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

NCT06120959 | Completed

• 1 other identifier: P.T.REC/012/004252
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

PELVIC FLOOR EXERCISES; STABILIZATION EXERCISES; LOW BACK PAIN; PREGNANCY

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  6 weeks

Study Arms (2)

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.

Other: Stabilization exercise

Study group B

EXPERIMENTAL

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

Other: Stabilization exercise; Other: Pelvic floor exercise

Interventions

Stabilization exercise OTHER

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

Control group A; Study group B

Pelvic floor exercise 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.

Study group B

Eligibility Criteria

• Age: 25 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dalia M. Kamel, Professor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student at Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

EG (1)