Condition category
Musculoskeletal Diseases
Date applied
11/07/2018
Date assigned
10/08/2018
Last edited
26/09/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

No participant information sheet available

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

15/10/2018

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

Editorial Notes

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