Pregnancy Related Pelvic Girdle PainNCT05542888
Effects of Antenatal Exercises With Sacroiliac Joint Mobilization in Pregnancy Related Pelvic Girdle Pain
A study testing Sacroiliac joint mobilization and Standard therapy in people with Pregnancy Related Pelvic Girdle Pain, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Pelvic girdle pain is the frequently occuring pregnancy-related musculoskeletal condition.It is defined as the pain experienced between the posterior iliac crest and the gluteal region, particularly in the sacroiliac joint.This condition is associated with difficulties in activities of daily life such as standing… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related Pelvic Girdle Pain
- What is being tested?
- Sacroiliac joint mobilization and Standard therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to Feb 2023
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both primiparous and multiparous gestational women of age 18-40 years
- Gestational age: 13-24 weeks of 2nd trimester
Who cannot join
- -History of: Miscarriages Early Neonatal Deaths Intra-uterine growth retardation Premature rupture of membranes Arthritis Twins/triplets pregnancies
- Present complain of Pregnancy Induced Hypertension(HIP)
- Placenta previa
Trial locations and contacts
1 site in 1 country.
About this study
Pelvic girdle pain is the frequently occuring pregnancy-related musculoskeletal condition.It is defined as the pain experienced between the posterior iliac crest and the gluteal region, particularly in the sacroiliac joint.This condition is associated with difficulties in activities of daily life such as standing, walking, working and sleeping hence affecting the quality of life.Various management strategies including antenatal exercises, sacro iliac joint belt, kinesiotaping, sacro iliac joint mobilization etc are used for treating the pelvic girdle pain.Different studies have shown the positive results of antenatal exercises, sacro iliac joint belt and kinesiotaping on the pelvic girdle pain but there is lack of data available to establish the efficacy of sacro iliac joint mobilization on pregnancy-related pelvic girdle pain.So this study aims tofulfill this gap by comparing the effects of antenatal exercises with sacro iliac jpint mobilization on pelvic pain, function and disability in pregnancy-related pelvic girdle pain
Read the detailed description
Pelvic girdle pain is defined as the pain experienced between the posterior iliac crest and the gluteal region, particularly in the sacro iliac joint.It is characterized by pain, instability, limitations in mobility and functioning of the pelvic region.This condition is found to be associated with difficulties in activities of daily life such as standing, walking, working and sleeping hence, affecting the quality of life.Pelvic girdle pain is on of the major preganacy-related problems that affects about 50% of the pregnant females.Previous studies have shown that about 33-50% of the women repost pelvic girdle pain before 20 weeks of gestation and the the prevalavce may reach 60-70% in late pregnancy.Different management strategies including antenatal exercises, sacro iliac joint belt, kinesiotaping, sacro iliac joint mobilization etc are used to treat pelvic girdle pain.Different studies have shown the positive results of antenatal exercises, sacro iliac joint belt and kinesiotaping but there is dearth of evidence to establish the efficacy of sacro iliac joint mobilization on pregnancy-related pelvic girdle pain.This study aims to fulfill this gap by comparing the effects of antenatal exercises with sacro iliac joint mobilization on pelvic pain, function and disability.
This randomized control trial will be conducted in Obs\&Gynae Opd of Fauji Foundation Hospital using non-probability purposive sampling.Participants will be briefed regarding the study objectives, procedure, risks and benefits of treament, voluntary participation and right to withdraw.Written informed consent will be taken from all the participants before conducting the research.Details of exercise program will be explained to them.Screening will be done by using PAR Q.Dignostic tests will be applied to confirm the pelvic girdle pain.FABERs test and Posterior Pelvic Pain Provocation test will be used for this purpose.Then the selected participants will be randomized into 2 groups(experimental group and control group)via lottery method. Participants will complete Numeric Rating Pain Scale(NRPS) for pain, Pelvic Girdle Questionnaire for disability measurement and will perform Active Straight Leg raise test(ASLR) to measure pelvic function.All of these measurements will be taken at baseline, after 2 weeks and then after 4 weeks of intervention.
The treatment protocol of both groups is as follows:
Group 1(Control group):Postural education, hot pack, antenatal exercises(i.e deep breathing, stretching, kegel exercises, Mitchells physiologic relaxation technique and walk.
Group 2(Experimental group):Postural ecucation, hot pack, antenatal exercises(i.e deep breathing, stretching, kegel exercises, Mitchells physiologic relaxation technique and walk) and sacro iliac joint mobilization in side lying position(1 set of 30 oscillatios per session)
- Conditions
- Pregnancy Related Pelvic Girdle Pain
- Being tested
- Sacroiliac joint mobilization, Standard therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacroiliac joint mobilizationProcedure or surgery
Sacroiliac joint mobilization will be performed with the patient in side lying position in which grade I,II pain relief mobilization will be given in PA direction.It will be given as 1 set of 30 oscillations per session, 3 times per week for 4 weeks.
