The effects of a static exercise program versus Swiss ball training for core muscles of the lower back and pelvic region in patients with low back pain after child delivery
| ISRCTN | ISRCTN14142103 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14142103 |
- Submission date
- 11/07/2018
- Registration date
- 10/08/2018
- Last edited
- 07/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Public
Riphah College of Rehabilitation Sciences, 274, main Peshawar road
Rawalpindi
46000
United Arab Emirates
 ORCID ID |
0000-0002-6682-9896 |
|---|---|
| Phone | +923207866611 |
| shakil.urrehman@riphah.edu.pk |
Study information
| Study design | Interventional randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN14142103_PIS.docx |
| Scientific title | Effects of Static Core Muscles Stability Exercise versus Swiss ball training program in patients with post-partum low back pain |
| Study objectives | There will be a difference in the effects of the static exercise program and Swiss ball training in postpartum low back pain |
| Ethics approval(s) | Research Ethical Committee, Riphah College of Rehabilitation Sciences Riphah International University, Islamabad, 20/03/2018, Riphah/RCRS/REC/00294 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2018 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Aged 25-35 years 2. Postpartum back pain for period of 2-8 months 3. Normal delivery during birth |
| Key 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 |
| Date of first enrolment | 15/08/2018 |
| Date of final enrolment | 31/10/2018 |
Locations
Countries of recruitment
- Pakistan
Study participating centre
Rawalpindi
46000
Pakistan
Sponsor information
University/education
Riphah College of Rehabilitation Sciences, plot # 50, street #5 , H-8/2 Islamabad
Islamabad, pakistan
44000
Pakistan
| Phone | +923207866611 |
|---|---|
| shakil.urrehman@riphah.edu.pk | |
"ROR" |
https://ror.org/02kdm5630 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high impact peer reviewed journal |
| IPD sharing plan | 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 02/04/2019 | No | Yes |
Additional files
- ISRCTN14142103_PIS.docx
- Uploaded 02/04/2019
Editorial Notes
07/11/2019: Internal review.
02/04/2019: The participant information sheet has been uploaded.
13/11/2018: The recruitment end date was changed from 15/10/2018 to 31/10/2018.
26/09/2018: The following changes have been made to the trial record:
1. In the interventions, "flexion and extension ranges will be measured using a goniometer" has been changed to "flexion and extension ranges will be measured using an inclinometer".
2. The secondary outcome measures have been updated
10/08/2018: The following changes have been made to the trial record:
1. The recruitment start date has been changed from 01/08/2018 to 15/08/2018
2. The recruitment end date has been changed from 15/08/2018 to 15/10/2018
