Pelvic PainLPPNCT05490810
Effects of Trunk Stabilization Versus Activation Exercises on Pain and Disability in Postpartum Lumbo-pelvic Pain
A study testing Trunk stabilization and Activation exercises in people with Pelvic Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the Effects of trunk stabilization versus activation exercises on pain and disability in postpartum lumbo-pelvic pain. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- Trunk stabilization and Activation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2022to 30 Jul 2022
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-40
- Female after postpartum
- Two or more positive posterior provocation test
- Active straight leg raises
- Pain onset during pregnancy
Who cannot join
- Orthopedic or rheumatologic disorders
- Intervertebral disc pathology
- Neoplasm or previuos surgery of spine
- History of fracture.
Trial locations and contacts
1 site in 1 country.
About this study
To compare the Effects of trunk stabilization versus activation exercises on pain and disability in postpartum lumbo-pelvic pain.
Read the detailed description
Effects of stabilizing exercises on postpartum pelvic floor muscle function, lumbo-pelvic pain and disability. In results, stability exercises can help women with LPP enhance the function of their PFMs. Pregnancy and childbirth weakens PFMs and disrupts the load-transfer system in the lumbo-pelvic area. The use of PFMs in the right pattern can help these muscles operate better. Local stabilizing muscles are targeted during stabilization exercises, which increase pelvic motor control and stability.
As per researcher knowledge there was limited evidence present on the comparison of trunk stabilization and trunk activation exercises. Therefore, this study was conducted to find the effectiveness of trunk stabilization versus activation exercises on disability and pain in postpartum women with lumbo-pelvic pain.
- Conditions
- Pelvic Pain
- Being tested
- Trunk stabilization, Activation exercises
- Keywords
- Lumbo-pelvic Pain, Postpartum, Stabilization Exercises, Trunk Activation Exercises
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk stabilizationOther
Trunk stabilization exercises with
- Static back: A roll of towel was pressed against the back and the position was held for 10 secs and then released
- Static gluteus: The gluts were pressed inside and hold for 10 secs and then released.
- Abdominal bracing: Brace your abdomen by contracting your entire abdomen. From here Perform different exercises such as raising your arms and then raising your legs.
- Pelvic bridging: In crook lying, engage your gluts and trunk lift your hips towards the ceiling. Hold the position for 10 secs and then release.
- SLR with-hold at 30 and 45 degrees: Ask the supine patient to raise the leg up-to 45 degrees and hold for 10 secs. Then raise the leg up-to 30 degrees then hold for 10 secs.
Activation exercisesOther
Activation exercises with
- Upper rectus abdominis (URA) and lower rectus abdominis (LRA): body supine with hips and knees flexed 90°, with feet locked. Participants flexed the trunk (i.e. crunch execution) against resistance at the level of the shoulders..
- External oblique (EO) and internal oblique (IO): side-lying with the hip at the edge of the bench and feet locked by a second operator. Participants performed side-bend exercise against resistance at the level of the shoulder.
- Lower erector spinae (LES) and upper erector spinae (UES): prone position with ASIS at the edge of the bench and feet locked by a second operator. Participants performed a back extension against resistance at the level of the shoulders.
| Study group | Role | What they receive |
|---|---|---|
| Trunk stabilization | Experimental | Trunk stabilization exercises were given three times a week for two weeks. Receives: Other: Trunk stabilization |
| Activation exercises | Experimental | Activation exercises exercises performed twice for 5s, with 2 min rest between them for three times a week for two weeks. Receives: Other: Activation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
Pain intensity was assessed using a visual analog scale (VAS), which is a 100-mm ungraded line with two anchors. Its left and right anchors represented the minimum and maximum intensities of pain, respectively. The participants were asked to report their current pain intensity on the VAS.
Measured: 2 weeks
Secondary outcomes (1)
Oswestry disability index
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Feb 2022
- Primary completion29 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Neelam Muneeb, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490810
- Sponsor's protocol ID
- REC/RCR&AHS/22/0517
- Acronym
- LPP
- Status last verified
- Dec 2022
- First submitted
- 4 Aug 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chaudhry RY, Muneeb HN, Amjad A, Shafique S, Naseem A, Shahzadi N. Comparing the effects of trunk stabilisation and activation exercises on pain and disability in postpartum lumbo-pelvic pain: A randomised controlled trial. J Pak Med Assoc. 2024 Jan;74(1):126-128. doi: 10.47391/JPMA.8395.