Standard therapyProcedure or surgery
Postural education, Hot pack, Antenatal exercises
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Postural education Hot pack(10 min) Antenatal exercises(i.e. deep breathing(5 min), stretching(5 min), kegel exercises(5 min), Mitchells physiologic relaxation technique(10 min) and walk(10 min) Sacro iliac joint mobilization(5 min) Total duration:50 min/session Receives: Procedure: Sacroiliac joint mobilization; Procedure: Standard therapy |
| Control group | Active comparator | Postural education Hot pack(10 min) Antenatal exercises(i.e.deep breathing(5 min), stretching(5 min), kegel exercises(5 min), Mitchells physiologic relaxation technique(10 min) and walk(10 min) Total duration:45 min/session Receives: Procedure: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be measured on numeric rating pain scale. It consists of 11 points( interval 0-10), where 0 corresponds to no pain and 10 corresponds to worst pain imaginable. A graphical representation of 11 spaces is used for patients own evaluation of his or her pain.
Measured: 4 weeks
Disability
The Pelvic Girdle Questionnaire(PGQ) is a condition-specific tool that assesses activity limitation and symptoms in patients with pelvic girdle pain .It consists of 20 activity items and 5 symptoms items scored on a 4-point response scale .Each question is scored from "Not at all" to "to a large extent". Items scores are summed and transformed to yield a score of 0 to 100, where 100 is the worst possible score
Measured: 4 weeks
Pelvic function
The Active Straight Leg Raise Test is a functional test used to assess pelvic girdle pain. It consists of a 6-point scale: not difficult at all=0, minimally difficult=1, somewhat difficult=2, fairly difficult=3, very difficult=4, unable to do=5. The scores of both sides are added so that the summed score can range from 0-10. Impairment is considered severe if the summed bilateral score is at least 4.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Mar 2022
- Primary completionJan 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy Related Pelvic Girdle PainStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Model description
- This study is a randomized controlled trial which will consist of two groups. Once will recieve conventional physcial therapy and the sencond will recieve conventional physcial therapy with sacroiliac joint mobilization.Both groups will be recruited concurrently.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542888
- Sponsor's protocol ID
- FUI/CTR/2022/16
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antenatal Exercises With Sacroiliac Joint Mobilization in Pregnancy Related Pelvic Girdle Pain
- ClinicalTrials.gov ID
- NCT05542888
- Acronym / sponsor ID
- FUI/CTR/2022/16
- Conditions
- Pregnancy Related Pelvic Girdle Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 16 Sep 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.
Pelvic girdle pain is the frequently occuring pregnancy-related musculoskeletal condition.It is defined as the pain experienced between the posterior iliac crest and the gluteal region, particularly in the sacroiliac joint.This condition is associated with difficulties in activities of daily life such as standing, walking, working and sleeping hence affecting the quality of life.Various management strategies including antenatal exercises, sacro iliac joint belt, kinesiotaping, sacro iliac joint mobilization etc are used for treating the pelvic girdle pain.Different studies have shown the positive results of antenatal exercises, sacro iliac joint belt and kinesiotaping on the pelvic girdle pain but there is lack of data available to establish the efficacy of sacro iliac joint mobilization on pregnancy-related pelvic girdle pain.So this study aims tofulfill this gap by comparing the effects of antenatal exercises with sacro iliac jpint mobilization on pelvic pain, function and disability in pregnancy-related pelvic girdle pain
Detailed description
Pelvic girdle pain is defined as the pain experienced between the posterior iliac crest and the gluteal region, particularly in the sacro iliac joint.It is characterized by pain, instability, limitations in mobility and functioning of the pelvic region.This condition is found to be associated with difficulties in activities of daily life such as standing, walking, working and sleeping hence, affecting the quality of life.Pelvic girdle pain is on of the major preganacy-related problems that affects about 50% of the pregnant females.Previous studies have shown that about 33-50% of the women repost pelvic girdle pain before 20 weeks of gestation and the the prevalavce may reach 60-70% in late pregnancy.Different management strategies including antenatal exercises, sacro iliac joint belt, kinesiotaping, sacro iliac joint mobilization etc are used to treat pelvic girdle pain.Different studies have shown the positive results of antenatal exercises, sacro iliac joint belt and kinesiotaping but there is dearth of evidence to establish the efficacy of sacro iliac joint mobilization on pregnancy-related pelvic girdle pain.This study aims to fulfill this gap by comparing the effects of antenatal exercises with sacro iliac joint mobilization on pelvic pain, function and disability.
