NCT07094633

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
Last Updated

July 30, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

July 23, 2025

Last Update Submit

July 23, 2025

Conditions

Low Back PainUterine Fibroids (UF)

Outcome Measures

Primary Outcomes (1)

  • Back Pain

    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.

    4 weeks

Secondary Outcomes (1)

  • Functional Disability

    4 weeks

Study Arms (2)

Kegel Exercise Group

EXPERIMENTAL
Procedure: Kegel Exercise Group

Clamshell Exercise Group

ACTIVE COMPARATOR
Procedure: Clamshell Exercise Group

Interventions

Kegel Exercise GroupPROCEDURE

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.

Kegel Exercise Group
Clamshell Exercise GroupPROCEDURE

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.

Clamshell Exercise Group

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Faisalabad

Faisalābad, Pakistan

Location

MeSH Terms

Conditions

Low Back PainLeiomyoma

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Izza Ayub; PT

Study Record Dates

First Submitted

July 23, 2025

First Posted

July 30, 2025

Study Start

February 14, 2025

Primary Completion

May 30, 2025

Study Completion

May 30, 2025

Last Updated

July 30, 2025

Record last verified: 2025-02

Locations

PA(1)