Home » Trials » SLCTR/2020/012
The effects of therapeutic exercises for pregnancy-related low back pain
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SLCTR Registration Number
SLCTR/2020/012
Date of Registration
The date of last modification
Sep 10, 2020
Scientific Title of Trial
The effects of therapeutic exercises for pregnancy-related low back pain
Public Title of Trial
The effects of therapeutic exercises for patients with pregnancy-related low back pain compared to standard antenatal care – A randomized controlled trial
Disease or Health Condition(s) Studied
Pregnancy-related low back pain
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1251-8100
Any other number(s) assigned to the trial and issuing authority
UCP/LE/15/345:ERC Colombo
What is the research question being addressed?
Are there any effects of therapeutic exercises for pregnancy related low back pain compared to standard antenatal care in patients with pregnancy related lower back pain?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Uncontrolled
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
MOH office in Maharagama and Pamunuwa will be selected as the study setting.
60 mothers with pregnancy-related low back pain, will be assessed and allocated to intervention and control groups through a simple random sampling method by the medical officer in each clinic.
Back pain will be assessed by the symptoms 30 mothers who attended to the MOH clinic Maharagama, will be considered for the intervention group and other 30 mothers attending to the MOH clinic Pamunuwa will be considered for the control group.
Mothers in the intervention group will be matched to the controlled group by the gestational age of the pregnancy.
The intervention will include 30 minutes structured therapeutic exercise program which will be given to the intervention group. First a Powerpoint presentation regarding back care during pregnancy will be delivered by the Principal investigator to both groups.
The exercise program will be conducted in the study group during the next 3 weeks on 3 days of a week by the PI at the study setting.
One exercise program will last for 30 min.
The exercise program consists of warming up exercises, stretching exercises, strengthening exercises and cooling down techniques. The study group will attend the exercise classes on top of routine antenatal care while the control group will only receive normal antenatal care.
Inclusion criteria
Pregnant mothers who are * Aged 20-38 years
20-28 weeks of gestation
Carrying a single live fetus
Exclusion criteria
Pregnant women with, * History of 2nd trimester miscarriages * History of IUD/ Still birth • Past lower segment caesarean section * Pre-existing back pain/diagnosed with other musculoskeletal disorders • Contraindications to do exercises • Any medical or surgical condition complicating pregnancy
Primary outcome(s)
|
1.
Pain measured by Visual pain analogue scale |
[ At the recruitment point and 3 weeks after introducing the intervention ] |
|
2.
Disability assessed by the Oswestry Disability Index |
[ At the recruitment point and 3 weeks after introducing the intervention ] |
Secondary outcome(s)
|
1.
None |
[] |
Target number/sample size
60 (30 in one arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2020-06-01
Anticipated end date
2020-12-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self funded
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2019-07-09
Approval number
UCP/LE/15/345
Details of Ethics Review Committee
| Name: | Ethic review committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | P O Box 271, Kinsey Road,Colombo 8, Sri Lanka. |
| Telephone: | +94-11-2695300 |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
S.C.M.P.Pamunuwa
Student of Physiotherapy
Department of Allied Health Sciences, Faculty of Medicine, University of Colombo,
271, Kinsey Road, Colombo 08.
0714240385
chathuripamunuwa@gmail.com
Contact Person for Public Queries
Dr. T.N. Samaranayake
Senior lecturer, Department of Parasitology
Department of Parasitology, Faculty of Medicine, University of Colombo.
271, Kinsey Road, Colombo 8.
0112695300
0718297246
nilakshis35@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
