Plain English Summary
Background and study aims
Low back pain is a common cause of disability and can make daily functioning difficult. For some women, low back pain can last for a long time or return on a regular basis after giving birth. Exercise and physical activity are some of the ways in which patients can relieve their low back pain. This can be helped by a physical therapist, who can help these women improve their quality of life by relieving the pain.
This study aims to look at the difference between the effects of core stability exercises and Swiss ball exercises for the relief of low back pain in women after giving birth.
Who can participate?
Women with low back pain for over 2 months after giving birth
What does the study involve?
Participants will be randomised into 2 groups - Group I and II. Group I will receive static core strengthening training, involving various stabilisation and strength exercises. Group II will undertake Swiss ball exercises. Participants in both groups will be supervised for these exercises and will be provided with a hot pack to use before each session. For both groups, the exercises will be completed 3 days per week for 2 months and participants will be assessed before and 8 weeks after the start of the exercise program.
What are the possible benefits and risks of participating?
The possible benefit of taking part is relief from low back pain, which can improve their quality of life. There are no known risks to participants taking part in this study.
Where is the study run from?
Pakistan Railway General Hospital Rawalpindi, Pakistan
When is the study starting and how long is it expected to run for?
March 2018 to December 2018
Who is funding the study?
Riphah International University Islamabad (Pakistan)
Who is the main contact?
Prof Dr Syed Shakeel Ur Rehman
shakil.urrehman@riphah.edu.pk
Trial website
Contact information
Type
Public
Primary contact
Prof Syed Shakil Rehman
ORCID ID
http://orcid.org/0000-0002-6682-9896
Contact details
Riphah College of Rehabilitation Sciences
274
main Peshawar road
Rawalpindi
46000
United Arab Emirates
+923207866611
shakil.urrehman@riphah.edu.pk
Additional identifiers
EudraCT number
NA
ClinicalTrials.gov number
NA
Protocol/serial number
NA
Study information
Scientific title
Effects of Static Core Muscles Stability Exercise versus Swiss ball training program in patients with post-partum low back pain
Acronym
NA
Study hypothesis
There will be a difference in the effects of the static exercise program and Swiss ball training in postpartum low back pain
Ethics approval
Research Ethical Committee, Riphah College of Rehabilitation Sciences Riphah International University, Islamabad, 20/03/2018, Riphah/RCRS/REC/00294
Study design
Interventional randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
Postpartum low back pain
Intervention
Participants will be assessed in a physiotherapy OPD and will be randomly divided into 2 groups using the lottery method. One group will undertake static core muscle strengthening exercises, whilst the other will undertake Swiss ball exercises.
All participants will undergo an examination at the baseline (day 1) and after 8 weeks, which will assess pain, character of pain, nature of pain, aggravating factors, relieving factors and any ongoing treatment. Pain will be assessed using the NPRS, flexion and extension ranges will be measured using an inclinometer, core muscle strength will be assessed using the CSA scale and functional status will be assessed using the Oswestry disability scale.
Participants in both groups will apply a hot pack prior to taking part in the exercises.
Participants in the group undertaking static core muscle strengthening exercises will be asked to perform the following:
1. Bridging (stabilisation)
2. Plank (stabilisation and strength)
3. Side plank (integrated stabilisation)
4. Bird dog (integrated stabilisation)
These exercises will be completed 3 days per week for 2 months. For the stretching exercises, there will be 10 sets of 15 second holds. For the strengthening exercises, there will be 2 sets of 15 repetitions.
Participants in the group undertaking Swiss ball exercises will be asked to perform the following:
1. Stability-ball-elevated split squat
2. Stability ball hamstring curl
3. Dead bug
4. Stability ball Y-ups
These exercises will be completed 3 days per week for 2 months. For the stretching exercises, there will be 3 repetitions of 10 second holds. For the strengthening exercises, there will be 1 set of 10 repetitions.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
The following will be measured at the baseline (day 1) and after 8 weeks:
1. Pain assessed using the Numeric Pain Rating Scale (NPRS)
2. Functional status assessed using the Oswestry disability index (ODI)
3. Core muscle strength assessed using the Core Stability Assessment Scale (CSA)
Secondary outcome measures
Current secondary outcome measures as of 26/09/2018:
Flexion and extension range measured at the baseline (day 1) and after 8 weeks using an incliometer
Previous secondary outcome measures
Flexion and extension range measured at the baseline (day 1) and after 8 weeks using a goniometer (goniometry of lumbar spine)
Overall trial start date
01/03/2018
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 25-35 years
2. Postpartum back pain for period of 2-8 months
3. Normal delivery during birth
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
30
Participant exclusion criteria
1. Cesarean delivery
2. Systemic, bone and soft tissue diseases i.e. lumbar spinal stenosis, spondylosis, lumbar radiculopathy, spinal cord injury, herniated lumbar disc, ankylosing spondylitis, rheumatoid arthritis, osteoporosis
Recruitment start date
15/08/2018
Recruitment end date
31/10/2018
Locations
Countries of recruitment
Pakistan
Trial participating centre
Pakistan Railway General Hospital
Pakistan Railway General Hospital Rawalpindi near Dhok Hassu, Railway workshop road scheme 7, Rawalpindi.
Rawalpindi
46000
Pakistan
Sponsor information
Organisation
Riphah International University islamabad
Sponsor details
Riphah College of Rehabilitation Sciences
plot # 50
street #5
H-8/2 Islamabad
Islamabad
pakistan
44000
Pakistan
+923207866611
shakil.urrehman@riphah.edu.pk
Sponsor type
University/education
Website
Funders
Funder type
Not defined
Funder name
Riphah International University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high impact peer reviewed journal
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Shakeel ur Rehman (shakil.urrehman@riphah.edu.pk)
Intention to publish date
01/12/2018
Participant level data
Available on request
Basic results (scientific)
NA
Publication list
NA
Publication citations
Additional files
- ISRCTN14142103_PIS.docx Uploaded 02/04/2019