Protocol summary

Study aim
Determining the effect of Alexander technique on quality of life of patients after laminectomy
Design
A community-based, pragmatic, control group clinical trial was randomized with parallel groups.
Settings and conduct
Alexander technique will be taught for 8 weeks, two sessions a week, in 16 sessions and 60 minutes each session by an expert instructor in this field. All training of Alexander technique will be done in the indoor gym of Kashan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Age between 18 and 60 years with full consciousness One month to one and a half months after laminectomy surgery (cause of lumbar disc herniation surgery or spinal canal stenosis) ؛ No entry conditions : simultaneous use of other complementary therapies Cases of hospitalization, back injury and death Prohibition notified by a neurologist during the study In case of complications or exacerbation, it will be excluded from the study at the discretion of the physician Known mental disorder
Intervention groups
In the Alexander technique intervention group, for 8 weeks, two sessions per week, during 16 sessions and each session will be 60 minutes. The training will take place on Saturdays, Mondays of each week, so that female patients will return in the morning on the desired days and male patients in the afternoon of the same day. Both sexes will be trained by an expert instructor in this field. Patients in the control group have their previous therapies and do not receive any training on Alexander technique exercises.
Main outcome variables
Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20111210008348N46
Registration date: 2020-08-04, 1399/05/14
Registration timing: registered_while_recruiting

Last update: 2020-08-04, 1399/05/14
Update count: 0
Registration date
2020-08-04, 1399/05/14
Registrant information
Name
Neda Mirbagher
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
mirbagher_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-06, 1399/03/17
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Alexander technique on quality of life of patients after laminectomy
Public title
The effect of Alexander technique on quality of life of patients after laminectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 60 years Having full consciousness One month to one and a half months after laminectomy (due to low disc herniation or spinal canal stenosis)
Exclusion criteria:
simultaneous use of other complementary therapies Cases of hospitalization, back injury and death Prohibition notified by a neurologist during the study In case of complications or exacerbation, it will be excluded from the study at the discretion of the physician Known mental disorder
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation in the two groups of intervention and control uses the method of random blocks (7 blocks of 10 people) using software.
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
Ethics committee of Kashan University of Medical Sciences
Street address
Ravand Street, Kashan University of Medical Sciences.
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2020-06-06, 1399/03/17
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1399.016

Health conditions studied

1

Description of health condition studied
Alexander's Technique
ICD-10 code
Z50
ICD-10 code description
Care involving use of rehabilitation procedures

Primary outcomes

1

Description
Quality of life
Timepoint
Before and one month after the intervention
Method of measurement
SF36 quality of life questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The Alexander technique will be performed for 8 weeks, two sessions a week, in 16 sessions, each session lasting 60 minutes. The instructor will be trained in this field. It will be provided to patients to motivate them to participate in research and perform this technique regularly. Then the training of this technique begins, which includes the first and second sessions, including keeping the head correctly in the position of walking and standing, and sports exercises in this field.The Alexander technique will be performed for 8 weeks, two sessions a week, in 16 sessions, each session lasting 60 minutes. The instructor will be trained in this field. It will be provided to patients to motivate them to participate in research and perform this technique regularly. Then the training of this technique begins, which includes the first and second sessions, including keeping the head correctly in the position of walking and standing, and sports exercises in this field. The third session includes teaching the correct way to sit and stand and sports exercises in this field, the fourth and fifth sessions include teaching the correct method of bending and lifting objects from the ground and working in a bent position and sports exercises in this field, the sixth session of the method training Proper carrying of bags, equipment and sports exercises in this field, the seventh session, the correct method of sitting and sports exercises in this field, and in the last session, the correct postures of the face, eyes and breathing will be taught.
Category
Treatment - Other

2

Description
Control group: Patients in the control group have their previous therapeutic procedures and do not receive any training on Alexander technique exercises. At the end of the study, if the technique is effective, a training booklet on the Alexander technique will be provided to patients in the control group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital and Naghavi Hospital of Kashan
Full name of responsible person
Neda Mirbagher
Street address
Kashan Ravand street,Shahid Beheshti Hospital and Ayatollah Kashani Street next to the intersection of Ayatollah Kashani Naghavi Hospital
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
amirmohammadalborzi60@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafsheh
Street address
Ravand Street, Kashan University Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 31 5554 6633
Email
amirmohammadalborzi60@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan,RavandStreet,Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan,Ravand street, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir Mohammad Alborzi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faramarzieh town, Mahbod street, Shahid Mofteh alley, No. 14
City
Mallard
Province
Tehran
Postal code
۳۱۶۶۱۴۵۵۱۵
Phone
+98 21 6547 3431
Email
amirmohammadalborzi60@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
Data of participants are confidential
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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