Pelvic Girdle PainNCT04687787
Core Stabilization Versus Routine Routine Exercises in Pelvic Girdle Pain.
A study testing Core Stabilization exercises and Routinely prescribed exercises in people with Pelvic Girdle Pain, run by Riphah International University at 2 sites in Pakistan.
Trial summary
Pregnancy Induced Pelvic Girdle Pain (PGP) is common complaint in pregnant women all over the world and it has a major impact on health and functioning as it decreases quality of life. The onset of PGP is usually seen at 17-19 week of gestation, with a peak of incidence at 24- 36 weeks. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Pelvic Girdle Pain
- What is being tested?
- Core Stabilization exercises and Routinely prescribed exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jan 2021to 30 May 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women having Pelvic Girdle Pain in 2nd trimester or 1st month of third trimester.
- Age between 20-40 years.
- Positive FABER test (leg of patient is placed in figure of 4 and apply small amplitude oscillation are applied at end range of motion after stabilizing opposite side of Pelvis.
- Positive test elicits pain and limited ROM)
- Positive P4 test (leg of patient is flexed at 90 degrees in supine position. Sacrum is stabilized by one hand and axial pressure is applied along the femur by other hand.
- Positive test elicits pain in SI joint).
Who cannot join
- History of Pelvic Fractures and Surgery
- History of metabolic diseases.
- Radiculopathy
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Alam Family Hospital
Rawalpindi, Punjab Province, 44000
Izzat Ali Shah Hospital
Rawalpindi, Punjab Province, 44000
About this study
Official title: Comparison of Core Stabilization Exercises and Routine Exercise Therapy on Pregnancy Induced Pelvic Girdle Pain
Pregnancy Induced Pelvic Girdle Pain (PGP) is common complaint in pregnant women all over the world and it has a major impact on health and functioning as it decreases quality of life. The onset of PGP is usually seen at 17-19 week of gestation, with a peak of incidence at 24- 36 weeks. The purpose of this study is to compare the effects of stabilization exercises on pregnancy induced pelvic girdle pain and its effects on the activity levels as compare to the physiotherapy exercises that are routinely prescribed
Read the detailed description
the study is Randomized Controlled trial which will be conducted in the Outpatient Physical therapy Department. Patient with suspected PGP will be referred by midwives, physicians or directly contact to Physiotherapist. Sample size of 30 individual was calculated by using open Epi tool with 95% confidence Interval (CI) and 80% Power. Inclusion criteria for patients is 13-28 gestational weeks determined by special test include P4 Test (Posterior Pelvic Pain Provocation) and FABER test (Flexion Abduction and External Rotation). Individuals would be randomly allocated into two groups by sealed envelope method.
Assessment will be done at base line and 4th week by using NPRS and PGP Questionnaire. Data will be analyzed by using SPSS version 21.
- Conditions
- Pelvic Girdle Pain
- Being tested
- Core Stabilization exercises, Routinely prescribed exercises
- Keywords
- Core Stability Exercises, Pelvic Girdle Pain, Pregnancy, Physical therapy management
- Medical subject headings
- Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stabilization exercisesOther
. Each session will be given for 40 mins (20 mins for TENS and 20 Mins for exercise) Core Stability Exercises include Kegel Exercises, Modified V-sit, opposite Arm Leg Raise, Seated Side bends poses, Dumbell Side bends and Pelvic Tilt. Participants will perform 1 set of exercise having 10 repetitions with hold of 5 seconds. Session would be performed thrice a week.
Routinely prescribed exercisesOther
Each session will be given for 40 mins ( 20 mins for TENS and 20 Mins for exercise Routinely prescribed exercises composed of Hamstring stretches, hip flexor stretches, hip extensor stretches, calf stretches, and back extensor stretches. Participants will perform 1 set of exercise having 10 repetitions with hold of 5 seconds. Session would be performed thrice a week.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | This group will receive Core Stability Exercises with Application of TENS Receives: Other: Core Stabilization exercises |
| Group II | Active comparator | This group will receive Routinely prescribed Exercises with application of TENS Receives: Other: Routinely prescribed exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Measured: Baseline
Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Measured: Post 4 week
Pelvic Girdle Pain Questionnaire (PGPQ)
The Pelvic Girdle Questionnaire (PG Q) is a condition-specific measure for women with pelvic girdle pain (PGP). The questionnaire has 25 items under two sub-scales (20 items for activates and 5 items for symptoms), with percentage scores that range from 0 (no disability) to 100 (great disability).