PubMed 38219179
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Trunk Stabilization Versus Activation Exercises on Pain and Disability in Postpartum Lumbo-pelvic Pain
- ClinicalTrials.gov ID
- NCT05490810
- Acronym / sponsor ID
- LPP / REC/RCR&AHS/22/0517
- Conditions
- Pelvic Pain
- Keywords
- Lumbo-pelvic Pain, Postpartum, Stabilization Exercises, Trunk Activation Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 8 Aug 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 trunk stabilization versus activation exercises on pain and disability in postpartum lumbo-pelvic pain.
Detailed description
Effects of stabilizing exercises on postpartum pelvic floor muscle function, lumbo-pelvic pain and disability. In results, stability exercises can help women with LPP enhance the function of their PFMs. Pregnancy and childbirth weakens PFMs and disrupts the load-transfer system in the lumbo-pelvic area. The use of PFMs in the right pattern can help these muscles operate better. Local stabilizing muscles are targeted during stabilization exercises, which increase pelvic motor control and stability.
As per researcher knowledge there was limited evidence present on the comparison of trunk stabilization and trunk activation exercises. Therefore, this study was conducted to find the effectiveness of trunk stabilization versus activation exercises on disability and pain in postpartum women with lumbo-pelvic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trunk stabilization | Experimental | Other: Trunk stabilizationTrunk stabilization exercises were given three times a week for two weeks. |
| Activation exercises | Experimental | Other: Activation exercisesActivation exercises exercises performed twice for 5s, with 2 min rest between them for three times a week for two weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 20-40
- Female after postpartum
- Two or more positive posterior provocation test
- Active straight leg raises
- Pain onset during pregnancy
Key exclusion criteria (4 listed)
- Orthopedic or rheumatologic disorders
- Intervertebral disc pathology
- Neoplasm or previuos surgery of spine
- History of fracture.
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 |
|---|---|---|
| Trunk stabilizationTrunk stabilization exercises with * Static back: A roll of towel was pressed against the back and the position was held for 10 secs and then released * Static gluteus: The gluts were pressed inside and hold for 10 secs and then released. * Abdominal bracing: Brace your abdomen by contracting your entire abdomen. From here Perform different exercises such as raising your arms and then raising your legs. * Pelvic bridging: In crook lying, engage your gluts and trunk lift your hips towards the ceiling. Hold the position for 10 secs and then release. * SLR with-hold at 30 and 45 degrees: Ask the supine patient to raise the leg up-to 45 degrees and hold for 10 secs. Then raise the leg up-to 30 degrees then hold for 10 secs. | Other | Trunk stabilization |
| Activation exercisesActivation exercises with * Upper rectus abdominis (URA) and lower rectus abdominis (LRA): body supine with hips and knees flexed 90°, with feet locked. Participants flexed the trunk (i.e. crunch execution) against resistance at the level of the shoulders.. * External oblique (EO) and internal oblique (IO): side-lying with the hip at the edge of the bench and feet locked by a second operator. Participants performed side-bend exercise against resistance at the level of the shoulder. * Lower erector spinae (LES) and upper erector spinae (UES): prone position with ASIS at the edge of the bench and feet locked by a second operator. Participants performed a back extension against resistance at the level of the shoulders. | Other | Activation exercises |
Primary outcome
Visual analogue scale
Time frame: 2 weeks
Pain intensity was assessed using a visual analog scale (VAS), which is a 100-mm ungraded line with two anchors. Its left and right anchors represented the minimum and maximum intensities of pain, respectively. The participants were asked to report their current pain intensity on the VAS.
1 secondary outcome
Oswestry disability index
Time frame: 2 weeks
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 9 Dec 2022.
- Derived from this study: PubMed 38219179Chaudhry RY, Muneeb HN, Amjad A, Shafique S, Naseem A, Shahzadi N. Comparing the effects of trunk stabilisation and activation exercises on pain and disability in postpartum lumbo-pelvic pain: A randomised controlled trial. J Pak Med Assoc. 2024 Jan;74(1):126-128. doi: 10.47391/JPMA.8395.
- 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.
Hafiza Neelam Muneeb, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trunk stabilization and Activation exercises in people with Pelvic 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 5 inclusion and 4 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 9 Dec 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?
Visual analogue scale (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05490810, which also lists 1 linked publication.
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 9 Dec 2022.