The effect of Sohrman's approach on headache and balance indicators of patients with chronic cervicogenic headache
Design
Randomized, single blinded clinical trial on 32 patients with cervicogenic headache. Permutation blocks will be used for randomization. the patients randomly divided into two groups of Sohrmans exercises and routine physiotherapy group.
Settings and conduct
Razmjo Moghadam Physiotherapy Clinic Zahedan
The physiotherapist evaluating the patients is blind to the treatment performed
Participants/Inclusion and exclusion criteria
Patients with cervicogenic headache aged 18 to 65 years who have neck extension and rotation extension syndrome based on Sohrman criteria.
; suffering from malignancies, severe pastural disorders, progressive diseases
Intervention groups
The participants in the routine treatment group will be treated with hot packs, TENS with a frequency of 100 Hz and diversion of 50 microseconds, and ultrasound with a frequency of 1 megahertz and an intensity of 1 w/cm2 in the paravertebral areas and trapezius muscles.The duration of each session will be 30 minutes.In the Sohrman exercise group, in addition to receiving TENS, hot pack and ultrasound (under the same conditions as in the routine treatment group), the patient will be taught functional exercises and training during daily activities to improve movement. Each exercise will be repeated in 3 series and each series 10 times. According to the diagnosis of the type of movement syndrome and including rest time, exercises will be performed for 35 to 50 minutes in each session. The number of treatment sessions will be 12 sessions, three days a week for four weeks. All exercises will be done in each session under the supervision of a physiotherapist.
The effect of sahrman approach on headache and balance indices in patients with chronic cervicogenic headache: single blinded randomize clinical trial
Public title
The effect of sahrman exercise on headache and balance in patients with cervical headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women between the ages of 18-65
Having a history of headache for at least three months
Having at least 5 of the CHISG diagnostic criteria.
Having most (more than half) of Sohrman's diagnostic criteria for extension and extension rotation syndrome.
Absence of: degenerative symptoms, radiculopathy, severe pastural disorders, progressive rheumatological and neurological diseases, history of accidents and whiplash injuries, malignancy.
No history of neck surgery and no blood pressure disorders, vision problems, and dizziness
Exclusion criteria:
disinclination to continue treatment
Aggravation of symptoms during treatment
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Considering that age, gender, obesity and thinness can be confounding variables based on past studies, it is necessary to match the two control and intervention groups with respect to these variables. Based on gender, age (less than or equal to 40 and more than 40 years) and obesity (thin, normal, overweight and obese) will be placed in an age-sex-obesity subgroup. Then in each subgroup of a random sequence that The permutation block method based on the table of random numbers will be used to place people in one of the control or intervention groups. The size of each block will be considered 2.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcomes is assessed by another physiotherapist who is blind to the type of treatment being given to the patient
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2022-07-24, 1401/05/02
Ethics committee reference number
IR.ZAUMS.REC.1401.165
Health conditions studied
1
Description of health condition studied
cervicogenic headache
ICD-10 code
G44
ICD-10 code description
Other headache syndromes
Primary outcomes
1
Description
balance
Timepoint
Before and after treatment and one month after treatment
Method of measurement
Biodex SD device
2
Description
Headache intensity
Timepoint
Before and after treatment and one month after treatment
Method of measurement
visual analog scale
Secondary outcomes
1
Description
Headache disability
Timepoint
Before and after treatment and one month after treatment
Method of measurement
Headache Disability Questionnaire
2
Description
neck disability
Timepoint
Before and after treatment and one month after treatment
Method of measurement
Neck disability index
3
Description
Duration of headache
Timepoint
Before and after treatment and one month after treatment
Method of measurement
questionnaire
4
Description
frequency of headache
Timepoint
Before and after treatment and one month after treatment
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Sohrman's exercises:In the Sohrman exercise group, in addition to receiving TENS, hot packs and ultrasound(under the same conditions as in the routine treatment group), the patient will be taught exercises and functional training during daily activities to improve movement. Each exercise is repeated in 3 series and each series 10 times. According to the type of movement syndrome and including rest time, exercises will be done for 35 to 50 minutes in each session. The number of treatment sessions will be 12 sessions, three days a week for four weeks.
Category
Rehabilitation
2
Description
Participants in the routine treatment group will be treated with hot packs, TENS with a frequency of 100 Hz and 50 microseconds duration, and ultrasound with a frequency of 1 megahertz and an intensity of 1 w/cm2. The electrodes will be placed in the occipital and paravertebral areas on both sides, and the intensity of the current used for each patient will be adjusted to the level of pain-free paresthesia. Ultrasound will be applied in the areas of the paravertebral muscles and the upper and outer edge of the upper trapezius muscle, unilaterally and for 5 minutes. The duration of each session will be 30 minutes
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Razmjo Moghadam Physiotherapy Clinic
Full name of responsible person
Dr. Mohammad Hosseinifar
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo Moghadam Laboratory, Ayatoallah Kafami St.
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
6485598136
Phone
+98 54 3321 7006
Email
fardash_s@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Noor Mohammad Bakhshani
Street address
Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq.
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
6458898136
Phone
+98 54 3329 5796
Email
nmbakhsha@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hosseinifar
Position
PhD in Physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy, Faculty of Rehabilitation Sciences, Razmojomoghadam Laboratory, Ayatollah Kafami St.
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
6485598136
Phone
+98 54 3342 4675
Email
fardash_s@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hosseinifar
Position
PhD in Physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy, Faculty of Rehabilitation Sciences, Razmjomoghadam Laboratory, Ayatollah Kafami St.
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
6485598136
Phone
+98 54 3342 4675
Email
fardash_s@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hosseinifar
Position
PhD in Physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy, Faculty of Rehabilitation Sciences, Razmojomoghadam Laboratory, Ayatollah Kafami St.
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
6485598136
Phone
+98 54 3342 4675
Email
fardash_s@zaums.ac.ir
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
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
All the main outcome data can be shared.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers and experts in this field must ensure that data is not misused
From where data/document is obtainable
afsanehsamiei72@yahoo.com
What processes are involved for a request to access data/document
The applicant must be fully and transparently identified and express his intention at his request. About 2 to 4 weeks after verification, the data will reach him.