Measured: Baseline
Pelvic Girdle Pain Questionnaire (PGPQ)
The Pelvic Girdle Questionnaire (PG Q) is a condition-specific measure for women with pelvic girdle pain (PGP). The questionnaire has 25 items under two sub-scales (20 items for activates and 5 items for symptoms), with percentage scores that range from 0 (no disability) to 100 (great disability).
Measured: Post 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Jan 2021
- Primary completion15 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pelvic Girdle 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
- Model description
- There will be two groups which will receive physical therapy interventions. one will be experimental and other will be control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687787
- Sponsor's protocol ID
- Rec/00837 Zahra Ejaz
- Status last verified
- Jun 2021
- First submitted
- 25 Dec 2020
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almousa S, Lamprianidou E, Kitsoulis G. The effectiveness of stabilising exercises in pelvic girdle pain during pregnancy and after delivery: A systematic review. Physiother Res Int. 2018 Jan;23(1). doi: 10.1002/pri.1699. Epub 2017 Nov 8.
PubMed 29115735Walters C, West S, A Nippita T. Pelvic girdle pain in pregnancy. Aust J Gen Pract. 2018 Jul;47(7):439-443. doi: 10.31128/AJGP-01-18-4467.
PubMed 30114872Timothy J. Piper EJ, Mike Haiduke, Mike Waller, and Cathy McMillan. Core Training Exercise Selection During Pregnancy. Strength and Condtioning Journal. 2012;34(1).
Saleh MSM, Botla AMM, Elbehary NAM. Effect of core stability exercises on postpartum lumbopelvic pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(2):205-213. doi: 10.3233/BMR-181259.
PubMed 30282349Akhtar MW, Karimi H, Gilani SA. Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial. Pak J Med Sci. 2017 Jul-Aug;33(4):1002-1006. doi: 10.12669/pjms.334.12664.
PubMed 29067082
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Core Stabilization Exercises and Routine Exercise Therapy on Pregnancy Induced Pelvic Girdle Pain
- ClinicalTrials.gov ID
- NCT04687787
- Acronym / sponsor ID
- Rec/00837 Zahra Ejaz
- Conditions
- Pelvic Girdle Pain
- Keywords
- Core Stability Exercises, Pelvic Girdle Pain, Pregnancy, Physical therapy management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 29 Dec 2020 (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.
Pregnancy Induced Pelvic Girdle Pain (PGP) is common complaint in pregnant women all over the world and it has a major impact on health and functioning as it decreases quality of life. The onset of PGP is usually seen at 17-19 week of gestation, with a peak of incidence at 24- 36 weeks. The purpose of this study is to compare the effects of stabilization exercises on pregnancy induced pelvic girdle pain and its effects on the activity levels as compare to the physiotherapy exercises that are routinely prescribed
Detailed description
the study is Randomized Controlled trial which will be conducted in the Outpatient Physical therapy Department. Patient with suspected PGP will be referred by midwives, physicians or directly contact to Physiotherapist. Sample size of 30 individual was calculated by using open Epi tool with 95% confidence Interval (CI) and 80% Power. Inclusion criteria for patients is 13-28 gestational weeks determined by special test include P4 Test (Posterior Pelvic Pain Provocation) and FABER test (Flexion Abduction and External Rotation). Individuals would be randomly allocated into two groups by sealed envelope method.
Assessment will be done at base line and 4th week by using NPRS and PGP Questionnaire. Data will be analyzed by using SPSS version 21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There will be two groups which will receive physical therapy interventions. one will be experimental and other will be control group.
