Low Back PainNCT06303258
Generalized Versus Core Stabilization Antenatal Exercises For Lumbopelvic Pain
A study testing Core Stabalization Exercises and Generalized Antenatal Exercises in people with Low Back Pain and Pelvic Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Core stability training has gained popularity as a fitness trend and is now being used in rehabilitation programs as well the patient adherence to this intervention has been low due to its complex nature, particularly pregnant females .Limited literature is available to present the effect of core stabilization… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Pelvic Pain
- What is being tested?
- Core Stabalization Exercises and Generalized Antenatal Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Mar 2024to 30 Jun 2024
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 2nd Trimester of Pregnancy
- Multigravida
- Patients having Lumbopelvic pain
- Working women and housewives
Who cannot join
- Hx of Metabolic Disease
- Hx of Pelvic Fracture and Surgery
- Radiculopathy
- Participants with absolute contraindications for the exercise
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Tehsil Headquarter Hospital Raiwind
Lahore, Punjab Province, 55150
About this study
Official title: Comparison of Generalized Versus Core Stabilization Antenatal Exercises For Lumbopelvic Pain In Pregnancy
Core stability training has gained popularity as a fitness trend and is now being used in rehabilitation programs as well the patient adherence to this intervention has been low due to its complex nature, particularly pregnant females .Limited literature is available to present the effect of core stabilization exercises in comparison to the other handful simplified techniques and exercises This study compares two interventions for this particular condition to identify a feasible and enjoyable therapeutic intervention for the pregnant women who suffer Lumbopelvic Pain.
Read the detailed description
This is a randomized control trial to compare the effects of core stabilization versus generalized antenatal exercises for lumbopelvic pain in pregnant women. Females meeting the inclusion and exclusion criteria will be divided into three groups by convenient sampling technique. A sample size of 48 females with 16 females in each group. Group A will be treated by core stability exercises and group B will be treated by generalized antenatal exercises and group C will receive basic antenatal education. Group A and B will have three treatment sessions per week for 4 weeks. Females will be evaluated at baseline and 2nd and 4th week . Females will be screened by Patricks faber test, piriformis /FAIR test, p4/posterior pelvic pain provocation test and assessed by visual analogue scale (VAS) and pregnant women quality of life questionnaire (QOL- GRAV).
- Conditions
- Low Back Pain, Pelvic Pain
- Being tested
- Core Stabalization Exercises, Generalized Antenatal Exercises
- Medical subject headings
- Low Back Pain, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stabalization ExercisesOther
Low Intensity Warm Up Exercises Core Stabilization Exercises Cool Down Stretching Exercises
Generalized Antenatal ExercisesOther
Low Intensity WarmUp Exercise Aerobic Training Endurance Training Pelvic Floor Muscle Training Cool Down Stretching Exercises
| Study group | Role | What they receive |
|---|---|---|
| Core Stabalization Exercises Group | Experimental | This Group will receive core stability exercises 3 sessions per week for 4 weeks and basic antenatal education. Receives: Other: Core Stabalization Exercises |
| Generalized Exercise Group | Experimental | This Group will receive generalized supervised antenatal exercises that are covered in three phases and basic antenatal education. There will be 3 sessions per week for 10weeks conducted for generalized antenatal exercises including Aerobics, Endurance and Pelvic Floor Muscle Training. Receives: Other: Generalized Antenatal Exercises |
| Control Group | No intervention | Basic Antenatal Education for Lumbopelvic Pain Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients
Measured: Changes from Baseline to 2nd week
Visual Analogue Scale (VAS)
It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients
Measured: Changes from 2nd week to 4th week
Pregnant women's quality of life questionnaire (QOL-GRAV)
Nine items make up the scale that allows individuals to describe their individual experiences with pregnancy's quality of life. It had a greater internal consistency than 0.7. A 5-point Likert scale (ranging from not at all [0] to totally [4]) was used to rate each item. The final three questions-7, 8 and 9-are scored in reverse.
Measured: Changes from Baseline to 2nd week
Pregnant women's quality of life questionnaire (QOL-GRAV)
Nine items make up the scale that allows individuals to describe their individual experiences with pregnancy's quality of life. It had a greater internal consistency than 0.7. A 5-point Likert scale (ranging from not at all [0] to totally [4]) was used to rate each item. The final three questions-7, 8 and 9-are scored in reverse.
Measured: Changes from 2nd week to 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start4 Mar 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PHD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303258
- Sponsor's protocol ID
- RiphahIU Sharmeen Kanwar
- Status last verified
- Jul 2024
- First submitted
- 4 Mar 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sklempe Kokic I, Ivanisevic M, Uremovic M, Kokic T, Pisot R, Simunic B. Effect of therapeutic exercises on pregnancy-related low back pain and pelvic girdle pain: Secondary analysis of a randomized controlled trial. J Rehabil Med. 2017 Mar 6;49(3):251-257. doi: 10.2340/16501977-2196.
PubMed 28233012Stuge B. Evidence of stabilizing exercises for low back- and pelvic girdle pain - a critical review. Braz J Phys Ther. 2019 Mar-Apr;23(2):181-186. doi: 10.1016/j.bjpt.2018.11.006. Epub 2018 Nov 17.
PubMed 30471967Varela-Esquivias A, Diaz-Martinez L, Avendano-Badillo D. [Efficacy of lumbopelvic stabilization exercises in patients with lumbalgia]. Acta Ortop Mex. 2020 Jan-Feb;34(1):10-15. Spanish.
PubMed 33230993Leonard JH, Paungmali A, Sitilertpisan P, Pirunsan U, Uthaikhup S. Changes in Transversus Abdominis Muscle Thickness after Lumbo-Pelvic Core Stabilization Training among Chronic Low Back Pain Individuals. Clin Ter. 2015;166(5):e312-6. doi: 10.7417/T.2015.1884.
