The effect of vibration therapy and muscle relaxation on nurses' low back pain is determined.
Design
This study is a clinical trial in intervention phase in humans. The sample size is 110 nurses who are assigned to parallel groups using the random numbers table. In this triple blind study, all samples, data collector, and data analyzers are unaware of the type of intervention.
Settings and conduct
This study was performed on 110 nurses with low back pain working in Vali-e-Asr hospital of Arak divided to two groups: first group (vibration therapy) and the second group (muscle relaxation) by convenience sampling.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Nurses with low back pain and low back pain symptoms
Exclusion criteria: Taking medication
Intervention groups
Intervention: In the first group,Vibration therapy was done in one group one time about 10 minutes daily for two weeks. In the second group, Muscle relaxation method was done one time about 20 minutes on nurses daily for two weeks. Then pain rate was measured before and after of the intervention with pain intensity scale.
Main outcome variables
Lower back pain
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20160618028511N3
Registration date:2019-03-05, 1397/12/14
Registration timing:retrospective
Last update:2019-03-05, 1397/12/14
Update count:0
Registration date
2019-03-05, 1397/12/14
Registrant information
Name
Pouran Varvani Farahani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3506
Email address
varvanif@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
2015-09-23, 1394/07/01
Actual recruitment end date
2015-11-22, 1394/09/01
Trial completion date
2015-11-22, 1394/09/01
Scientific title
Comparing the effect of vibration therapy and muscle relaxation on nurses with back pain
Public title
vibration therapy and muscle relaxation on back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Low back pain diagnosis and low back pain symptoms
Employed in a department of Valiasr Hospital in Arak, as a nurse or head nurse
The desire to participate in the study
No Smoking and Drug Addiction
Exclusion criteria:
Taking medication
Unwillingness to participate in the research
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
110
Actual sample size reached:
110
Randomization (investigator's opinion)
Randomized
Randomization description
All nurses as samples were allocated into two groups based on tables of random numbers (odd and even).The 3-digit numbers were selected from the top left of the table and continued down the row, and all the even numbers were assigned to the intervention group and the odd numbers to the control group. This practice continued until the completion of samples of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The samples of each group were completely unaware of the intervention method in the other group.In fact, only general points about no risk interventions on control of back pain were explained to them, and the operational and detailed contents of the intervention methods did not express. The data collector was also unaware of the type of intervention in the group. Also, the data analyst was unaware of the type of intervention in each group.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Arak University of Medical Sciences
Street address
Sardasht ,Basij square, Arak University of Medical Sciences,School of Nursing
City
Arak
Province
Markazi
Postal code
3848-7-6941
Approval date
2013-05-01, 1392/02/11
Ethics committee reference number
92-151-5
Health conditions studied
1
Description of health condition studied
low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Relief of back pain
Timepoint
At beginning of study and 2 weeks after intervention
Method of measurement
pain intensity scale and pain assessment flow sheet
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Therapeutic vibration: Vibration therapy was performed 1 time a day and 10 minutes each (for 2 weeks). Therapeutic vibration was performed by a vibrating device of Japan with a frequency of 20 Hz, which was performed by a researcher fellow in 14 days.
Category
Rehabilitation
2
Description
Second intervention group: Muscle relaxation: Muscle relaxation was performed in the form of sound recorded by the audio player. Then the nurses underwent muscle relaxation at home every day (for 2 weeks). The intervention took place within 14 days.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Hospital in Arak
Full name of responsible person
Pouran Varvani Farahani
Street address
Sardasht ,Basij square, Arak University of Medical Sciences,School of Nursing
City
Arak
Province
Markazi
Postal code
3848-7-6941
Phone
+98 86 3417 3505
Fax
+98 86 3417 3524
Email
varvanif@arakmu.ac.ir
Web page address
http://www.arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Arjmandzadegan
Street address
Sardasht ,Site Pardis, Arak University of Medical Sciences,Department of Education and Research
City
Arak
Province
Markazi
Postal code
3848-7-6941
Phone
+98 86 3417 3645
Fax
+98 86 3417 3645
Email
mmatinam81@yahoo.com
Web page address
http://www.arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Pouran Varvani Farahani
Position
Master of Pediatrics education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sardasht ,Basij square, Arak University of Medical Sciences,School of Nursing
City
Arak
Province
Markazi
Postal code
38481-7-6941
Phone
+98 86 3417 3505
Fax
+98 86 3417 3524
Email
varvanif@arakmu.ac.ir
Web page address
http://www.arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpou
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sardasht ,Basij square, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
38481-7-6941
Phone
+98 86 3417 3505
Fax
+98 86 3417 3521
Email
dr_hekmat@arakmu.ac.ir
Web page address
http://arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Pouran Varvani Farahani
Position
Master of Pediatrics education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sardasht ,Basij square, Arak University of Medical Sciences,School of Nursing
City
Arak
Province
Markazi
Postal code
38481-7-6941
Phone
+98 86 3417 3505
Fax
+98 86 3417 3524
Email
varvanif@arakmu.ac.ir
Web page address
http://www.arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available