Tailbone DisordersNCT07667634
Effect of Pelvic Floor Muscles Down Training on Postpartum Coccydynia
A study testing Pelvic floor down training exercise and Stretching exercises in people with Tailbone Disorders, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the effect of pelvic floor muscle down training on postpartum coccydynia. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Tailbone Disorders
- What is being tested?
- Pelvic floor down training exercise and Stretching exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Their ages will range from 18 to 30 years.
- Suffering from moderate coccyx pain which assessed by VAS.
- Their body mass index will be equal or less than 30 kg/m².
- Primipara and multipara -2:3 times‖ women.
- Six months to one year after childbirth.
Who cannot join
- Neurological disorders.
- Musculoskeletal disorders as Abnormal coccygeal morphology or abnormal scoliotic deformity
- Infection or malignancy.
- Fibromyalgia or myopathy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study will be conducted to investigate the effect of pelvic floor muscle down training on postpartum coccydynia.
Read the detailed description
One complication of coccydynia is that it may become a chronic pain syndrome. Early and thorough medical attention may help patients avoid delays in diagnosis and treatment. The hope is that this will help decrease the chances of the pain becoming persistent and disabling. Many patients with coccydynia experience relief of symptoms within weeks or months of onset, whether or not they receive medical treatment. The success of conservative treatment has been reported to be 90% .
The significance of musculoskeletal and myofascial pain in chronic pelvic pain is becoming increasingly established. the findings suggest a direct link between impairments in coccyx mobility, pain, and muscle spasm and dysfunction of the pelvic floor muscles. Therefore, pelvic floor muscle impairments related to the coccyx may need to be addressed in treatment considerations .
There is a risk of pelvic floor dysfunction (PFD) from baby delivery. Many clinical guidelines recommend pelvic floor muscle training (PFMT) as the conservative treatment for PFD because pelvic floor muscles (PFMs) play a crucial role in development of PFD. PFM training is the most popular conservative intervention for PFD. Its role in PFM improvement is becoming more and more important along with the rapid development of rehabilitation medicine and it is more and more acceptable by women as their requirements for improvement of quality of life are getting stronger.
PFM function requires activation and relaxation at appropriate times and amounts to maintain pelvic organ support and closure, and enable passage. PFM tone that is greater than that required for a specific context (referred to as "increased" tone by the International Continence Society) could affect function and explain some features of pelvic health conditions, such as compromised relaxation or lengthening of PFM (eg, functional obstruction or interference with intercourse) and muscle ischemia (as implicated in some pain conditions). PFM tone could be increased by many factors, including stress, fear, anxiety, psychological trauma, injury, surgery or radiation, and hormonal, lifestyle, and occupational factors. Although plausible, evidence for increased PFM tone remains unclear
- Conditions
- Tailbone Disorders
- Being tested
- Pelvic floor down training exercise, Stretching exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor down training exerciseOther
Patient will be asked to breathe deeply and bring her awareness to her pelvic floor. Feel her muscles relax as she inhales and maintain position for 5 seconds and then release for the same amount of time. Do two to three sets of 10 throughout the day. Once she masters this, she can try holding and releasing for longer periods of time.
Make sure she is breathing while doing these exercises. It 's important to breathe all the way into her stomach (instead of only breathing into her chest). Keeping her belly relaxed. This is known as diaphragmatic breathing.
Stretching exercisesOther
stretching exercises for piriform and iliopsoas muscles with 5 second stretch hold, 5 repetitions/session for 5 sessions/week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor muscle down training and stretching exercise group | Experimental | The participants will receive pelvic floor down training and stretching exercises, 3 sessions per week for 4 weeks. Receives: Other: Pelvic floor down training exercise; Other: Stretching exercises |
| Stretching exercise group | Active comparator | The participants will receive stretching exercises, 3 sessions per week for 4 weeks. Receives: Other: Stretching exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Visual analogue scale will be used to measure the pain intensity before and after the treatment program. The VAS is a 10-point scale comprising a number from 0 through 10; 0 indicates "no pain", and 10 indicates the "worst imaginable pain". VAS is a valid \& reliable pain rating scale
Measured: 4 weeks
Secondary outcomes (2)
Function disability
Oswestry Disability Index will be used to assess the function disability for all patients before and after the treatment program. It measures functional recovery and severity of pain, self-care, lifting, walking, sitting, standing, social life, sleep, travel, and pain level across 10 items. As the total score increases, so does the level of disability. The maximum score is 50 points, with 31-50 classified as severe, 11-30 as moderate, and 1-10 as mild disability. The total score obtained from the patient is converted into percentage values to evaluate the disability percentage.
Measured: 4 weeks
Pelvic floor muscle tone
Perineometer will be performed with the patient in the right lateral position. The perianal area will be cleaned with alcohol. Pressure- probe should be different for each individual. Probe sensor should be placed 3.5 cm inside the rectum where it coincides with PFM bulk. Patients will be asked to:
- Breathe deeply and bring her awareness to her pelvic floor. Feel her muscles relax and drop down as she inhales.
