Low Back PainNCT07094633
Comparative Effects of Kegel Versus Clamshell Exercises on Low Back Pain in Women With Uterine Fibroids: A Randomized Clinical Trial
A study testing Kegel Exercise Group and Clamshell Exercise Group in people with Low Back Pain and Uterine Fibroids (UF), run by University of Faisalabad at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Low Back Pain, Uterine Fibroids (UF)
- What is being tested?
- Kegel Exercise Group and Clamshell Exercise Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Feb 2025to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Low Back Pain, Uterine Fibroids (UF)
- Being tested
- Kegel Exercise Group, Clamshell Exercise Group
- Medical subject headings
- Low Back Pain, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kegel Exercise GroupProcedure or surgery
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 GroupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Kegel Exercise Group | Experimental | Not described Receives: Procedure: Kegel Exercise Group |
| Clamshell Exercise Group | Active comparator | Not described Receives: Procedure: Clamshell Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
Functional Disability
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start14 Feb 2025
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Izza Ayub; PT, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094633
- Sponsor's protocol ID
- TUF/PB/34/1027/34
- Status last verified
- Feb 2025
- First submitted
- 23 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Kegel Versus Clamshell Exercises on Low Back Pain in Women With Uterine Fibroids: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07094633
- Acronym / sponsor ID
- TUF/PB/34/1027/34
- Conditions
- Low Back Pain, Uterine Fibroids (UF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kegel Exercise Group | Experimental | Procedure: Kegel Exercise Group |
| Clamshell Exercise Group | Active comparator | Procedure: Clamshell Exercise Group |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kegel Exercise GroupThe 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. | Procedure or surgery | Kegel Exercise Group |
| Clamshell Exercise GroupThe 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. | Procedure or surgery | Clamshell Exercise Group |
Primary outcome
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.
1 secondary outcome
Functional Disability
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kegel Exercise Group and Clamshell Exercise Group in people with Low Back Pain and Uterine Fibroids (UF), run by University of Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back Pain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.