Back PainNCT05342181
Static and Dynamic Core Stability Exercises in Potpartum Back Pain
A study testing Static exercises and Dynamic exercises in people with Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of static exercises with dynamic core stability on pain and disability in postpartum back pain. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Back Pain
- What is being tested?
- Static exercises and Dynamic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Sep 2021to 14 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age groups of 18 to 35
- Pain more than 4/10 on VAS
- Without referred pain to lower limbs
- Women with normal delivery
Who cannot join
- Nulliparous women
- Osteoporosis and OA
- Systemic arterial hypertension
- Hypersensitivity to electrical modalities
- Any fracture (spine, rib) or injury
- Any abdominal surgery
- Any other general ailment
- Vertebral or disc pathologies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Static and Dynamic Core Stability Exercises on Pain and Disability in Postpartum Back Pain
To compare the effects of static exercises with dynamic core stability on pain and disability in postpartum back pain.
Read the detailed description
The study comprised 28 participants. The individuals were subdivided into binary groups, group A performed static exercises and group B performed dynamic exercises including swiss ball, each containing 14 subjects. Baseline treatment (Hot pack, TENS and posture correction) to both groups was given along with core stability exercises. Core stability exercises were performed on both group for 4 weeks. The pretreatment and post treatment tests are measured using the scale VAS (visual analog scale) and Oswestry disability index questionnaire. Both groups have shown the improvement in postpartum lumber pain and an improved in daily life activities. But swiss ball exercises have more significant improvement on pain and disability in patients having postpartum lumber pain.
- Conditions
- Back Pain
- Being tested
- Static exercises, Dynamic exercises
- Keywords
- Pain and disability in postpartum
- Medical subject headings
- Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static exercisesOther
Participants will be treated with static core muscle exercises that are traditional group of exercises :
- supine bridge
- plank
- oblique crunch
- side lying with Abduction
This program includes static exercises performed thrice a week for 4 weeks.This exercise comprises 5 minutes warm up and slight stretching.Rest time of 2-3 minutes with proper stretching in between sets of activity. Subjects will be requested to undertake cool down exercises, which include aerobic workouts followed by stretching exercises, at the end of each day's exercise programme. Before beginning the next session's training, the subjects will be asked if they had any discomfort.
Dynamic exercisesOther
Participants will be treated with dynamic core muscle exercises that were swiss ball exercises
- bridging
- straight leg raise in prone lying
- straight leg raise with hand raise in prone lying
- pelvic tilts
This program includes static exercises performed thrice a week for 4 weeks.This exercise comprises 5 minutes warm up and slight stretching.Rest time of 2-3 minutes with proper stretching in between sets of activity. Subjects will be requested to undertake cool down exercises, which include aerobic workouts followed by stretching exercises, at the end of each day's exercise programme. Before beginning the next session's training, the subjects will be asked if they had any discomfort.
| Study group | Role | What they receive |
|---|---|---|
| Static exercises | Experimental | static exercises i.e traditional exercises along with base line treatment of TENS and hot pack Receives: Other: Static exercises |
| Dynamic exercises | Experimental | dynamic (Swiss ball) exercises along with base line treatment of TENS and hot pack Receives: Other: Dynamic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry disability index
Oswestry disability index (ODI) is used to measure disability. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Measured: 4th week
visual analog scale
Visual analog scale (VAS) is usd to measure pain intensity. The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start21 Sep 2021
- Primary completion25 Oct 2021
- Study completion14 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Aabroo, pp-dpt, Principal investigator, General hospital lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342181
- Sponsor's protocol ID
- RiphahIU Saba Amjad
- Status last verified
- Apr 2022
- First submitted
- 20 Feb 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Static and Dynamic Core Stability Exercises on Pain and Disability in Postpartum Back Pain
- ClinicalTrials.gov ID
- NCT05342181
- Acronym / sponsor ID
- RiphahIU Saba Amjad
- Conditions
- Back Pain
- Keywords
- Pain and disability in postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 14 Nov 2021 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effects of static exercises with dynamic core stability on pain and disability in postpartum back pain.
Detailed description
The study comprised 28 participants. The individuals were subdivided into binary groups, group A performed static exercises and group B performed dynamic exercises including swiss ball, each containing 14 subjects. Baseline treatment (Hot pack, TENS and posture correction) to both groups was given along with core stability exercises. Core stability exercises were performed on both group for 4 weeks. The pretreatment and post treatment tests are measured using the scale VAS (visual analog scale) and Oswestry disability index questionnaire. Both groups have shown the improvement in postpartum lumber pain and an improved in daily life activities. But swiss ball exercises have more significant improvement on pain and disability in patients having postpartum lumber pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Static exercises | Experimental | Other: Static exercisesstatic exercises i.e traditional exercises along with base line treatment of TENS and hot pack |
| Dynamic exercises | Experimental | Other: Dynamic exercisesdynamic (Swiss ball) exercises along with base line treatment of TENS and hot pack |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age groups of 18 to 35
- Pain more than 4/10 on VAS
- Without referred pain to lower limbs
- Women with normal delivery
Key exclusion criteria (8 listed)
- Nulliparous women
- Osteoporosis and OA
- Systemic arterial hypertension
- Hypersensitivity to electrical modalities
- Any fracture (spine, rib) or injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static exercisesParticipants will be treated with static core muscle exercises that are traditional group of exercises : 1. supine bridge 2. plank 3. oblique crunch 4. side lying with Abduction This program includes static exercises performed thrice a week for 4 weeks.This exercise comprises 5 minutes warm up and slight stretching.Rest time of 2-3 minutes with proper stretching in between sets of activity. Subjects will be requested to undertake cool down exercises, which include aerobic workouts followed by stretching exercises, at the end of each day's exercise programme. Before beginning the next session's training, the subjects will be asked if they had any discomfort. | Other | Static exercises |
| Dynamic exercisesParticipants will be treated with dynamic core muscle exercises that were swiss ball exercises 1. bridging 2. straight leg raise in prone lying 3. straight leg raise with hand raise in prone lying 4. pelvic tilts This program includes static exercises performed thrice a week for 4 weeks.This exercise comprises 5 minutes warm up and slight stretching.Rest time of 2-3 minutes with proper stretching in between sets of activity. Subjects will be requested to undertake cool down exercises, which include aerobic workouts followed by stretching exercises, at the end of each day's exercise programme. Before beginning the next session's training, the subjects will be asked if they had any discomfort. | Other | Dynamic exercises |
Primary outcome
Oswestry disability index
Time frame: 4th week
Oswestry disability index (ODI) is used to measure disability. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
visual analog scale
Time frame: 4th week
Visual analog scale (VAS) is usd to measure pain intensity. The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Aabroo, pp-dpt principal investigator
General hospital lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static exercises and Dynamic exercises in people with Back Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry disability index (time frame: 4th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.