Pelvic PainCPPNCT05698355
Telerehabilitation in Chronic Pelvic Pain
A study testing Telerehabilitation Treatment in people with Pelvic Pain and Telerehabilitation, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Objective: Physical therapists utilize telerehabilitation as the common term for telehealth applications. Many physiotherapists worked as telehealth providers during the coronavirus pandemic. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Pain, Telerehabilitation, Pelvic Floor; Relaxation
- What is being tested?
- Telerehabilitation Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jan 2023to 10 Sep 2024
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- experienced pelvic pain (dyspareunia) for over six (6) months prior to the study
- to be able to use the internet and their willingness to participate.
- no pelvic floor surgeries
- no C-section and birth history
- to have a diagnoses by dyspareunia
Who cannot join
- to have endometriosis
- to have a pelvic health physiotherapy history
- pelvic organ prolapse, or a previous pelvic organ surgery.
- the use of analgesics in the previous three (3) months,
- to have a pregnancy,
- to have an active vaginal or urinary tract infection, or suffering from other comorbidities that affect the lower urinary tract such as diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alime Buyuk
Antalya, Select State / Province...a
About this study
Objective: Physical therapists utilize telerehabilitation as the common term for telehealth applications. Many physiotherapists worked as telehealth providers during the coronavirus pandemic. The objective of the study will show the efficacy of Telerehabilitation-Based Physical Therapy (TBPT) on pain intensity and treatment satisfaction in patients with chronic pelvic pain.
Method: This study is a prospective study of patients with chronic pelvic pain.42 participants will include the study. Patients who have any other distribution pattern of pelvic pain were equally considered for therapy. Women age between 18-50 years will be include. Their symptoms should be one of these follows such as chronic pain in pelvic region, hyperalgesia in vulva, and pain during sitting or intercourse. They will get diagnosed by a gynecologist who is a multidisciplinary team comprising and referred to a pelvic health physiotherapist. Prior to treatment patients will complete questionnaires and interview a pelvic health physiotherapist. Pain symptoms will be assessed with the Visual Analog Scale (VAS) and The Pelvic Pain Impact Questionnaire (PPIQ) before and after treatment. Patient Global Impression of Improvement (PGI-I) for evaluating patient satisfaction after treatment. Women with chronic pelvic pain will be treated for 16 sessions (an hour for each session) in 8 weeks with the TBPT technique by the same pelvic health physiotherapist (AB). Patients will apply internal and external trigger point release therapy and self-massage techniques by themselves with Telerehabilitation-Based Physical Therapy.
Read the detailed description
Telerehabilitation is described as the remote conveyance of healthcare services and clinical information using information and telecommunication technologies involving the internet, wireless satellite, and telephone media to provide a series of rehabilitation services by eliminating the barriers of distance, time, and travel to receive care. There is an abundance of commercially available applications (such as Zoom) offered for health care monitoring and management. Most of the studies have employed telerehabilitation methods with patients who have pain, mainly for assessment or exercise programs. There is not any study on the telerehabilitation application of physical therapy in patients with chronic pelvic pain during the coronavirus pandemic.
Our conceptual framework is based on two arguments. First, physiotherapists need physical access to their patients only for a limited number of interventions. Most of the methods used by physiotherapists to treat their patients can be conducted at a distance without having direct access to the patient. Previous studies have shown that telerehabilitation can be used in many cases and provide results on par with face-to-face treatment. In fact, self-administered treatment was found to be effective even in the case of postal treatment where the participants received instruction through postal systems.
Second, the pelvic floor area is relatively well-suited for self-treatment. Most, if not all, of the exercises and procedures, can be safely conducted by the patients themselves. The patients can even use pelvic wands and dilators for harder-to-reach inner release points. Therefore, training the patient and supervising and guiding self-administered procedures should be sufficiently effective to reduce pelvic pain and reach patient satisfaction in most cases.
The aim of the study will show the efficacy of Telerehabilitation-Based Physical Therapy (TBPT) on pain intensity and treatment satisfaction in patients with chronic pelvic pain.
