To find the effects of Abdominal Strengthening exercises with and without Transcutaneous electrical nerve stimulation in patients with Primary Dysmenorrhea.
Design
Two groups, Single blinded, Randomized Controlled Trial.
Settings and conduct
The Perfect Physio And Spine Care Centre, Asjad Clinic, Minhaj Hospital.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Females aged 20 to 30 years;
The characteristic of pain must be periodic (at least following 3 menstrual cycles) and gradually diminishes over 12 to 72 hours, ends after period.
The pain must start generally in 2 to 3 years after start of menarche; regular menses (25-31 day).
Exclusion Criteria:
Chronic abdominal pain.
Fibroids.
Irritable bowel syndrome.
Intervention groups
Group A: Abdominal strengthening exercises with TENS.
Group B: Abdominal strengthening ecexercises without TENS.
Main outcome variables
Work, ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD)
Owestry Disability Index (ODI)
Numeric Pain Rating Scale (NPRS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191218045777N1
Registration date:2020-01-12, 1398/10/22
Registration timing:registered_while_recruiting
Last update:2020-01-12, 1398/10/22
Update count:0
Registration date
2020-01-12, 1398/10/22
Registrant information
Name
sana qaisar
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
maazqaisar00786@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-01, 1398/09/10
Expected recruitment end date
2020-01-15, 1398/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of abdominal strengthening exercises with and without transcutaneous electrical nerve stimulation in patient with primary dysmenorrhea.
Public title
Effects of abdominal strengthening exercises with and without transcutaneous electrical nerve stimulation in patient with primary dysmenorrhea.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Females aged of 20 to 30 years.
Nulliparous patients with symptoms of severe primary dysmenorrhea.
The characteristic of pain must be periodic (at least following 3 menstrual cycles).
Lower abdominal cramps or pelvic colic like pain that starts up to one day before menses lasts for the 3 days of bleeding.
Gradually diminishes over 12 to 72 hours, ends after period.
The pain must start generally in 2 to 3 years after menarche with regular menses (25-31 day).
Exclusion criteria:
Patients with history of pelvic inflammatory diseases (endometriosis, ovarian cysts).
Chronic abdominal pain.
Fibroids.
Irritable bowel syndrome.
Major abdominal or pelvic surgery.
Intrauterine device and patients treated with oral contraceptive pills was contraindicated.
Patients enrolled simultaneously into other studies that require drug intake or otherwise prevent compliance with protocol.
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Written informed consent will be taken. After enrollment into study, patient will be allocated either to group A or Group B by lottery method. No. of Chits will be equal to total sample size, odd Numbers will be allocated to Group A and even number will be allocated to Group B. Each patient will be requested to draw a chit from the box and after that patient will be recruited into either Group A or Group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessor blind: Data Being secretive will be ensured by assigning specific identity number and all documents and forms will be placed in locker to blind assessors.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Secretary ethical review committee, Riphah College of Rehabilitation and Allied Health Sciences
Street address
28-M,Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Postal code
54000
Approval date
2019-09-19, 1398/06/28
Ethics committee reference number
Ref. No,RCR & AHS/REC/MS-NMPT/S19/007
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Pain
Timepoint
Before treatment and after completing the session
Method of measurement
Numeric pain rating scale (NPRS).
Secondary outcomes
1
Description
Low back pain/symptoms severity
Timepoint
Before and after completing treatment session
Method of measurement
Owestry disability index (ODI).
2
Description
Severity of dysmmenorrhea
Timepoint
Before and after completing the session
Method of measurement
Working ability, Location, Intensity, Days of pain, Dysmmenorrhea (WaLIDD).
Intervention groups
1
Description
Intervention group A Abdominal strengthening exercises with TENs
Category
Treatment - Other
2
Description
Intervention group B Abdominal strengthening exercises without TENs
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The Perfect Physio And Spine Care Centre
Full name of responsible person
Dr Saqib Fareed
Street address
The Perfect Physiotherapy and spine care Center, Opposite Faisal Stadium, D.G. Khan Road, Muzaffar Garh
City
Muzaffargarh
Postal code
34200
Phone
+92 66 2423000
Email
jugnomsf26@gmail.com
2
Recruitment center
Name of recruitment center
Minhaj hospital
Full name of responsible person
Dr Aslam Minhaj
Street address
Ganishwa pool, near puranI Sabiz Mandi, Minhaj hospital.
City
Muzaffargarh
Postal code
34200
Phone
+92 66 2423000
Email
marifkhore@gmail.com
3
Recruitment center
Name of recruitment center
Asjad clinic
Full name of responsible person
Dr salma Ghouri
Street address
near city public school, karbala road, muzaffargarh
City
Muzaffargarh
Postal code
34200
Phone
+92 66 2423000
Email
kousarmehwish00786@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Street address
28-M Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
20
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
28-M, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam, Industrial Estate, kot Lakhpat, Lahore