Pregnancy RelatedNCT06120959
Effect of Adding Pelvic Floor Exercises to the Stabilization Exercises in Treating Low Back Pain During Pregnancy
A study testing Stabilization exercise and Pelvic floor exercise in people with Pregnancy Related, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to know the effect of adding pelvic floor exercises to the stabilization exercises in treating low back pain during pregnancy. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Stabilization exercise and Pelvic floor exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 30 Jun 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Their ages will range from 25-35 year.
- They will be at least in the 2nd trimester.
- Doesn't receive any treatment for her pregnancy-related low back pain.
- Low back pain with or without radiculopathy.
- Being in prenatal clinic follow up.
Who cannot join
- Previous pelvic floor muscle training.
- Previous pelvic / spine surgery.
- Structural anomaly.
- Urinary tract infection.
- Severe cardiovascular or metabolic disease.
- Twins or more.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adding Pelvic Floor Exercises to the Stabilization Exercises in Treating Low Back Pain During Pregnancy: A Randomized Controlled Trial
The purpose of the study is to know the effect of adding pelvic floor exercises to the stabilization exercises in treating low back pain during pregnancy.
Read the detailed description
Low back pain (LBP) is a frequent condition in pregnancy, which may begin early, but the maximum pain out-put is typically found during the third trimester. (Adriana et al., 2020). LBP is pain or discomfort located between the 12th rib and the gluteal fold and PGP has been defined as 'pain experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints' (Margie et al., 2018). LBP is a common health concern among women during pregnancy worldwide. The prevalence of LBP during pregnancy varies from and within sub regions. Moderate to severe disability associated with LBP is often a burden in pregnancy. The negative impact of LBP during pregnancy has implications on maternal quality of life and satisfaction with pregnancy. The duration of LBP in pregnancy correlates directly with the duration of absenteeism, physical dysfunction and poor work performance (Njoku et al., 2021).
The pelvic floor muscles (PFMs) are another component of the local stabilizing system, which in associated with deep abdominal and multifidus muscles play a critical role in lumbo-pelvic stability. Insufficiency can occur as a result of trauma, surgery, poor movement patterns, and childbirth. Previous studies reported that compared with healthy subjects, PFMs endurance time decreases in patients with pregnancy-related LBP (PRLBP). In addition, motor control of these muscles is altered in presence of sacroiliac join pain. Pregnancy can affect PFMs in several ways. The enhancement of hormonal level leads to muscle inhibition. Simultaneously, the growing of the uterus pushes pelvic organs downward and exert continuous strain on PFMs. Delivery itself changes the pelvic supportive system. These changes can impair PFMs function and load transferring in lumbo-pelvic area and lead to development of LBP. It was found that there is a synergistic relationship between local stabilizing muscles. Therefore, it could be supposed that a treatment program, which addresses local stabilizing muscles, can improve PFM function and decrease clinical symptoms in PRLBP (Zahra et al., 2018).
They were divided randomly into two equal groups using coin toss method;Group A (Control Group): consisted of 24 pregnant women with LBP and treated by routine treatment (Stabilization exercise) only 3 times per week for 6 successive weeks. Group B (Study Group): consisted of 24 pregnant women with LBP and treated by same program for group A and pelvic floor exercise only 3 times per week for 6 successive weeks.
- Conditions
- Pregnancy Related
- Being tested
- Stabilization exercise, Pelvic floor exercise
- Keywords
- PELVIC FLOOR EXERCISES, STABILIZATION EXERCISES, LOW BACK PAIN, PREGNANCY
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilization exerciseOther
The exercise program included Bridging, Seated Marching Twist, Quadruped pelvic tilts, Modified Side Plank, and Bird dog for 6 successive weeks. .