- Conditions
- Pelvic Pain, Telerehabilitation, Pelvic Floor; Relaxation
- Being tested
- Telerehabilitation Treatment
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation TreatmentOther
Telerehabilitation includes self-massages for pelvic floor muscle, sex education, breathing, myofascial releasing with wand, and pelvic floor relaxing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group | Experimental | Multimodal self-treatment-based telerehabilitation will be implemented with a video conference method. For telerehabilitation, at each session, manual therapy techniques, (i.e., stretching, myofascial release, and tissue desensitization), sex education, and pelvic floor muscle relaxation massages with a pelvic wand (i.e., relaxation, stretching) using small intra-vaginal wand were used. Women were also asked to perform home exercises resembling those performed under supervision five times per week as well as auto-insertion exercises with a pelvic wand in addition to desensitization techniques three times per week.
Sessions consist of 60 minutes. Telerehabilitation will take place 2 days a week for 12 weeks. Receives: Other: Telerehabilitation Treatment |
| Education group | No intervention | 60 minutes of video recording training will be given about pelvic pain relaxation exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Pain Impact Questionnaire
The Pelvic Pain Impact Questionnaire is a questionnaire composed of eight (8) questions. The patient is asked to grade how pelvic pain has affected various activities on a 5-point Likert scale. The total score is obtained by adding the scores given for each item, a high score is directly proportional to the severity of pain.
Measured: 1-3 monts
VAS
The VAS is frequently used in cases where rapid measurement of pain intensity is required in clinical and laboratory conditions. It consists of drawing a line from zero (0) to ten (10) and ask the patient to mark the pain intensity on the line where zero (0) means "I have no pain" and ten (10) means "the most severe pain possible".
Measured: 1-3 months
The Female Sexual Function Index
The Female Sexual Function Index is a brief multidimensional scale for assessing sexual function in women. The scale has received initial psychometric evaluation, including studies of reliability, convergent validity, and discriminant validity
Measured: 1-3 months
The Female Sexual Distress Scale-Revised
The Female Sexual Distress Scale-Revised was used to assess sexual distress, with higher scores relating to more sexual distress
Measured: 1-3 months
Vaginal Penetration Cognition Questionnaire
To assess cognition regarding vaginal penetration in women with vaginismus or dyspareunia
Measured: 1-3 months
Secondary outcomes (1)
The Patient Global Impression of Change
The Patient Global Impression of Change allowed the participants to self-report their perceived improvement (categories ranging from very much improved to very much worse). The PGI-I requires the patient to grade on a seven (7) point likert scale how the condition has evolved compared to how it was prior to the treatment. All questionnaires have validity and reliability in Turkish language .
Measured: 1-3 motnhs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start16 Jan 2023
- Primary completion16 Jan 2023
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alime Buyuk, Akdeniz University
- Investigators
- Alime Buyuk, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698355
- Sponsor's protocol ID
- Akdeniz
- Acronym
- CPP
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Padoa A, McLean L, Morin M, Vandyken C. The Overactive Pelvic Floor (OPF) and Sexual Dysfunction. Part 2: Evaluation and Treatment of Sexual Dysfunction in OPF Patients. Sex Med Rev. 2021 Jan;9(1):76-92. doi: 10.1016/j.sxmr.2020.04.002. Epub 2020 Jul 4.
PubMed 32631813Morin M, Dumoulin C, Bergeron S, Mayrand MH, Khalife S, Waddell G, Dubois MF; PVD Study Group. Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a multicenter, randomized trial. Am J Obstet Gynecol. 2021 Feb;224(2):189.e1-189.e12. doi: 10.1016/j.ajog.2020.08.038. Epub 2020 Aug 18.
PubMed 32818475Cyr MP, Dostie R, Camden C, Dumoulin C, Bessette P, Pina A, Gotlieb WH, Lapointe-Milot K, Mayrand MH, Morin M. Improvements following multimodal pelvic floor physical therapy in gynecological cancer survivors suffering from pain during sexual intercourse: Results from a one-year follow-up mixed-method study. PLoS One. 2022 Jan 25;17(1):e0262844. doi: 10.1371/journal.pone.0262844. eCollection 2022.
PubMed 35077479Cyr MP, Dumoulin C, Bessette P, Pina A, Gotlieb WH, Lapointe-Milot K, Mayrand MH, Morin M. Feasibility, acceptability and effects of multimodal pelvic floor physical therapy for gynecological cancer survivors suffering from painful sexual intercourse: A multicenter prospective interventional study. Gynecol Oncol. 2020 Dec;159(3):778-784. doi: 10.1016/j.ygyno.2020.09.001. Epub 2020 Oct 1.
