Effect of Adding Pelvic Floor Exercises to the Stabilization Exercises in Treating Low Back Pain During Pregnancy

NCT ID: NCT06120959

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-06-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group A

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.

Group Type: ACTIVE_COMPARATOR

Stabilization exercise

Intervention Type: OTHER

The exercise program included Bridging, Seated Marching Twist, Quadruped pelvic tilts, Modified Side Plank, and Bird dog for 6 successive weeks. .

Study group B

They received the same stabilization exercise program plus Pelvic floor exercise for 6 successive weeks.

Group Type: EXPERIMENTAL

Stabilization exercise

Intervention Type: OTHER

The exercise program included Bridging, Seated Marching Twist, Quadruped pelvic tilts, Modified Side Plank, and Bird dog for 6 successive weeks. .

Pelvic floor exercise

Intervention Type: OTHER

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.

Interventions

Stabilization exercise

The exercise program included Bridging, Seated Marching Twist, Quadruped pelvic tilts, Modified Side Plank, and Bird dog for 6 successive weeks. .

Intervention Type: OTHER

Pelvic floor exercise

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Previous pelvic floor muscle training.
• Previous pelvic / spine surgery.
• Structural anomaly.
• Urinary tract infection.
• Severe cardiovascular or metabolic disease.
• Twins or more.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sara Hany Ibrahiem

Master student at Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dalia M. Kamel, Professor

Role: STUDY_CHAIR

Professor of physical therapy for women's health, Cairo University

Locations

Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004252

Identifier Type: -

Identifier Source: org_study_id