This randomized control trial will be conducted in Obs\&Gynae Opd of Fauji Foundation Hospital using non-probability purposive sampling.Participants will be briefed regarding the study objectives, procedure, risks and benefits of treament, voluntary participation and right to withdraw.Written informed consent will be taken from all the participants before conducting the research.Details of exercise program will be explained to them.Screening will be done by using PAR Q.Dignostic tests will be applied to confirm the pelvic girdle pain.FABERs test and Posterior Pelvic Pain Provocation test will be used for this purpose.Then the selected participants will be randomized into 2 groups(experimental group and control group)via lottery method. Participants will complete Numeric Rating Pain Scale(NRPS) for pain, Pelvic Girdle Questionnaire for disability measurement and will perform Active Straight Leg raise test(ASLR) to measure pelvic function.All of these measurements will be taken at baseline, after 2 weeks and then after 4 weeks of intervention.
The treatment protocol of both groups is as follows:
Group 1(Control group):Postural education, hot pack, antenatal exercises(i.e deep breathing, stretching, kegel exercises, Mitchells physiologic relaxation technique and walk.
Group 2(Experimental group):Postural ecucation, hot pack, antenatal exercises(i.e deep breathing, stretching, kegel exercises, Mitchells physiologic relaxation technique and walk) and sacro iliac joint mobilization in side lying position(1 set of 30 oscillatios per session)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized controlled trial which will consist of two groups. Once will recieve conventional physcial therapy and the sencond will recieve conventional physcial therapy with sacroiliac joint mobilization.Both groups will be recruited concurrently.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Sacroiliac joint mobilization, Procedure: Standard therapyPostural education Hot pack(10 min) Antenatal exercises(i.e. deep breathing(5 min), stretching(5 min), kegel exercises(5 min), Mitchells physiologic relaxation technique(10 min) and walk(10 min) Sacro iliac joint mobilization(5 min) Total duration:50 min/session |
| Control group | Active comparator | Procedure: Standard therapyPostural education Hot pack(10 min) Antenatal exercises(i.e.deep breathing(5 min), stretching(5 min), kegel exercises(5 min), Mitchells physiologic relaxation technique(10 min) and walk(10 min) Total duration:45 min/session |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Both primiparous and multiparous gestational women of age 18-40 years
- Gestational age: 13-24 weeks of 2nd trimester
Key exclusion criteria (3 listed)
- -History of: Miscarriages Early Neonatal Deaths Intra-uterine growth retardation Premature rupture of membranes Arthritis Twins/triplets pregnancies
- Present complain of Pregnancy Induced Hypertension(HIP)
- Placenta previa
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 |
|---|---|---|
| Sacroiliac joint mobilizationSacroiliac joint mobilization will be performed with the patient in side lying position in which grade I,II pain relief mobilization will be given in PA direction.It will be given as 1 set of 30 oscillations per session, 3 times per week for 4 weeks. | Procedure or surgery | Experimental group |
| Standard therapyPostural education, Hot pack, Antenatal exercises | Procedure or surgery | Control group, Experimental group |
Primary outcome
Pain intensity
Time frame: 4 weeks
Pain intensity will be measured on numeric rating pain scale. It consists of 11 points( interval 0-10), where 0 corresponds to no pain and 10 corresponds to worst pain imaginable. A graphical representation of 11 spaces is used for patients own evaluation of his or her pain.
Disability
Time frame: 4 weeks
The Pelvic Girdle Questionnaire(PGQ) is a condition-specific tool that assesses activity limitation and symptoms in patients with pelvic girdle pain .It consists of 20 activity items and 5 symptoms items scored on a 4-point response scale .Each question is scored from "Not at all" to "to a large extent". Items scores are summed and transformed to yield a score of 0 to 100, where 100 is the worst possible score
Pelvic function
Time frame: 4 weeks
The Active Straight Leg Raise Test is a functional test used to assess pelvic girdle pain. It consists of a 6-point scale: not difficult at all=0, minimally difficult=1, somewhat difficult=2, fairly difficult=3, very difficult=4, unable to do=5. The scores of both sides are added so that the summed score can range from 0-10. Impairment is considered severe if the summed bilateral score is at least 4.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacroiliac joint mobilization and Standard therapy in people with Pregnancy Related Pelvic Girdle Pain, run by Foundation University Islamabad 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 2 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: status not confirmed, as of the sponsor's last update on 16 Sep 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?
Results are not available in the source record.
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?
Pain intensity (time frame: 4 weeks). The study lists 3 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 16 Sep 2022.