Plain English Summary
Background and study aims
Low back pain is a common cause of disability and can make daily functioning difficult. Some females who have given birth by C-section may have low back pain for a long time afterwards or on a regular basis. Exercise and physical activity are some of the ways in which patients can relieve their low back pain, and this can sometimes be supervised by a physical therapist.
This study aims to look at the difference between a core stability exercise program for women with post-C-section low back pain, either supervised by a physical therapist or unsupervised at home.
Who can participate?
Women who have had low back pain as a result of a C-section for at least 2 months
What does the study involve?
Participants will be randomised into 2 groups. Both groups will receive the same core stability exercise training for a period of 6 weeks; however, Group I will undergo a supervised program, whereas Group II will undergo an unsupervised program. Both groups will also receive a hot pack to use.
Group I will receive supervised training, with 3 sessions per week for 6 weeks. Every 2 weeks, participants will progress to the next level of the exercises. Group I will also receive TENS treatment.
Group II will have 1 training session and will be provided with written materials explaining how to complete the exercises at home, and will be provided with a hot pack to use at home.
What are the possible benefits and risks of participating?
The possible benefits of taking part for participants is that they may have relief from low back pain and their core muscle strength will improve. There are no known risks to participants taking part in this study.
Where is the study run from?
Helping Hand for Relief and Development (HHRD) Comprehensive Rehabilitation Centre Chakwal, Pakistan
When is the study starting and how long is it expected to run for?
February 2018 to December 2018
Who is funding the study?
Riphah International University (Pakistan)
Who is the main contact?
Dr Syed ShakeelurRehman
shakil.urrehman@riphah.edu.pk
Trial website
Contact information
Type
Scientific
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
Pakistan
+923207866611
shakil.urrehman@riphah.edu.pk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NA
Study information
Scientific title
Effects of supervised versus unsupervised home-based core stability exercise programs in post C-section low back pain
Acronym
Study hypothesis
There is a difference between supervised versus unsupervised home-based core stability exercise program in patients with post C-section low back pain.
Ethics approval
Research Ethical Committee, Riphah College of Rehabilitation Sciences, Riphah International University, Islamabad, Pakistan, 20/03/2018, Riphah/RCRS/REC/00345
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Post C-section low back pain
Intervention
Informed consent will be taken from all the study participants. The participants will then be asked to complete Oswestry Disability Index and a questionnaire of open-ended questions. 40 participants will be assessed relating to low back pain associated with having had a C-section. 31 of these participants will be selected by convenient sampling. Following this, participants will be randomly assigned into either group I (14 participants) or II (17 participants) using the see through envelope method. Both groups will receive the same core stability exercise program; however, group I will be treated with a supervised version, whereas group II will be provided with an unsupervised, home-based core stability exercise program. Both the supervised and unsupervised programs have a duration of 6 weeks.
The core stability program consists of the following exercises:
1. Level I: weeks 1-2 - easy strengthening exercises:
1.1. Supine abdominal draw-in with single knee to chest, with heel slide and with double knee to chest:
1.1.1. Supine twist
1.1.2. Prone bridging on elbow
1.1.3. Side bridging on elbow
1.1.4. Prone cobra
1.2. Supine glute lift with arm at side, across chest and with single leg lift
2. Level II: weeks 2-4 - medium strengthening exercises:
2.1. Abdominal draw-in with feet on medicine ball and with feet on ball with movement added:
2.1.1. Supine dead bugs
2.1.2. Rolling like a ball
2.1.3. Prone bridging on elbows with single leg hip extension
2.1.4. Side bridging on elbows with single leg hip abduction
2.1.5. Quadruped opposite arm/leg raise (can add weight or dumbbell)
2.1.6. Abdominal crunches on physioball
2.1.7. Abdominal crunches on physioball with rotation
2.1.8 Bridging with head on physioball
3. Level III: weeks 4-6 - difficult strengthening exercises:
3.1. Prone bridging "around the world"
3.2. Side bridging - hip abduction, followed by flexion, followed by extension movements
3.3. Seated Russian twist with medicine ball
The supervised program (Group I) consists of three levels, each of which is 2 weeks of selected exercises, and after completion, participants proceed to the next level. Each level involves 3 sessions per week with 2 sets of 10 repetitions and 10 seconds hold. Additionally, at the beginning of each session, participants will receive conventional low back pain treatment - hot packs and TENS.
Group II will receive one training session and be provided with written materials to enable them to complete the core stability exercises at home. They will be provided with a hot pack and will be guided to use a hot water bottle at home before the session. Group II participants will be called for further assessment after 4 weeks and after completion of the 6 week program.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
The following were assessed at the baseline and 6 weeks (end of the intervention):
1. Low back pain measured using Oswestry Disability Index (ODI) and Numeric Pain Rating Scale (NPRS)
2. Core stability assessed using the Core Stability Assessment Scale
Secondary outcome measures
Current secondary outcome measures as of 26/09/2018:
Range of motion, assessed using an incliometer at the baseline and 6 weeks (end of the intervention)
Previous secondary outcome measures:
Goniometry of lumbar spine, assessed using goniometer at the baseline and 6 weeks (end of the intervention)
Overall trial start date
01/02/2018
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Post C-section low back pain for a minimum of 2 months and maximum of 2 years
2. Aged 25-40 years
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
30
Participant exclusion criteria
Participants with other systemic, bone and soft tissue diseases including:
1. Lumbar spinal stenosis
2. Spondylosis
3. Spondylolisthesis
4. Lumbar radiculopathy
5. Spinal cord injury
6. Paraplegia
7. Fractures
8. Herniated lumbar disc
9. Scheuermann’s disease
10. Ankylosing spondylitis
11. Rheumatoid arthritis
12. Osteoporosis etc.
Recruitment start date
01/08/2018
Recruitment end date
30/09/2018
Locations
Countries of recruitment
Pakistan
Trial participating centre
Helping Hand for Relief and Development (HHRD) Comprehensive Rehabilitation Centre Chakwal
Govt. College Road
Chakwal
48800
Pakistan
Sponsor information
Organisation
Riphah International University
Sponsor details
Plot#50
St#5
Faiz Ahmad Faiz Road
Sector H-8/2
Islamabad
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
Results will be published in an international research journal
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Syed ShakeelurRehman (shakil.urrehman@riphah.edu.pk)
Intention to publish date
01/12/2018
Participant level data
Available on request
Basic results (scientific)
Publication list