PubMed 33010968
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation in Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT05698355
- Acronym / sponsor ID
- CPP / Akdeniz
- Conditions
- Pelvic Pain, Telerehabilitation, Pelvic Floor; Relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 26 Jan 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.
Objective: Physical therapists utilize telerehabilitation as the common term for telehealth applications. Many physiotherapists worked as telehealth providers during the coronavirus pandemic. The objective of the study will show the efficacy of Telerehabilitation-Based Physical Therapy (TBPT) on pain intensity and treatment satisfaction in patients with chronic pelvic pain.
Method: This study is a prospective study of patients with chronic pelvic pain.42 participants will include the study. Patients who have any other distribution pattern of pelvic pain were equally considered for therapy. Women age between 18-50 years will be include. Their symptoms should be one of these follows such as chronic pain in pelvic region, hyperalgesia in vulva, and pain during sitting or intercourse. They will get diagnosed by a gynecologist who is a multidisciplinary team comprising and referred to a pelvic health physiotherapist. Prior to treatment patients will complete questionnaires and interview a pelvic health physiotherapist. Pain symptoms will be assessed with the Visual Analog Scale (VAS) and The Pelvic Pain Impact Questionnaire (PPIQ) before and after treatment. Patient Global Impression of Improvement (PGI-I) for evaluating patient satisfaction after treatment. Women with chronic pelvic pain will be treated for 16 sessions (an hour for each session) in 8 weeks with the TBPT technique by the same pelvic health physiotherapist (AB). Patients will apply internal and external trigger point release therapy and self-massage techniques by themselves with Telerehabilitation-Based Physical Therapy.
Detailed description
Telerehabilitation is described as the remote conveyance of healthcare services and clinical information using information and telecommunication technologies involving the internet, wireless satellite, and telephone media to provide a series of rehabilitation services by eliminating the barriers of distance, time, and travel to receive care. There is an abundance of commercially available applications (such as Zoom) offered for health care monitoring and management. Most of the studies have employed telerehabilitation methods with patients who have pain, mainly for assessment or exercise programs. There is not any study on the telerehabilitation application of physical therapy in patients with chronic pelvic pain during the coronavirus pandemic.
Our conceptual framework is based on two arguments. First, physiotherapists need physical access to their patients only for a limited number of interventions. Most of the methods used by physiotherapists to treat their patients can be conducted at a distance without having direct access to the patient. Previous studies have shown that telerehabilitation can be used in many cases and provide results on par with face-to-face treatment. In fact, self-administered treatment was found to be effective even in the case of postal treatment where the participants received instruction through postal systems.
Second, the pelvic floor area is relatively well-suited for self-treatment. Most, if not all, of the exercises and procedures, can be safely conducted by the patients themselves. The patients can even use pelvic wands and dilators for harder-to-reach inner release points. Therefore, training the patient and supervising and guiding self-administered procedures should be sufficiently effective to reduce pelvic pain and reach patient satisfaction in most cases.
The aim of the study will show the efficacy of Telerehabilitation-Based Physical Therapy (TBPT) on pain intensity and treatment satisfaction in patients with chronic pelvic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Experimental | Other: Telerehabilitation TreatmentMultimodal self-treatment-based telerehabilitation will be implemented with a video conference method. For telerehabilitation, at each session, manual therapy techniques, (i.e., stretching, myofascial release, and tissue desensitization), sex education, and pelvic floor muscle relaxation massages with a pelvic wand (i.e., relaxation, stretching) using small intra-vaginal wand were used. Women were also asked to perform home exercises resembling those performed under supervision five times per week as well as auto-insertion exercises with a pelvic wand in addition to desensitization techniques three times per week. Sessions consist of 60 minutes. Telerehabilitation will take place 2 days a week for 12 weeks. |
| Education group | No intervention | –60 minutes of video recording training will be given about pelvic pain relaxation exercises. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- experienced pelvic pain (dyspareunia) for over six (6) months prior to the study
- to be able to use the internet and their willingness to participate.
