study aim was how tension type headache was improved by METS and myofascial release
Design
A single blinded randomized control trial with sample size of 48 patients
Settings and conduct
setting of study was in Rehabilitation and Injury Management Department of Medcare International Hospital Gujranwala
Participants/Inclusion and exclusion criteria
Patients of both gender of age 18-40 years with diagnosis of tension type headache and chronic tension type headache were included. Other inclusion criteria regarding tension type headache were at least 10 episodes occurring on ≥1 day per month for at least 3 months. Headache episodes lasting from 30 minutes to 7 days
Intervention groups
Muscle energy technique along with myofascial release technique on upper trapezius and sternocleidomastoid was applied on patients of experimental group . Only myofascial release technique was used on upper trapezius and sternocleidomastoid muscle to control group
Main outcome variables
Outcome variables of pain, range of motion and functional level of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190121042445N2
Registration date:2021-02-07, 1399/11/19
Registration timing:prospective
Last update:2021-02-07, 1399/11/19
Update count:0
Registration date
2021-02-07, 1399/11/19
Registrant information
Name
Muhammad Akhtar
Name of organization / entity
University of Lahore,Lahore, Pakistan
Country
Pakistan
Phone
+92 55 3732032
Email address
a.hunjra@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2640-09-23, 2019/07/01
Expected recruitment end date
2641-03-22, 2020/01/02
Actual recruitment start date
2640-09-23, 2019/07/01
Actual recruitment end date
2641-03-22, 2020/01/02
Trial completion date
2641-03-22, 2020/01/02
Scientific title
Effects of muscle energy technique in patients with tension type headache on pain , range of motion and functional level
Public title
Effects of muscle energy technique in patients with tension type headache on pain , range of motion and functional level
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of both gender of age 18-40 years with diagnosis of ETTH and CTTH were included
At least 10 episodes occurring on ≥1 day per month for at least 3 months
Headache episodes lasting from 30 minutes to 7 days
Exclusion criteria:
Patients with Headache that is aggravated by head movements, musculoskeletal and metabolic disorders with symptoms homogenous to headache (rheumatoid arthritis), previous neck trauma, Vertigo, dizziness, arterial hypertension, Malignancy, infection, trauma, bone deformities were excluded from the study.
Age
From 18 years old to 48 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were selected through Non probability convenient sampling technique as per inclusion and exclusion criteria. Patients of TTH were randomly allocated into 2 equal groups (Group A=24 and Group B=24) and randomization was done by lottery method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A prospective randomized clinical trial study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medcare International Hospital
Street address
Nil
City
Gujranwala
Postal code
52250
Approval date
2640-09-22, 2019/06/31
Ethics committee reference number
329
Health conditions studied
1
Description of health condition studied
Tension type headache
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
baseline, 4th and 8th weeks since intervention
Method of measurement
Numerical pain Rating scale (NPRS)
2
Description
range of motion
Timepoint
baseline, 4th and 8th weeks since intervention
Method of measurement
Inclinometer is used to assess cervical range of motion.
3
Description
functional level
Timepoint
baseline, 4th and 8th weeks since intervention
Method of measurement
Headache disability index and headache impact test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group; Muscle Energy Technique on upper trapezius The patient places in a moderate opposed exertion (20% of the accessible solidarity) to convey the decent shoulder to the ear (a shrug movement) and the ear to the shoulder. There ought to be a moderate level of duty and no uneasiness ought to be experienced. The compression goes on for 7-10 seconds and when the exertion is totally loose. Muscle energy technique on sternocleidomastoid Patient is approached to lift a little degree to the roof the completely turned head and to hold the breath. There is no requirement for the professional to apply opposition when the head is raised as this is adequately given by gravity. Between 7-1 0 seconds of isometric constriction, the patient is advised to discharge the exertion (and breath) bit by bit and position the head on the table so that there is a little level of expansion. Moist heating pad is applied for 10 minutes before each session. Protocol 2: Myofascial release technique on upper trapezius The muscle is put on a gentle leeway by moving the ear somewhat to the shoulder on a similar side with the patient recumbent, or presumably sitting. The whole mass of the upper trapezius is raised off the supraspinatus muscle and summit in a pincer grasp. The muscle at that point rolls firmly between the fingers and thumb to palpate for a knob and tight groups to discover Trigger point's spot delicacy. Treatment session longs for 10 minutes of myofascial release on each side. Myofascial release technique on sternocleidomastoid The patient sits in a low-upheld firm-sitting easy chair easily and loose with each hand's fingers snared under the seat or under the thigh. The patient's head might be supported in the administrator's hand to enable the patient to loosen up the neck muscles, with the administrator's head leaning against the administrator's arm or chest. The patient is encouraged to rest the administrator's head weight and utilize greatest profound stomach breathing, which likewise unwinds. Therapist applies pressure on trigger points located in sternal and clavicular divisions of muscle with pincer grip. Gradually increasing the pressure and releasing the trigger points one by one. This is followed by stretching of muscle by deep inhalation, rotation of head on opposite side and rotation of chin on same side. Treatment session longs for 10 minutes of myofascial release on each side.
Category
Treatment - Other
2
Description
Control group: Treatment applied in this group is myofascial release technique for upper trapezius and sternocleidomastoid muscle. This was applied in the same way mentioned in the protocol 2 of intervention no. 1.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Medcare Internationl Hospital
Full name of responsible person
Dr Akhtar
Street address
Gill Road
City
Gujranwala
Postal code
52200
Phone
+92 55 3732032
Email
a.hunjra@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medcare International Hospital
Full name of responsible person
Dr Akhtar Hunjra
Street address
Gill Road
City
Gujranwala
Postal code
52200
Phone
+92 55 3732032
Email
a.hunjra@gmail.com
Grant name
N/A
Grant code / Reference number
N/A
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medcare International Hospital
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Medcare International Hospital
Full name of responsible person
Dr Akhtar
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
gujranwala
City
Gujranwala
Province
Punjab
Postal code
52200
Phone
+92 55 3732032
Email
a.hunjra@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medcare International Hospital
Full name of responsible person
Dr Akhtar
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Gill Road
City
Gujranwala
Province
Punjab
Postal code
52200
Phone
+92 55 3732032
Email
a.hunjra@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Medcare International Hospital
Full name of responsible person
Dr Akhtar
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Gill road
City
Gujranwala
Province
Punjab
Postal code
52200
Phone
+92 55 3732032
Email
a.hunjra@gmail.com
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
Individual participant data will not be shared to others as it is my personal property
Study Protocol
Yes - There is 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
Title and more details about the data/document
Effects of muscle energy technique in patients with tension type headache on pain , range of motion and functional level
1)Study protocol will be shared on request through email.
2) All collected deidentified IPD and IPD collected for the primary outcome measures will be shared on request through email.
When the data will become available and for how long
After publication of my articles
To whom data/document is available
For academic institutions and Hospitals use
Under which criteria data/document could be used
The person who will request for data. All types of analysis will be shares through email on request
From where data/document is obtainable
data can be obtained through email to Dr. Akhtar Hunjra
What processes are involved for a request to access data/document
Through email or phone call request data can be available