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Completed

NCT Number: NCT07094633

Comparative Effects of Kegel Versus Clamshell Exercises on Low Back Pain in Women With Uterine Fibroids: A Randomized Clinical Trial

Uterine fibroids represent a significant health concern for many women of reproductive age. Common symptoms include a tilted pelvis, heavy menstrual bleeding, and lower back pain (LBP). Nonspecific LBP is particularly prevalent among individuals aged 30 to 50 years, and it is one of the major symptoms experienced by women with uterine fibroids. Exercise therapy has been shown to be an effective approach for managing this condition. In particular, Kegel exercises and Clamshell exercises have emerged as promising options. Kegel exercises primarily focus on strengthening the pelvic floor muscles, while Clamshell exercises target the pelvic region and play a vital role in alleviating LBP. Therefore, the aim of this study was to compare the effects of Kegel exercises and Clamshell exercises in reducing lower back pain in women with uterine fibroids.

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Key information

Conditions

Low Back Pain Back Pain Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Uterine Fibroids (UF)

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Faisalabad

Faisalābad, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 30-50 years
  • Chronic low back pain for the last 6 months
  • History of dysmenorrhea
  • Able to perform exercise independently
  • Not undergoing other treatments for treating LBP
  • Informed consent

Exclusion criteria

  • History of any surgery or trauma in last 3 months
  • Polycystic ovary syndrome (PCOS)
  • Any neurological issue
  • History of any form of cancer
  • History of recent abortion in the previous 3 months
  • Cardiac or renal diseases that affect the exercise participation of the patient

Treatment and study plan

Kegel Exercise Group

Procedure

The patient was positioned in a supine lying position, with the therapist standing beside them for guidance. They were instructed to engage and contract their pelvic floor muscles for 3 to 5 seconds, followed by a relaxation phase of 3 to 5 seconds.

Clamshell Exercise Group

Procedure

The patient was positioned in a side-lying posture with both knees flexed at 90 degrees. One hand was placed on the hip for stability, while the other supported the head. The therapist, standing nearby, instructed the patient to lift the top knee as high as comfortably possible while keeping the feet together. The position was held for 3 to 5 seconds, after which the knee was slowly lowered back to the starting position.

Primary outcomes

  1. Back Pain

    Time frame: 4 weeks

    Numeric pain rating scale (NPRS) is a tool used for measuring pain intensity in which individuals rate their pain from 0 to 10. 0 represents no pain while 10 represents the worst pain. It can be used in verbal, visual or written forms.

Secondary outcomes

  1. Functional Disability

    Time frame: 4 weeks

    Oswestry disability index (ODI) is a questionnaire designed to assess disability level in patients with LBP. It consists of 10 sections with 6 questions, each section is scored from 0-5, higher the score greater the disability.

Sponsors and collaborators

Lead sponsor

University of Faisalabad

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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