reciprocating movements are performed in the form of vibration.Frontal area massage: Needing technique (2 minutes) and afferage (2 minutes) are used. In needling method, it is done using two, three or four fingers by massaging the midline of the forehead in the frontal and temporal directions. All fingers are used and the midline is drawn around and down in a curve (21). And 1 minute is spent rotating the patient. It should be noted that massage maneuvers will be performed with moderate pressure. The therapist made sure that his nails were not long and that he did not have a ring or ring in his hand so as not to damage the patient's skin. , Be comfortable and warm. All stages of massage in one step are taught in person with the patient and in the presence of the patient. Also a copy of the massage training video, to prevent possible forgetfulness. It is provided to the patient.The duration of the intervention will be 4 weeks, twice a week with a minimum interval of 48 hours between each session and each session will be performed for 30 minutes.
Category
Rehabilitation
2
Description
second intervention group: Touching the neck and neck exactly according to the massage method without applying pressure
Category
N/A
3
Description
Control: No intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of the Holy Prophet Research and Therapeutic Center
Full name of responsible person
Zakia Faqihi
Street address
Islamic Republic of Iran Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7000
Fax
Email
shmh@hums.ac.ir
Web page address
https://shmh.hums.ac.ir/
2
Recruitment center
Name of recruitment center
Private office of Dr. Elham Ospid, neurologist
Full name of responsible person
Zakia Faqihi
Street address
no 12 ,Sharif Building ., Seyed Jamaluddin Asadabadi Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7914715152
Phone
+98 76 3221 3099
Email
elyouspid@gmail.com
Web page address
http://trtv.hums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Shamsizadeh
Street address
Central Organization, Imam Ali Boulevard, Rafsanjan,
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Fax
+98 34 3428 0071
Email
info@rums.ac.ir
Web page address
http://www.rums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?