Home » Trials » SLCTR/2020/012

The effects of therapeutic exercises for pregnancy-related low back pain


SLCTR Registration Number


Date of Registration

08 May 2020

The date of last modification

Sep 10, 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


Public Acronym


Brief title


Universal Trial Number


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


Study design


Randomized controlled trial


Masking not used






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)


Pain measured by Visual pain analogue scale


At the recruitment point and 3 weeks after introducing the intervention


Disability assessed by the Oswestry Disability Index


At the recruitment point and 3 weeks after introducing the intervention


Secondary outcome(s)




Target number/sample size

60 (30 in one arm)

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source

Self funded

Regulatory approvals

Not applicable

State of Ethics Review Approval



Date of Approval


Approval number


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.
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Student of Physiotherapy
Department of Allied Health Sciences, Faculty of Medicine, University of Colombo, 271, Kinsey Road, Colombo 08.



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.


Primary study sponsor/organization

Faculty of Medicine, University of Colombo

Faculty of Medicine, University of Colombo.271, Kinsey Road, Colombo 08.

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Study protocol available


Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results