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Assesment of spinal thoracolumbosacral manipulation's effect on pain in women with primary dysmenorrhea in emam reza hospital, Tehran in 1395

Protocol summary

Study aim
1.determine pain intensity in lower abdomen according to VAS in case and control groups before and after manipulation in first, second and third cycles 2.determine pain intensity in pelvicaccording to VAS in case and control groups before and after manipulation in first, second and third cycles 3.determine pain intensity in low back according to VAS in case and control groups before and after manipulation in first, second and third cycles 4.detemine NSAIDs tablet consumption in case and control groups before and after manipulation in first, second and third cycles 5. detemine bleeding in case and control groups before and after manipulation in first, second and third cycles
Design
Two arm parallel group randomised trial with blinded outcome assessment
Settings and conduct
we explain study planning for all patients, based on patient satisfaction, she enters one of two groups.Patients are examined by a researcher number two who is blind to the grouping of patients, and measure spinal range of motion in Emam reza hopital. Patients in intervention group havr been manipulated in lumbosacral region and thoracolumbar junction at 15,21 and 28 days after menstruation onset. streching and strengthening exercise are thaught to both groups that they start at 15th cycle and stop with menstruation.all patien can take diclofenac 50 mg.
Participants/Inclusion and exclusion criteria
inclusion criteria: age 18-45 years, regular menstrual cycles , moderate to severe pain , dysmenorrhea symptom during 1 year ago , VAS more than 5 for pelvic pain , low back pain ,no manipulation 2 month before
Intervention groups
Intervention group:manipulate lumbosacral and thoracolumbar junction +6 type strengthening and streching abdominal exercises Controm grouo:the same intervention group exercise
Main outcome variables
pain (VAS) in low back , pelvic , lower abdomen determine bleeding , diclofenac intake

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180113038348N1
Registration date: 2018-04-24, 1397/02/04
Registration timing: retrospective

Last update: 2018-04-24, 1397/02/04
Update count: 0
Registration date
2018-04-24, 1397/02/04
Registrant information
Name
Hoda Jazayeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8827 2477
Email address
hoda.jazayeri@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-20, 1395/08/30
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
2016-11-20, 1395/08/30
Actual recruitment end date
2018-03-10, 1396/12/19
Trial completion date
empty
Scientific title
Assesment of spinal thoracolumbosacral manipulation's effect on pain in women with primary dysmenorrhea in emam reza hospital, Tehran in 1395
Public title
Assesment of spinal thoracolumbosacral manipulation's effect on pain in women with primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
regular menstrual cycles moderate to severe menstrual pain no manipulation 2 month before arrival in study Minimum age 18 and maximum age 45 year old
Exclusion criteria:
use OCP tablet or IUD pelvic abnormality endometriosis PCOS ,fibroid , PID , cancer spinal fracture
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 34
Actual sample size reached: 32
Randomization (investigator's opinion)
Randomized
Randomization description
randomization is done through randomized number table
Blinding (investigator's opinion)
Single blinded
Blinding description
Evaluator is blinded toward the group of patients
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics commitee of AJA university of medical science
Street address
Etemad zade st,west fatemi st
City
Tehran
Province
Tehran
Postal code
88028350
Approval date
2016-10-02, 1395/07/11
Ethics committee reference number
IR.AJAUMS.REC.1395.20

Health conditions studied

1

Description of health condition studied
dysmenorhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea

Primary outcomes

1

Description
pain score
Timepoint
15th first menstruation and 15th second menstruation
Method of measurement
VAS

Secondary outcomes

1

Description
lumbosacral junction ROM
Timepoint
15th first menstruation and 15th second menstruation
Method of measurement
measured by Zebris

2

Description
thoracolumbar junction
Timepoint
15th first and second menstruation cycles
Method of measurement
measured by goniometer

3

Description
number of diclofenac 50 mg that was used
Timepoint
first and second menstruation cycles
Method of measurement
number

4

Description
volume of bleeding
Timepoint
first and second cycles
Method of measurement
number of used pad

Intervention groups

1

Description
Intervention group: Performing manipulation on days 15, 21 and 28 of the patient's cycle simultaneously with strengthing and stretching exercises starting from 15 cycles and stop with menstruation oncet
Category
Treatment - Other

2

Description
Control group: From the 15th cycle until the menstruation oncet, they perform 6 strenghtening and streching exercises
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Hoda jazayeri
Street address
Etemad zade st,West Fatemi st,Emam Reza hospital
City
Tehran
Province
Tehran
Postal code
9132616040
Phone
+98 21 8802 8350
Email
hoda.jazayeri@ajaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Kamran Azma
Street address
Etemad zade St,West Fatemi St,Emam Reza Hospital
City
Tehran
Province
Tehran
Postal code
9132616040
Phone
+98 21 8802 8350
Email
hoda.jazayeri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Hoda Jazayeri
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Etemad zade St,West Fatemi St,Emam Reza Hospital
City
Tehran
Province
Tehran
Postal code
9132616040
Phone
+98 21 8802 8350
Email
hoda.jazayeri@ajaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Hoda Jazayeri
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Etemad zade St,West Fatemi St,Emam Reza Hospital
City
Tehran
Province
Tehran
Postal code
9132616040
Phone
+98 21 8802 8350
Email
hoda.jazayeri@ajaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Hoda Jazayeri
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Etemad zade St,West Fatemi St,Emam Reza Hospital
City
Tehran
Province
Tehran
Postal code
9132616040
Phone
+98 21 8802 8350
Email
hoda.jazayeri@ajaums.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
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