PubMed 26550815
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Generalized Versus Core Stabilization Antenatal Exercises For Lumbopelvic Pain In Pregnancy
- ClinicalTrials.gov ID
- NCT06303258
- Acronym / sponsor ID
- RiphahIU Sharmeen Kanwar
- Conditions
- Low Back Pain, Pelvic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 Mar 2024 (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.
Core stability training has gained popularity as a fitness trend and is now being used in rehabilitation programs as well the patient adherence to this intervention has been low due to its complex nature, particularly pregnant females .Limited literature is available to present the effect of core stabilization exercises in comparison to the other handful simplified techniques and exercises This study compares two interventions for this particular condition to identify a feasible and enjoyable therapeutic intervention for the pregnant women who suffer Lumbopelvic Pain.
Detailed description
This is a randomized control trial to compare the effects of core stabilization versus generalized antenatal exercises for lumbopelvic pain in pregnant women. Females meeting the inclusion and exclusion criteria will be divided into three groups by convenient sampling technique. A sample size of 48 females with 16 females in each group. Group A will be treated by core stability exercises and group B will be treated by generalized antenatal exercises and group C will receive basic antenatal education. Group A and B will have three treatment sessions per week for 4 weeks. Females will be evaluated at baseline and 2nd and 4th week . Females will be screened by Patricks faber test, piriformis /FAIR test, p4/posterior pelvic pain provocation test and assessed by visual analogue scale (VAS) and pregnant women quality of life questionnaire (QOL- GRAV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Core Stabalization Exercises Group | Experimental | Other: Core Stabalization ExercisesThis Group will receive core stability exercises 3 sessions per week for 4 weeks and basic antenatal education. |
| Generalized Exercise Group | Experimental | Other: Generalized Antenatal ExercisesThis Group will receive generalized supervised antenatal exercises that are covered in three phases and basic antenatal education. There will be 3 sessions per week for 10weeks conducted for generalized antenatal exercises including Aerobics, Endurance and Pelvic Floor Muscle Training. |
| Control Group | No intervention | –Basic Antenatal Education for Lumbopelvic Pain Prevention |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 2nd Trimester of Pregnancy
- Multigravida
- Patients having Lumbopelvic pain
- Working women and housewives
Key exclusion criteria (4 listed)
- Hx of Metabolic Disease
- Hx of Pelvic Fracture and Surgery
- Radiculopathy
- Participants with absolute contraindications for the exercise
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 |
|---|---|---|
| Core Stabalization ExercisesLow Intensity Warm Up Exercises Core Stabilization Exercises Cool Down Stretching Exercises | Other | Core Stabalization Exercises Group |
| Generalized Antenatal ExercisesLow Intensity WarmUp Exercise Aerobic Training Endurance Training Pelvic Floor Muscle Training Cool Down Stretching Exercises | Other | Generalized Exercise Group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: Changes from Baseline to 2nd week
It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients
Visual Analogue Scale (VAS)
Time frame: Changes from 2nd week to 4th week
It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients
Pregnant women's quality of life questionnaire (QOL-GRAV)
Time frame: Changes from Baseline to 2nd week
Nine items make up the scale that allows individuals to describe their individual experiences with pregnancy's quality of life. It had a greater internal consistency than 0.7. A 5-point Likert scale (ranging from not at all [0] to totally [4]) was used to rate each item. The final three questions-7, 8 and 9-are scored in reverse.
Pregnant women's quality of life questionnaire (QOL-GRAV)
Time frame: Changes from 2nd week to 4th week
Nine items make up the scale that allows individuals to describe their individual experiences with pregnancy's quality of life. It had a greater internal consistency than 0.7. A 5-point Likert scale (ranging from not at all [0] to totally [4]) was used to rate each item. The final three questions-7, 8 and 9-are scored in reverse.
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 16 Jul 2024.
- Background: PubMed 28233012Sklempe Kokic I, Ivanisevic M, Uremovic M, Kokic T, Pisot R, Simunic B. Effect of therapeutic exercises on pregnancy-related low back pain and pelvic girdle pain: Secondary analysis of a randomized controlled trial. J Rehabil Med. 2017 Mar 6;49(3):251-257. doi: 10.2340/16501977-2196.
- Background: PubMed 30471967Stuge B. Evidence of stabilizing exercises for low back- and pelvic girdle pain - a critical review. Braz J Phys Ther. 2019 Mar-Apr;23(2):181-186. doi: 10.1016/j.bjpt.2018.11.006. Epub 2018 Nov 17.
- Background: PubMed 33230993Varela-Esquivias A, Diaz-Martinez L, Avendano-Badillo D. [Efficacy of lumbopelvic stabilization exercises in patients with lumbalgia]. Acta Ortop Mex. 2020 Jan-Feb;34(1):10-15. Spanish.
- Background: PubMed 26550815Leonard JH, Paungmali A, Sitilertpisan P, Pirunsan U, Uthaikhup S. Changes in Transversus Abdominis Muscle Thickness after Lumbo-Pelvic Core Stabilization Training among Chronic Low Back Pain Individuals. Clin Ter. 2015;166(5):e312-6. doi: 10.7417/T.2015.1884.
- 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.
Huma Riaz, PHD 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 Core Stabalization Exercises and Generalized Antenatal Exercises in people with Low Back Pain and 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 4 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 16 Jul 2024. 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 (VAS) (time frame: Changes from Baseline to 2nd week). The study lists 4 primary outcomes in all. 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 NCT06303258, which also lists 4 linked publications.
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 16 Jul 2024.