- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07667634
Effect of Pelvic Floor Muscles Down Training on Postpartum Coccydynia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alyaa R. Abdelmoity, Bachelor
- Phone Number: +01017357127
- Email: alyaaragab83@gmail.com
Study Contact Backup
- Name: Elham Shahat, PHD
- Phone Number: 01206146539
- Email: elhamramadan70@cu.edu.eg
Study Locations
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Cairo, Egypt
- Alyaa Ragab Abdelmoity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Neurological disorders.
- Musculoskeletal disorders as Abnormal coccygeal morphology or abnormal scoliotic deformity
- Infection or malignancy.
- Fibromyalgia or myopathy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pelvic floor muscle down training and stretching exercise group
The participants will receive pelvic floor down training and stretching exercises, 3 sessions per week for 4 weeks.
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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 exercises for piriform and iliopsoas muscles with 5 second stretch hold, 5 repetitions/session for 5 sessions/week for four weeks.
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Active Comparator: Stretching exercise group
The participants will receive stretching exercises, 3 sessions per week for 4 weeks.
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stretching exercises for piriform and iliopsoas muscles with 5 second stretch hold, 5 repetitions/session for 5 sessions/week for four weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 4 weeks
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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
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Function disability
Time Frame: 4 weeks
|
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.
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4 weeks
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Pelvic floor muscle tone
Time Frame: 4 weeks
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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:
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hossam Kamel, Professor, Al-Azhar University
- Study Chair: Afaf Botla, Professor, Cairo University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 012/005734
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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