To compare the effects of pelvic floor exercises and pelvic tilt exercises on low back pain during third trimester of pregnancy
Design
A randomized open-label parallel control group clinical trial.
Settings and conduct
Patients will be recruited according to the inclusion criteria of study, from Mola Bakhsh Hospital Sargodha and District Headquarter Hospital Sargodha. After this initial assessment will be performed and patients will be randomized in two groups to receive their respective treatment. Outcomes will be assessed before and after completion of treatment.
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA:
• Age limit 25 to 35
• Pregnant women with low back pain in 3rd trimester.
EXCLUSION CRITERIA:
• Systemic illness
• Traumatic injury
• Previous surgery.
Intervention groups
Intervention Group 1: Hot pack will be applied for 10 minutes and then pelvic tilt exercises will be performed for 15 minutes for the treatment of low back pain. 5 sessions/week will be given for 4 weeks.
Intervention Group 2: Hot pack will be applied for 10 minutes and then pelvic clock exercises will be performed for 15 minutes. 5 sessions/week will be given for 4 weeks. Treatment time of each session be approximately 25 minutes.
Main outcome variables
Visual analogue scale (VAS), Oswestry disability index (ODI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210730052018N1
Registration date:2021-09-09, 1400/06/18
Registration timing:retrospective
Last update:2021-09-09, 1400/06/18
Update count:0
Registration date
2021-09-09, 1400/06/18
Registrant information
Name
Bushra Mushtaq
Name of organization / entity
Government college university Faisalabad
Country
Pakistan
Phone
+92 48 3252717
Email address
bushaamushtaq213@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-04, 1400/05/13
Expected recruitment end date
2021-09-04, 1400/06/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Pelvic Clock vs Pelvic Tilt Exercises on pregnant women with low back pain during their third trimester
Public title
Effects of Pelvic Clock vs Pelvic Tilt Exercises on pregnant women with low back pain during their third trimester
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age limit 25 to 35
Pregnant women with low back pain in 3rd trimester
Exclusion criteria:
Any systemic illness
Gestational diabetes
Urinary tract infection
Multiple pregnancy
Complication during pregnancy
First and second trimester
Traumatic injury
Any previous surgery
Age
From 25 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Written informed consent will be taken. After enrollment into study, patients will be allocated either to Group 1 or Group 2 by lottery method. No. of chits will be equal to total sample size, odd no. will be allocated to Group 1 and even no. will be allocated to Group 2. Each patient will be requested to draw a chit from the box and after that patient will be recruited into either Group 1 or Group 2.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Non-probability purposive sampling will be used to recruit the individual for the study and then randomization will be done by lottery method to allocate the individual to two interventional groups. Sealed envelops will be used for allocation concealment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sargodha Institute of Health Sciences (SIHS), Research Ethical Committe (REC)
Low back pain is leading health problem in lumbosacral region. It is defined by muscle tension, or stiffness localized below the costal margin and above the inferior gluteal folds. The symptoms of low back pain occurs in people of all ages .The low back pain symptoms may be short lasting but frequent occurrence is common , the acute episode lasts from few days to four weeks while sub-acute phase of low back pain lasts for four to twelve weeks and chronic low back pain persists from months and years. It is a composite condition with several contributing factors involving psychological factors, social factors and biophysical factors
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
pain
Timepoint
before treatment, after treatment (4th week)
Method of measurement
Visual analogue scale (VAS)
2
Description
Functional performance
Timepoint
before treatment, after treatment (4th week)
Method of measurement
Oswestry Disability Index (ODI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: After taking baseline measures group A patients will receive hot pack for 10 minutes and pelvic tilt exercise for 15 minutes. 5 sessions/ week will be given for 4 weeks
Category
Other
2
Description
Intervention group 2: After taking baseline measures group B patients will receive hot pack for 10 minutes and pelvic clock exercise for 15 minutes. 5 sessions/week will be given for 4 weeks. Treatment time of each session will be approximately 25 minutes