- no pelvic floor surgeries
- no C-section and birth history
- to have a diagnoses by dyspareunia
Key exclusion criteria (6 listed)
- to have endometriosis
- to have a pelvic health physiotherapy history
- pelvic organ prolapse, or a previous pelvic organ surgery.
- the use of analgesics in the previous three (3) months,
- to have a pregnancy,
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 |
|---|---|---|
| Telerehabilitation TreatmentTelerehabilitation includes self-massages for pelvic floor muscle, sex education, breathing, myofascial releasing with wand, and pelvic floor relaxing exercises. | Other | Telerehabilitation group |
Primary outcome
Pelvic Pain Impact Questionnaire
Time frame: 1-3 monts
The Pelvic Pain Impact Questionnaire is a questionnaire composed of eight (8) questions. The patient is asked to grade how pelvic pain has affected various activities on a 5-point Likert scale. The total score is obtained by adding the scores given for each item, a high score is directly proportional to the severity of pain.
VAS
Time frame: 1-3 months
The VAS is frequently used in cases where rapid measurement of pain intensity is required in clinical and laboratory conditions. It consists of drawing a line from zero (0) to ten (10) and ask the patient to mark the pain intensity on the line where zero (0) means "I have no pain" and ten (10) means "the most severe pain possible".
The Female Sexual Function Index
Time frame: 1-3 months
The Female Sexual Function Index is a brief multidimensional scale for assessing sexual function in women. The scale has received initial psychometric evaluation, including studies of reliability, convergent validity, and discriminant validity
The Female Sexual Distress Scale-Revised
Time frame: 1-3 months
The Female Sexual Distress Scale-Revised was used to assess sexual distress, with higher scores relating to more sexual distress
Vaginal Penetration Cognition Questionnaire
Time frame: 1-3 months
To assess cognition regarding vaginal penetration in women with vaginismus or dyspareunia
1 secondary outcome
The Patient Global Impression of Change
Time frame: 1-3 motnhs
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 29 Jan 2025.
- Background: PubMed 32631813Padoa A, McLean L, Morin M, Vandyken C. The Overactive Pelvic Floor (OPF) and Sexual Dysfunction. Part 2: Evaluation and Treatment of Sexual Dysfunction in OPF Patients. Sex Med Rev. 2021 Jan;9(1):76-92. doi: 10.1016/j.sxmr.2020.04.002. Epub 2020 Jul 4.
- Background: PubMed 32818475Morin M, Dumoulin C, Bergeron S, Mayrand MH, Khalife S, Waddell G, Dubois MF; PVD Study Group. Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a multicenter, randomized trial. Am J Obstet Gynecol. 2021 Feb;224(2):189.e1-189.e12. doi: 10.1016/j.ajog.2020.08.038. Epub 2020 Aug 18.
- Background: PubMed 35077479Cyr MP, Dostie R, Camden C, Dumoulin C, Bessette P, Pina A, Gotlieb WH, Lapointe-Milot K, Mayrand MH, Morin M. Improvements following multimodal pelvic floor physical therapy in gynecological cancer survivors suffering from pain during sexual intercourse: Results from a one-year follow-up mixed-method study. PLoS One. 2022 Jan 25;17(1):e0262844. doi: 10.1371/journal.pone.0262844. eCollection 2022.
- Background: PubMed 33010968Cyr MP, Dumoulin C, Bessette P, Pina A, Gotlieb WH, Lapointe-Milot K, Mayrand MH, Morin M. Feasibility, acceptability and effects of multimodal pelvic floor physical therapy for gynecological cancer survivors suffering from painful sexual intercourse: A multicenter prospective interventional study. Gynecol Oncol. 2020 Dec;159(3):778-784. doi: 10.1016/j.ygyno.2020.09.001. Epub 2020 Oct 1.
- Individual participant dataSharing planned: No
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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.
Alime Buyuk principal investigator
Akdeniz 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 Telerehabilitation Treatment in people with Pelvic Pain and Telerehabilitation, run by Akdeniz 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 5 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 29 Jan 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 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?
Pelvic Pain Impact Questionnaire (time frame: 1-3 monts). 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?
On the ClinicalTrials.gov record for NCT05698355, which also lists 4 linked publications.
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 29 Jan 2025.