EndometriosisNCT04012034
Treatment With Radiofrequency in Patients With Chronic Pelvic Pain and History of Endometriosis
A study testing Radiofrequency A and Radiofrequency B in people with Endometriosis and Chronic Pain, run by Hospital Clinic of Barcelona at 2 sites in Spain.
Trial summary
Managing chronic pelvic pain in patients with a past history of endometriosis might be a challenge for the gynaecologist. The objective of this study is to evaluate pelvic pain after treatment with radiofrequency in patients with chronic pelvic pain and surgery for endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Chronic Pain, Quality of Life
- What is being tested?
- Radiofrequency A and Radiofrequency B
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesSpain
- Study dates
- 21 Feb 2019to 30 May 2022
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Chronic pelvic pain
- Past surgery for endometriosis
Who cannot join
- Active endometriosis, diagnosed by imaging techniques
- Presence of other diseases that can cause chronic pelvic pain
- Contraindication for the radiofrequency use: pregnancy, metallic prothesis
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Treatment With Punction and Radiofrequency of Active Trigger Points in Patients With Pelvic Chronic Pain and History of Endometriosis
Managing chronic pelvic pain in patients with a past history of endometriosis might be a challenge for the gynaecologist.
The objective of this study is to evaluate pelvic pain after treatment with radiofrequency in patients with chronic pelvic pain and surgery for endometriosis.
Read the detailed description
Patients with pelvic chronic pain and a past history of endometriosis without imaging evidence of endometriosis in the present will be enrolled in this study. The main objective of this study is to evaluate improvement of pelvic pain these patients. Moreover, quality of life and sexual function will be also assessed. Patients who are enrolled will come once a week per eight weeks to the hospital to have 30 minutes treatment with radiofrequency. They will be randomised in two groups, one receiving the radiofrequency and the other not (the device will be not give the energy). At the enrollement visit, the SF-36, VAS score, anxiety and depression tests and sexual function tests will be answered the patients. At the end of the treatment, and one month after the end, they will answer the same questionnaires.
- Conditions
- Endometriosis, Chronic Pain, Quality of Life
- Being tested
- Radiofrequency A, Radiofrequency B
- Medical subject headings
- Endometriosis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ADevice
Application of radiofrequency for 30 minutes per week during 8 weeks
Radiofrequency BDevice
Application of radiofrequency without energy for 30 minutes per week during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency A | Experimental | Treatment with radiofrequency Receives: Device: Radiofrequency A |
| Placebo | Placebo comparator | Treatment with radiofrequency without energy Receives: Device: Radiofrequency B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain: VAS score
Visual Analogue Scale Score, from 0 to 10, where 0 is no pain at all and 10 is the worst pain ever.
Measured: Baseline (Before starting the study)
Pain: VAS score
Visual Analogue Scale Score, from 0 to 10, where 0 is no pain at all and 10 is the worst pain ever.
Measured: 1 month after study completion
Secondary outcomes (4)
Quality of life: QoL SF-36
QoL SF-36, scale where 0 is maximum disability and a score of 100 is equivalent to no disability
Measured: Before starting the study
Quality of life: QoL SF-36
QoL SF-36, scale where 0 is maximum disability and a score of 100 is equivalent to no disability
Measured: 1 month after study completion
Female Sexual Function Index (FSFI)
Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all
Measured: Before starting the study
Female Sexual Function Index (FSFI)
Female Sexual Function Index (FSFI), minimum score is 2 and maximum score is 36, meaning no disfunction at all
Measured: 1 month after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start21 Feb 2019
- Primary completionFeb 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Carmona, Hospital Clinic of Barcelona
- Investigators
- Francisco Carmona, MD, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012034
- Sponsor's protocol ID
- RFDP
- Status last verified
- Mar 2021
- First submitted
- 25 May 2019
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not intended to share IPD to other researchers since it is the first study of this kind in our setting.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Punction and Radiofrequency of Active Trigger Points in Patients With Pelvic Chronic Pain and History of Endometriosis
- ClinicalTrials.gov ID
- NCT04012034
- Acronym / sponsor ID
- RFDP
- Conditions
- Endometriosis, Chronic Pain, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 9 Jul 2019 (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.
Managing chronic pelvic pain in patients with a past history of endometriosis might be a challenge for the gynaecologist.
The objective of this study is to evaluate pelvic pain after treatment with radiofrequency in patients with chronic pelvic pain and surgery for endometriosis.
Detailed description
Patients with pelvic chronic pain and a past history of endometriosis without imaging evidence of endometriosis in the present will be enrolled in this study. The main objective of this study is to evaluate improvement of pelvic pain these patients. Moreover, quality of life and sexual function will be also assessed. Patients who are enrolled will come once a week per eight weeks to the hospital to have 30 minutes treatment with radiofrequency. They will be randomised in two groups, one receiving the radiofrequency and the other not (the device will be not give the energy). At the enrollement visit, the SF-36, VAS score, anxiety and depression tests and sexual function tests will be answered the patients. At the end of the treatment, and one month after the end, they will answer the same questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency A | Experimental | Device: Radiofrequency ATreatment with radiofrequency |
| Placebo | Placebo comparator | Device: Radiofrequency BTreatment with radiofrequency without energy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Chronic pelvic pain
- Past surgery for endometriosis
Key exclusion criteria (3 listed)
- Active endometriosis, diagnosed by imaging techniques
- Presence of other diseases that can cause chronic pelvic pain
- Contraindication for the radiofrequency use: pregnancy, metallic prothesis
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 |
|---|---|---|
| Radiofrequency AApplication of radiofrequency for 30 minutes per week during 8 weeks | Device | Radiofrequency A |
| Radiofrequency BApplication of radiofrequency without energy for 30 minutes per week during 8 weeks | Device | Placebo |
Primary outcome
Pain: VAS score
Time frame: Baseline (Before starting the study)
Visual Analogue Scale Score, from 0 to 10, where 0 is no pain at all and 10 is the worst pain ever.
Pain: VAS score
Time frame: 1 month after study completion
Visual Analogue Scale Score, from 0 to 10, where 0 is no pain at all and 10 is the worst pain ever.
4 secondary outcomes
Quality of life: QoL SF-36
Time frame: Before starting the study
Quality of life: QoL SF-36
Time frame: 1 month after study completion
Female Sexual Function Index (FSFI)
Time frame: Before starting the study
Female Sexual Function Index (FSFI)
Time frame: 1 month after study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: No. It is not intended to share IPD to other researchers since it is the first study of this kind in our setting.
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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.
Francisco Carmona, MD, PhD principal investigator
Hospital Clinic of Barcelona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency A and Radiofrequency B in people with Endometriosis and Chronic Pain, run by Hospital Clinic of Barcelona at 2 sites in Spain.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Pain: VAS score (time frame: Baseline (Before starting the study)). The study lists 2 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 19 Mar 2021.