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

Not Applicable

Completed

• Conditions: Pregnancy Related
• Interventions: Other: Stabilization exercise; Other: Pelvic floor exercise

• Registration Number: NCT06120959
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-11
• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-02
• Last Update Submitted: 2023-11-02
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group B	Pelvic floor exercise	They received the same stabilization exercise program plus Pelvic floor exercise for 6 successive weeks.
Control group A	Stabilization exercise	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.
Study group B	Stabilization exercise	They received the same stabilization exercise program plus Pelvic floor exercise for 6 successive weeks.

Primary Outcome Measures

Name	Time	Method
Oswetry disability index (ODI)	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	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
The visual analogue scale (VAS)	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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, Egypt