Pelvic floor exerciseOther
The pelvic floor exercise protocol involved several steps. Prior to commencing the exercise, women were instructed to empty their bladders. The initial position for the woman was lying in a crook lying position. They were then guided to contract and hold their pelvic muscles for a duration of 5 to 6 seconds, followed by a relaxation period of 5 to 6 seconds. As the sessions progressed, patients were encouraged to perform the exercises in different positions: from a quadriped position, then sitting, followed by standing, and eventually while walking. Each session had a duration of 20 minutes, and the recommended frequency was three times a week for a span of 6 weeks. The repetitions were set at 10 to 15 per set, with two sets in total.
| Study group | Role | What they receive |
|---|---|---|
| Control group A | Active comparator | They received exercise program in the form of Bridging, Seated Marching Twist, Quadruped pelvic tilts, Modified Side Plank, and Bird dog for 6 successive weeks. Receives: Other: Stabilization exercise |
| Study group B | Experimental | They received the same stabilization exercise program plus Pelvic floor exercise for 6 successive weeks. Receives: Other: Stabilization exercise; Other: Pelvic floor exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The visual analogue scale (VAS)
The VAS is a quick and quite easy-to-use user-friendly instrument for rating pain. The VAS is a 10 cm line with descriptors at each end (from none to severe), along which respondents place a mark indicating their subjective pain. The score is measured as the distance of the mark from zero end of the line (Seyedehet.al.,2018). It was used to assess low back pain intensity for each woman in both groups before and after treatment.
Measured: 6 weeks
Oswetry disability index (ODI)
The ODI is a reliable scale to detect improvement or worsening in most subjects with LBP. The questionnaire consists of 10 items of pain, lifting, self-care ability, the ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each item is scored from 0-5, with higher values representing greater disability. The total score would be multiplied by 2 and expressed as a percentage. Zero means no physical disability and 100 mean the maximum disability (Seyedeh et al., 2018). It was used to assess functional disability for each woman in both groups before and after treatment.
Measured: 6 weeks
Modified Schober Method
The Modified Schober Method was employed to assess lumbar flexion range of motion. The patient stood with specific spinal positions while the therapist marked anatomical points. A tape measure was used to quantify the flexion range of motion during forward bending
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Hany Ibrahiem, Cairo University
- Investigators
- Dalia M. Kamel, Professor, Study chair, Professor of physical therapy for women's health, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120959
- Sponsor's protocol ID
- P.T.REC/012/004252
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2023
- Last updated
- 7 Nov 2023
- 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Pelvic Floor Exercises to the Stabilization Exercises in Treating Low Back Pain During Pregnancy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06120959
- Acronym / sponsor ID
- P.T.REC/012/004252
- Conditions
- Pregnancy Related
- Keywords
- PELVIC FLOOR EXERCISES, STABILIZATION EXERCISES, LOW BACK PAIN, PREGNANCY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 7 Nov 2023 (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.
The purpose of the study is to know the effect of adding pelvic floor exercises to the stabilization exercises in treating low back pain during pregnancy.
Detailed description
Low back pain (LBP) is a frequent condition in pregnancy, which may begin early, but the maximum pain out-put is typically found during the third trimester. (Adriana et al., 2020). LBP is pain or discomfort located between the 12th rib and the gluteal fold and PGP has been defined as 'pain experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints' (Margie et al., 2018). LBP is a common health concern among women during pregnancy worldwide. The prevalence of LBP during pregnancy varies from and within sub regions. Moderate to severe disability associated with LBP is often a burden in pregnancy. The negative impact of LBP during pregnancy has implications on maternal quality of life and satisfaction with pregnancy. The duration of LBP in pregnancy correlates directly with the duration of absenteeism, physical dysfunction and poor work performance (Njoku et al., 2021).
The pelvic floor muscles (PFMs) are another component of the local stabilizing system, which in associated with deep abdominal and multifidus muscles play a critical role in lumbo-pelvic stability. Insufficiency can occur as a result of trauma, surgery, poor movement patterns, and childbirth. Previous studies reported that compared with healthy subjects, PFMs endurance time decreases in patients with pregnancy-related LBP (PRLBP). In addition, motor control of these muscles is altered in presence of sacroiliac join pain. Pregnancy can affect PFMs in several ways. The enhancement of hormonal level leads to muscle inhibition. Simultaneously, the growing of the uterus pushes pelvic organs downward and exert continuous strain on PFMs. Delivery itself changes the pelvic supportive system. These changes can impair PFMs function and load transferring in lumbo-pelvic area and lead to development of LBP. It was found that there is a synergistic relationship between local stabilizing muscles. Therefore, it could be supposed that a treatment program, which addresses local stabilizing muscles, can improve PFM function and decrease clinical symptoms in PRLBP (Zahra et al., 2018).
