- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05788653
Comparison of Different Massages Tecniques on Chronic Pelvic Pain
April 4, 2023 updated by: Sena Öndeş, Atlas University
Comparison of the Effectiveness of Transverse Friction Massage and Thiele Massage in Female Patients With Chronic Pelvic Pain
The aim of this study is to investigate and compare the effectiveness of transverse friction and Thiele massage on pain, quality of life and sexual functions in female patients with chronic pelvic pain.
The study will be performed on 20 female patients with pelvic floor muscle tenderness, who applied to the Urology Clinic in Istanbul and were diagnosed with chronic pelvic pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sena Öndeş, MSc
- Phone Number: (+90)5387094535
- Email: senaaondes@gmail.com
Study Locations
-
-
Bağcılar
-
Istanbul, Bağcılar, Turkey, 34203
- Medicine Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Clinical Diagnosis of Pelvic floor muscle tenderness, Clinical Diagnosis of Chronic Pelvic Pain Syndrome
Exclusion Criteria:
Neurological pathologies ( such as hemiplegia, epilepsy, multiple sclerosis and parkinson's disease) Urogynecological surgery in the last 6 months, Severe pelvic prolapse, Pelvic malignancy and pelvic radiotherapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Thiele Group
The group will be given Thiele Massage twice a week for 4 weeks.
Thiele massage will be done with a stripping motion in the direction of the pelvic floor muscle fibers.
Approximately 15-20 repetitions will be applied to each of the pelvic floor muscle groups for 30 minutes.
|
Transvaginal Massage
|
Active Comparator: Transverse Friction Group
The group will be given Transverse Friction Massage twice a week for 4 weeks.
Transverse friction massage will be applied to each tense muscle group and trigger points for 3-5 minutes, crossing the direction of the pelvic floor muscle fibers.
Massage duration is approximately 30 minutes for each session.
|
Transvaginal Massage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: 4 weeks
|
The Visual Analog Scale is used to determine the severity of pain.
At the beginning of a 10 cm long line, there is the phrase "no pain" and "unbearable pain" at the end.
The person to be evaluated is asked to put a mark on the scale according to the severity of the pain.
Pain intensity is determined by measuring the distance from the expression "No pain" to the area where the person puts a sign.
Researchers will take two measurements, at the beginning and at the end of the intervention, to determine the change in pain parameters.
|
4 weeks
|
McGill Melzack Pain Questionnaire (MMPQ)
Time Frame: 4 weeks
|
The scale consists of four parts.
In the first part, the painful place is marked on the human body diagram and it is stated that it is deep and/or superficial.
In the second part, where the characteristics of pain are questioned, the words that best describe pain are marked, one from each box out of 20 boxes.
In this part, the sensory and perceptual dimensions of pain are evaluated.
The third section evaluates the time-dependent variation of pain.
In the fourth section, the severity of pain is measured comparatively.
The scoring ranges from 0 to 112.
A higher score indicates worsening of pain and related parameters.
Researchers will take two measurements, at the beginning and at the end of the intervention, to determine the change in pain parameters.
|
4 weeks
|
Notthingam Health Profile Questionnaire (NHP)
Time Frame: 4 weeks
|
It is a valid and reliable scale that measures general health status in musculoskeletal disorders and chronic diseases.
It questions the well-being of individuals in physical, emotional and social areas.
The first part consists of 38 questions and six subheadings: pain, emotional reactions, sleep, social isolation, physical activity and energy level.
In the second part, it is evaluated to what extent the limitations experienced by individuals in their daily activities due to their health status affect their quality of life.
The first part score is calculated between 0-600 points, with a maximum of 100 points for each sub-title, and the second part is calculated between 0-7 points.
High scores indicate low quality of life.
Researchers will take two measurements, at the beginning and at the end of the intervention, to determine the change in quality of life.
|
4 weeks
|
Female Sexual Function Index (FSFI)
Time Frame: 4 weeks
|
It is a 5-point Likert-type scale consisting of 19 items and 6 sub-parameters.
It evaluates many parameters such as frequency and level of sexual desire, level of arousal, frequency and difficulty of lubrication, ability to maintain lubrication, frequency and difficulty of orgasm, emotional intimacy in sexual intercourse, satisfaction with sexual life, pain during sexual intercourse.
The first two questions are calculated between 1-5 points and the other questions between 0-5 points.
When the raw scores are multiplied by the coefficients, the highest possible score is 36.0 and the lowest score is 2.0.
A high score means that sexual functions are good.
The cut-off value of the scale is 26.55.
Researchers will take two measurements, at the beginning and at the end of the intervention, to determine the change in female sexual functions.
|
4 weeks
|
Bristol Female Lower Urinary System Symptom Index (BFLUSSI)
Time Frame: 4 weeks
|
It was developed to evaluate female lower urinary tract symptoms, their severity, and the effects of these symptoms on quality of life and sexual functions.
It consists of 34 Likert type questions.
19 questions assess mixing functions, 4 questions assess sexual functions and 11 questions assess quality of life.
It consists of 5 sub-parameters, these are storage (questions 1-4), urination (questions 5-7), incontinence (questions 8-12), sexual life (questions 13-14) and quality of life (questions 15-19).
Scoring is between 0.71.
A high score indicates worsening of lower urinary tract symptoms.
Researchers will take two measurements, at the beginning and at the end of the intervention, to determine the change in lower urinary system symptoms.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 20, 2023
Primary Completion (Actual)
March 27, 2023
Study Completion (Actual)
March 31, 2023
Study Registration Dates
First Submitted
March 10, 2023
First Submitted That Met QC Criteria
March 28, 2023
First Posted (Actual)
March 29, 2023
Study Record Updates
Last Update Posted (Actual)
April 5, 2023
Last Update Submitted That Met QC Criteria
April 4, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SenaOndes1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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