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

08 May 2020

The date of last modification

May 08, 2020



Application Summary


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


Trial Details


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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

Faculty of Medicine, University of Colombo

Faculty of Medicine, University of Colombo.271, Kinsey Road, Colombo 08.
+94-11-2695300


Secondary study sponsor (If any)







Trial Completion details


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