If Kinesio tape can reduce the symptoms of low back pain during pregnancy and improve the function, it can be recommended as a cheap and uncomplicated treatment.
Design
A double-blind clinical trial with a control group, a sample size of 80 people, simple random
Settings and conduct
A Kinesio tape with a length of approximately 20 cm and a width of 5 cm with a 50% stretch is placed vertically from the bottom of the pain area upward at a distance of 2 cm from the spine on a clean, non-greasy and lotion free skin. Another tape is placed parallel to the first one on the other side of the spine at a distance of 4 cm from the first tape. Another tape is transversely placed with a 70% stretch in the sacroiliac region. Another tape without stretching is inserted on the abdominal region to reduce the pressure of the lumbar vertebrae and support the abdominal muscles. Participants and evaluators are blinded to the sampling.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Written informed consent
Age:18-40 years old
Being pregnant in the second or third trimester (gestational age of18-32 week),
Mild to moderate low back pain (Visual analogue scale 1-7)
No known or suspected orthopedic or rheumatologic disorders including scoliosis, spine injuries,rheumatoid arthritis
No known intervertebral discopathy
No skin lesion in the lumbosacral area
No vertebral anomaly
No skin allergy
Singleton pregnancy
No history of low back pain prior to pregnancy
No addiction
No NSAID consumption
No history of other non-medical treatments
Exclusion criteria:Allergy to kinesio tape
kinesio tape coming off before the fifth day
Any uncontrolled medical condition
Intervention groups
The intervention group receives Kinesio tape.
The control group receives leukoplast tape.
Main outcome variables
Low back pain, performance dysfunction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181210041911N1
Registration date:2019-04-07, 1398/01/18
Registration timing:registered_while_recruiting
Last update:2019-04-07, 1398/01/18
Update count:0
Registration date
2019-04-07, 1398/01/18
Registrant information
Name
Seyede maryam Lotfipur rafsanjany
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
m.lotfi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-18, 1397/10/28
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of kinesio tape on low back pain and performance dysfunction in pregnant women presenting to comprehensive health centers
Public title
The effect of kinesio tape on low back pain and performance dysfunction in pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent
Age:18-40 years old
Being pregnant in the second or third trimester (gestational age of 18-32 week)
Mild to moderate low back pain (Visual analogue scale 1-7)
No known or suspected orthopedic or rheumatologic disorders including scoliosis, spine injuries,rheumatoid arthritis
No known intervertebral discopathy
No skin lesion in the lumbosacral area
No vertebral anomaly
NO skin allergy
Singleton pregnancy
NO history of low back pain prior to pregnancy
No addiction
No NSAID consumption
No history of other non-medical treatments
Exclusion criteria:
Allergy to kinesio tape
kinesio tape coming off before the fifth day
Any uncontrolled medical condition
Severe low back pain (Visual analogue scale 7-10)
Unwillingness to continue the study
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by tossing a coin (to determine the first group)
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and outcome evaluators are blinded to sample ellocation of the groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of rafsanjan university of medical sciences
Street address
Rafsanjan-Imam Ali Blvd. - Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2019-01-18, 1397/10/28
Ethics committee reference number
IR.RUMS.REC.1397.183
Health conditions studied
1
Description of health condition studied
Low back pain and Performance disability of the second and third trimester of pregnancy
ICD-10 code
O26.8
ICD-10 code description
Other specified pregnancy related conditions
Primary outcomes
1
Description
Low back pain score with visual analogue scale(vas)
Timepoint
Measurement of low back pain before intervention and 1،2،7 and 14 days after intervention
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Functional disability score with Roland morris disability questionnaire
Timepoint
Measurement of disability before intervention and 7،14 days after intervention
Method of measurement
Roland morris disability questionnaire
Intervention groups
1
Description
The intervention group: Kinesio adhesive tape, 5-meter roll and 5 cm wide (made in Korea). two strips of 20 centimeters with a width of 5 centimeters are placed with medium stretching from the bottom of the pain area upwards on the sides of the spine,another with 70% stretching is attached transversally to the sacroiliac joint.To reduce the pressure of the lumbar vertebrae and support the abdominal muscles, a tape is also inserted on the stomach without stretching.The tapes are removed on day 5 by the participant.
Category
Treatment - Other
2
Description
the control group: Leukoplast tape, 5 m long and 5 cm wide (made in China). Two 20 cm tape strips with a width of 5 cm are placed from the bottom of the pain area upward on the sides of the spine.Another tape is transversely attached to the sacroiliac joint to reduce the pressure of the lumbar vertebrae and support the abdominal muscles. A tape is also inserted on the abdomen. The tapes are removed on day 5 by the participant.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health center no.five
Full name of responsible person
Tayebeh Alishahi
Street address
Kargar street
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
INFO@RUMS.AC.IR
2
Recruitment center
Name of recruitment center
Comprehensive health center no.one
Full name of responsible person
Tayebeh Alishahi
Street address
Imam Khomeini Street, Quds Field
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
INFO@RUMS.AC.IR
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsi Zadeh
Street address
Imam Ali Blvd, Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Fax
+98 34 3428 0071
Email
Info@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Tayebeh alishahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing Ave, Motahhari Blvd Faculty of Nursing, Midwifery,
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
Email
www.alishahitayebeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Seyyedeh Maryam Lotfipour Rafsanjani
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing Ave, Motahhari Blvd Faculty of Nursing Midwifery
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 343434255900
Email
www.maryam_lotfipur@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Seyyedeh Maryam Lotfipour Rafsanjani
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing Ave, Motahhari Blvd Faculty of Nursing Midwifery
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 343434255900
Email
www.maryam_lotfipur@yahoo.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