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Core Stabilization exercisesThis group will receive Core Stability Exercises with Application of TENS |
| Group II | Active comparator | Other: Routinely prescribed exercisesThis group will receive Routinely prescribed Exercises with application of TENS |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women having Pelvic Girdle Pain in 2nd trimester or 1st month of third trimester.
- Age between 20-40 years.
- Positive FABER test (leg of patient is placed in figure of 4 and apply small amplitude oscillation are applied at end range of motion after stabilizing opposite side of Pelvis.
- Positive test elicits pain and limited ROM)
- Positive P4 test (leg of patient is flexed at 90 degrees in supine position. Sacrum is stabilized by one hand and axial pressure is applied along the femur by other hand.
Key exclusion criteria (3 listed)
- History of Pelvic Fractures and Surgery
- History of metabolic diseases.
- Radiculopathy
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 Stabilization exercises. Each session will be given for 40 mins (20 mins for TENS and 20 Mins for exercise) Core Stability Exercises include Kegel Exercises, Modified V-sit, opposite Arm Leg Raise, Seated Side bends poses, Dumbell Side bends and Pelvic Tilt. Participants will perform 1 set of exercise having 10 repetitions with hold of 5 seconds. Session would be performed thrice a week. | Other | Group I |
| Routinely prescribed exercisesEach session will be given for 40 mins ( 20 mins for TENS and 20 Mins for exercise Routinely prescribed exercises composed of Hamstring stretches, hip flexor stretches, hip extensor stretches, calf stretches, and back extensor stretches. Participants will perform 1 set of exercise having 10 repetitions with hold of 5 seconds. Session would be performed thrice a week. | Other | Group II |
Primary outcome
Numeric pain rating scale (NPRS)
Time frame: Baseline
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Numeric pain rating scale (NPRS)
Time frame: Post 4 week
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Pelvic Girdle Pain Questionnaire (PGPQ)
Time frame: Baseline
The Pelvic Girdle Questionnaire (PG Q) is a condition-specific measure for women with pelvic girdle pain (PGP). The questionnaire has 25 items under two sub-scales (20 items for activates and 5 items for symptoms), with percentage scores that range from 0 (no disability) to 100 (great disability).
Pelvic Girdle Pain Questionnaire (PGPQ)
Time frame: Post 4 weeks
The Pelvic Girdle Questionnaire (PG Q) is a condition-specific measure for women with pelvic girdle pain (PGP). The questionnaire has 25 items under two sub-scales (20 items for activates and 5 items for symptoms), with percentage scores that range from 0 (no disability) to 100 (great disability).
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 Jun 2021.
- Background: PubMed 29115735Almousa S, Lamprianidou E, Kitsoulis G. The effectiveness of stabilising exercises in pelvic girdle pain during pregnancy and after delivery: A systematic review. Physiother Res Int. 2018 Jan;23(1). doi: 10.1002/pri.1699. Epub 2017 Nov 8.
- Background: PubMed 30114872Walters C, West S, A Nippita T. Pelvic girdle pain in pregnancy. Aust J Gen Pract. 2018 Jul;47(7):439-443. doi: 10.31128/AJGP-01-18-4467.
- BackgroundTimothy J. Piper EJ, Mike Haiduke, Mike Waller, and Cathy McMillan. Core Training Exercise Selection During Pregnancy. Strength and Condtioning Journal. 2012;34(1).
- Background: PubMed 30282349Saleh MSM, Botla AMM, Elbehary NAM. Effect of core stability exercises on postpartum lumbopelvic pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(2):205-213. doi: 10.3233/BMR-181259.
- Background: PubMed 29067082Akhtar MW, Karimi H, Gilani SA. Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial. Pak J Med Sci. 2017 Jul-Aug;33(4):1002-1006. doi: 10.12669/pjms.334.12664.
- 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 principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Stabilization exercises and Routinely prescribed exercises in people with Pelvic Girdle Pain, run by Riphah International University at 2 sites 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 6 inclusion and 3 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 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Numeric pain rating scale (NPRS) (time frame: Baseline). 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 NCT04687787, which also lists 5 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 Jun 2021.