Protocol summary

Study aim
The effect of 6 week aquatic exercise with Naturopathy method on pain The effect of 6 week aquatic exercise with Naturopathy method on disability The effect of 6 week aquatic exercise with Naturopathy method on the amount of muscle activity Gluteus maximos, Gluteus medios, multifidus The effect of 6 week aquatic exercise with Naturopathy method muscle activity time in persons with non_specific low back pain
Design
The experimantal study was quasi_experimental, two groups of control and test, experimental.
Settings and conduct
Prior to the on set of aquatic exercise, both control and test groups consisted of 12 control and 12 test group. They were asked to visit the Quazvin city laboratory, After contfirming ethics in research and obtaining written consent form, information about high, weight, obtained from both groups.Then to evaluare the a mount and time of activity of the muscles of Gluteus maximos, Gluteus medios, multifidus surface Electromyography was performed and recorded by groups.The Quebec pain Questionnaire was used to assess pain and the Oscuster Questionnaire was used to assess disability by both groups. After that, aquatic exercise was started for the test groups.After exercise the control and test groups were again re_tested with post_ test surface Elecrromyography and pain and disability Questionnaires were distributed beteen the two groups. The controls group received no aquatic exercises
Participants/Inclusion and exclusion criteria
The inclusion criteria for women with non_specific chronic low back pain were in the age range of 25_40 years. They had no spine surgery and had acute low back pain Non_arrival conditions.
Intervention groups
Determine the effectiveness of aquatic exercise for persons with non_specific chronic low back pain.
Main outcome variables
Pain, Disability, The amount of muscle activity, Muscle activity time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200318046806N1
Registration date: 2020-04-03, 1399/01/15
Registration timing: retrospective

Last update: 2020-04-03, 1399/01/15
Update count: 0
Registration date
2020-04-03, 1399/01/15
Registrant information
Name
Fariba Bahrami eyvanaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3357 7449
Email address
faredamg7332@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-10, 1398/02/20
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2019-07-11, 1398/04/20
Actual recruitment end date
2019-08-23, 1398/06/01
Trial completion date
2019-08-23, 1398/06/01
Scientific title
Effect of a six week water based exercise with Naturopathy on pain and disability and the exent of muscle selective activity in non specific low back pain
Public title
Water exercise for people with non_specific low back pain
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
People with non_specific Be woman Age range from 25 to 40 years
Exclusion criteria:
Have spine surgery Acute low back pain
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method was used that in this method for generate random sequences Random allocation software was used.Then, central randomization method was used to allocation concealment.
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
Institute of physical Education.
Street address
Motahari
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-07-01, 1398/04/10
Ethics committee reference number
IR.SSRC.REC.1398.094

Health conditions studied

1

Description of health condition studied
Non_specific low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain.

Primary outcomes

1

Description
Pain
Timepoint
Pre_test, post_test
Method of measurement
Quebec questionnaire

2

Description
Ďisability
Timepoint
Pre_test, post test
Method of measurement
Osustery questionnaire

Secondary outcomes

1

Description
The amount of muscle activity
Timepoint
Pre_test, post_test
Method of measurement
Electromyography machine superficial

2

Description
Muscle activity time
Timepoint
Pre_test, post_test
Method of measurement
Electromyography machine superficial

Intervention groups

1

Description
Entervantion group۱: This group was taken before the start of aquatic exercise by surface electromyography ander the supervision of a neuro muscular specialist and filled out a Questionnaire on pain and disability. Then do the aquatic exercise were performed for 6 week, every week 3 sessions one hour ( 10_15 minutes harmup, 30_35 minutes maine exercise, 5_10 minutes coldup) done.After exercise the musclenerve band test was performed by a specialized surface electroyography done and anser Quebec questionnaire pain and Osustery questionnaire disability
Category
Rehabilitation

2

Description
Control group: This group had no role in the aquatic exercise. They taken only before and qfter the test by ekectromyography machin surface under of a neuromuscular specialist and anser the Quebic questionnaires of pain and Osustery questionnaire of disability.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Pool shahed
Full name of responsible person
Fariba Bahrami
Street address
Valiasr
City
Quazvin
Province
Qazvin
Postal code
3416816417
Phone
+98 28 3357 7449
Email
Faredamg7332@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University Raja
Full name of responsible person
Hadi Miri
Street address
Valiasr
City
Quazvin
Province
Qazvin
Postal code
3416816417
Phone
+98 28 3357 7449
Email
Hd.Miri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
شخص خودم
Proportion provided by this source
50
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
University raja
Full name of responsible person
Fariba Bahrami
Position
Coatch
Latest degree
Master
Other areas of specialty/work
Others
Street address
Valiasr
City
Quazvin
Province
Qazvin
Postal code
3416816417
Phone
+98 28 3357 7449
Email
Faredamg7332@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University raja
Full name of responsible person
Fariba Bahrami
Position
Coatch
Latest degree
Master
Other areas of specialty/work
Others
Street address
Valiasr
City
Quazvin
Province
Qazvin
Postal code
3416816417
Phone
+98 28 3357 7449
Email
Faredamg7332@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University raja
Full name of responsible person
Fariba Bahrami
Position
Coatch
Latest degree
Master
Other areas of specialty/work
Others
Street address
Valiasr
City
Quazvin
Province
Qazvin
Postal code
3416816417
Phone
+98 28 3357 7449
Email
Faredamg7332@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
Information the persons secret
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In the articles
When the data will become available and for how long
Not specified
To whom data/document is available
Researchers in academic and scientific instutions
Under which criteria data/document could be used
In the articles
From where data/document is obtainable
University raja
What processes are involved for a request to access data/document
The reason for the request should be clear
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