Chronic Pelvic Pain SyndromeNCT05788653
Comparison of Different Massages Tecniques on Chronic Pelvic Pain
A study testing Thiele Massage and Transverse Friction Massage in people with Chronic Pelvic Pain Syndrome, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Chronic Pelvic Pain Syndrome
- What is being tested?
- Thiele Massage and Transverse Friction Massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2023to 31 Mar 2023
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis of Pelvic floor muscle tenderness, Clinical Diagnosis of Chronic Pelvic Pain Syndrome
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Pelvic Pain Syndrome
- Being tested
- Thiele Massage, Transverse Friction Massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiele MassageProcedure or surgery
Transvaginal Massage
Transverse Friction MassageProcedure or surgery
Transvaginal Massage
| Study group | Role | What they receive |
|---|---|---|
| Thiele Group | Active comparator | 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. Receives: Procedure: Thiele Massage |
| Transverse Friction Group | Active comparator | 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. Receives: Procedure: Transverse Friction Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
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.
Measured: 4 weeks
McGill Melzack Pain Questionnaire (MMPQ)
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.
Measured: 4 weeks
Notthingam Health Profile Questionnaire (NHP)
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.
Measured: 4 weeks
Female Sexual Function Index (FSFI)
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.
Measured: 4 weeks
Bristol Female Lower Urinary System Symptom Index (BFLUSSI)
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.
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 posted29 Mar 2023
- Study start20 Feb 2023
- Primary completion27 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic Pain SyndromeStudies 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Öndeş, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788653
- Sponsor's protocol ID
- SenaOndes1
- Status last verified
- Apr 2023
- First submitted
- 10 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Transverse Friction Massage and Thiele Massage in Female Patients With Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT05788653
- Acronym / sponsor ID
- SenaOndes1
- Conditions
- Chronic Pelvic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 29 Mar 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thiele Group | Active comparator | Procedure: Thiele MassageThe 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. |
| Transverse Friction Group | Active comparator | Procedure: Transverse Friction MassageThe 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical Diagnosis of Pelvic floor muscle tenderness, Clinical Diagnosis of Chronic Pelvic Pain Syndrome
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Thiele MassageTransvaginal Massage | Procedure or surgery | Thiele Group |
| Transverse Friction MassageTransvaginal Massage | Procedure or surgery | Transverse Friction Group |
Primary outcome
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.
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.
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.
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.
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.
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 5 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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 Thiele Massage and Transverse Friction Massage in people with Chronic Pelvic Pain Syndrome, run by Atlas University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 5 Apr 2023. 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 Turkey (Türkiye). 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?
Visual Analog Scale (VAS) (time frame: 4 weeks). The study lists 5 primary outcomes in all. 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 5 Apr 2023.