They were divided randomly into two equal groups using coin toss method;Group A (Control Group): consisted of 24 pregnant women with LBP and treated by routine treatment (Stabilization exercise) only 3 times per week for 6 successive weeks. Group B (Study Group): consisted of 24 pregnant women with LBP and treated by same program for group A and pelvic floor exercise only 3 times per week for 6 successive weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group A | Active comparator | Other: Stabilization exerciseThey received exercise program in the form of Bridging, Seated Marching Twist, Quadruped pelvic tilts, Modified Side Plank, and Bird dog for 6 successive weeks. |
| Study group B | Experimental | Other: Stabilization exercise, Other: Pelvic floor exerciseThey received the same stabilization exercise program plus Pelvic floor exercise for 6 successive weeks. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Their ages will range from 25-35 year.
- They will be at least in the 2nd trimester.
- Doesn't receive any treatment for her pregnancy-related low back pain.
- Low back pain with or without radiculopathy.
- Being in prenatal clinic follow up.
Key exclusion criteria (6 listed)
- Previous pelvic floor muscle training.
- Previous pelvic / spine surgery.
- Structural anomaly.
- Urinary tract infection.
- Severe cardiovascular or metabolic disease.
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 |
|---|---|---|
| Stabilization exerciseThe exercise program included Bridging, Seated Marching Twist, Quadruped pelvic tilts, Modified Side Plank, and Bird dog for 6 successive weeks. . | Other | Control group A, Study group B |
| Pelvic floor exerciseThe pelvic floor exercise protocol involved several steps. Prior to commencing the exercise, women were instructed to empty their bladders. The initial position for the woman was lying in a crook lying position. They were then guided to contract and hold their pelvic muscles for a duration of 5 to 6 seconds, followed by a relaxation period of 5 to 6 seconds. As the sessions progressed, patients were encouraged to perform the exercises in different positions: from a quadriped position, then sitting, followed by standing, and eventually while walking. Each session had a duration of 20 minutes, and the recommended frequency was three times a week for a span of 6 weeks. The repetitions were set at 10 to 15 per set, with two sets in total. | Other | Study group B |
Primary outcome
The visual analogue scale (VAS)
Time frame: 6 weeks
The VAS is a quick and quite easy-to-use user-friendly instrument for rating pain. The VAS is a 10 cm line with descriptors at each end (from none to severe), along which respondents place a mark indicating their subjective pain. The score is measured as the distance of the mark from zero end of the line (Seyedehet.al.,2018). It was used to assess low back pain intensity for each woman in both groups before and after treatment.
Oswetry disability index (ODI)
Time frame: 6 weeks
The ODI is a reliable scale to detect improvement or worsening in most subjects with LBP. The questionnaire consists of 10 items of pain, lifting, self-care ability, the ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each item is scored from 0-5, with higher values representing greater disability. The total score would be multiplied by 2 and expressed as a percentage. Zero means no physical disability and 100 mean the maximum disability (Seyedeh et al., 2018). It was used to assess functional disability for each woman in both groups before and after treatment.
Modified Schober Method
Time frame: 6 weeks
The Modified Schober Method was employed to assess lumbar flexion range of motion. The patient stood with specific spinal positions while the therapist marked anatomical points. A tape measure was used to quantify the flexion range of motion during forward bending
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 7 Nov 2023.
Related trials for Pregnancy Related
Not yet recruitingPhase 3
Sequential Chemotherapy Followed by Ultrahypofractionated Radiotherapy for Muscle-Invasive Bladder Cancer
Bladder Cancer, TURBT
Active, not recruitingObservational study
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Autosomal Dominant Polycystic Kidney Disease
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
Not yet recruiting
Justice Core Trial
Pregnancy, Substance Use Disorder (SUD)
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
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.
Dalia M. Kamel, Professor study chair
Professor of physical therapy for women's health, Cairo 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 Stabilization exercise and Pelvic floor exercise in people with Pregnancy Related, run by Cairo University at 1 site in Egypt.
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 6 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 7 Nov 2023. 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 Egypt. 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?
The visual analogue scale (VAS) (time frame: 6 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 7 Nov 2023.