- Hold the position for 5 seconds and then release for the same amount of time. Do two to three sets of 10 throughout the day. Once she masters this, she can try holding and releasing for longer periods of time.
- Make sure she is breathing while doing these exercises. It's important to breathe all the way into her stomach as she inhales (instead of only breathing into her chest). Keeping her belly relaxed helps. This is known as diaphragmatic breathing
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 posted25 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tailbone DisordersStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alyaa Ragab, Cairo University
- Investigators
- Hossam Kamel, Professor, Study director, Al-Azhar UniversityAfaf Botla, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667634
- Sponsor's protocol ID
- 012/005734
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pelvic Floor Muscles Down Training on Postpartum Coccydynia
- ClinicalTrials.gov ID
- NCT07667634
- Acronym / sponsor ID
- 012/005734
- Conditions
- Tailbone Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 25 Jun 2026 (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.
This study will be conducted to investigate the effect of pelvic floor muscle down training on postpartum coccydynia.
Detailed description
One complication of coccydynia is that it may become a chronic pain syndrome. Early and thorough medical attention may help patients avoid delays in diagnosis and treatment. The hope is that this will help decrease the chances of the pain becoming persistent and disabling. Many patients with coccydynia experience relief of symptoms within weeks or months of onset, whether or not they receive medical treatment. The success of conservative treatment has been reported to be 90% .
The significance of musculoskeletal and myofascial pain in chronic pelvic pain is becoming increasingly established. the findings suggest a direct link between impairments in coccyx mobility, pain, and muscle spasm and dysfunction of the pelvic floor muscles. Therefore, pelvic floor muscle impairments related to the coccyx may need to be addressed in treatment considerations .
There is a risk of pelvic floor dysfunction (PFD) from baby delivery. Many clinical guidelines recommend pelvic floor muscle training (PFMT) as the conservative treatment for PFD because pelvic floor muscles (PFMs) play a crucial role in development of PFD. PFM training is the most popular conservative intervention for PFD. Its role in PFM improvement is becoming more and more important along with the rapid development of rehabilitation medicine and it is more and more acceptable by women as their requirements for improvement of quality of life are getting stronger.
PFM function requires activation and relaxation at appropriate times and amounts to maintain pelvic organ support and closure, and enable passage. PFM tone that is greater than that required for a specific context (referred to as "increased" tone by the International Continence Society) could affect function and explain some features of pelvic health conditions, such as compromised relaxation or lengthening of PFM (eg, functional obstruction or interference with intercourse) and muscle ischemia (as implicated in some pain conditions). PFM tone could be increased by many factors, including stress, fear, anxiety, psychological trauma, injury, surgery or radiation, and hormonal, lifestyle, and occupational factors. Although plausible, evidence for increased PFM tone remains unclear
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle down training and stretching exercise group | Experimental | Other: Pelvic floor down training exercise, Other: Stretching exercisesThe participants will receive pelvic floor down training and stretching exercises, 3 sessions per week for 4 weeks. |
| Stretching exercise group | Active comparator | Other: Stretching exercisesThe participants will receive stretching exercises, 3 sessions per week for 4 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Their ages will range from 18 to 30 years.
- Suffering from moderate coccyx pain which assessed by VAS.
- Their body mass index will be equal or less than 30 kg/m².
- Primipara and multipara -2:3 times‖ women.
- Six months to one year after childbirth.
Key exclusion criteria (4 listed)
- Neurological disorders.
- Musculoskeletal disorders as Abnormal coccygeal morphology or abnormal scoliotic deformity
- Infection or malignancy.
- Fibromyalgia or myopathy.
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 |
|---|---|---|
| Pelvic floor down training exercisePatient will be asked to breathe deeply and bring her awareness to her pelvic floor. Feel her muscles relax as she inhales and maintain position for 5 seconds and then release for the same amount of time. Do two to three sets of 10 throughout the day. Once she masters this, she can try holding and releasing for longer periods of time. Make sure she is breathing while doing these exercises. It 's important to breathe all the way into her stomach (instead of only breathing into her chest). Keeping her belly relaxed. This is known as diaphragmatic breathing. | Other | Pelvic floor muscle down training and stretching exercise group |
| Stretching exercisesstretching exercises for piriform and iliopsoas muscles with 5 second stretch hold, 5 repetitions/session for 5 sessions/week for four weeks. | Other | Pelvic floor muscle down training and stretching exercise group, Stretching exercise group |
Primary outcome
Pain intensity
Time frame: 4 weeks
Visual analogue scale will be used to measure the pain intensity before and after the treatment program. The VAS is a 10-point scale comprising a number from 0 through 10; 0 indicates "no pain", and 10 indicates the "worst imaginable pain". VAS is a valid \& reliable pain rating scale
2 secondary outcomes
Function disability
Time frame: 4 weeks
Pelvic floor muscle tone
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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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.
Hossam Kamel, Professor study director
Al-Azhar University
Afaf Botla, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor down training exercise and Stretching exercises in people with Tailbone Disorders, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 Jun 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alyaa R. Abdelmoity, Bachelor (+01017357127, alyaaragab83@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (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 25 Jun 2026.