Provoked VestibulodyniaLLLTNCT01149031
Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia
A study testing LOW LEVEL LASER SYSTEM in people with Provoked Vestibulodynia, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Provoked vestibulodynia, previously called vulvar vestibulitis syndrome, is clinically defined as chronic, unexplained, vulvar pain or discomfort confined to the vulvar vestibule in response to contact or pressure. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Provoked Vestibulodynia
- What is being tested?
- LOW LEVEL LASER SYSTEM
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Dec 2013
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with provoked vestibulodynia who meet modified Friedrich's criteria, after exclusion of other vulvar disorders, who are willing to participate in the study.
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Provoked vestibulodynia, previously called vulvar vestibulitis syndrome, is clinically defined as chronic, unexplained, vulvar pain or discomfort confined to the vulvar vestibule in response to contact or pressure. In addition, many patients also have pain in response to non-sexual activities such as tampon insertion, gynecological examinations or physical pursuits such as bicycle riding; the severity of other vulvo-vaginal symptoms such as itching, burning and irritation varies. Once women with provoked vestibulodynia develop the syndrome, symptoms may last for months or years; as a result, provoked vestibulodynia has a profound effect on women's sexuality and psychological well-being. The diagnosis of provoked vestibulodynia is usually made by ascertaining if the patient fulfills modified Friedrich's criteria, consisting of 1) a history of vulvar pain, dyspareunia or pain with tampon insertion, 2) tenderness of the vestibule when being touched with a cotton-tip applicator and 3) no identifiable cause for the pain.
The etiology of this condition remains unknown. Proposed causes include chronic inflammation, peripheral neuropathy, genetic, immunologic and hormonal factors, infectious, psychological disorders, sexual dysfunction or disturbance in the central nervous system. Because the cause of provoked vestibulodynia remains unknown, many different treatments have been described for this condition, including topical and intra-lesional corticosteroids, topical anesthetics such as lidocaine, topical estrogen, topical or oral antidepressants or anti-convulsants, biofeedback or physical therapy, surgical resection of the involved tissue (vestibulectomy) and a variety of complementary and alternative therapies.
Read more
Low level laser therapy (LLLT) is an emerging medical technique in which exposure to low-level laser light or light emitting diodes might stimulate or inhibit cellular function, possibly leading to beneficial clinical effects. Clinical applications that show some potential of effectiveness include treating soft tissue injury, chronic pain, and wound healing. The usage of low level laser therapy was found effective in various pain syndromes, and has no side effects.
Since inflammatory mechanisms have been proposed in the pathogenesis of provoked vestibulodynia, and as there is no effective therapy for this syndrome, the investigators intend to study whether low level laser therapy might be an effective therapy for provoked vestibulodynia.
- Conditions
- Provoked Vestibulodynia
- Being tested
- LOW LEVEL LASER SYSTEM
- Keywords
- Provoked Vestibulodynia, Low Level Laser Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOW LEVEL LASER SYSTEMDevice
Also called LASER DIODE CLASS 3B,OMEGA XP
LASER DIODE CLASS 3B,OMEGA XP
| Study group | Role | What they receive |
|---|---|---|
| low level laser therapy, using a probe | Active comparator | The treatment will be done by using a LLL-probe touching several areas of the vulvar vestibule, according to the selected protocol.
Every patient will be treated twice weekly for 6 weeks. Receives: Device: LOW LEVEL LASER SYSTEM |
| Placebo | Placebo comparator | The patients will be treated with placebo-probe, according to the same protocol Receives: Device: LOW LEVEL LASER SYSTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vestibular pain level(as measured by variable parameters)
Response to treatment will be assessed by change in pain by numeric rating scale of a weekly Tampon Test, change in overall daily pain intensity (24 hour numeric rating scale), frequency of sexual intercourse, the change in intercourse pain numeric rating scale, and the cotton swab test pain level by verbal reporting scale. In addition, patients will complete quality-of-life questionnaires (Brief Pain Inventory and Neuropathic Pain Scale)
Measured: 7 weeks (at the end of treatment protocol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Provoked VestibulodyniaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahinoam Lev-Sagie, Hadassah Medical Organization
- Investigators
- Ahinoam Lev-Sagie, MD, Principal investigator, Hadassah Medical Organization, Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149031
- Sponsor's protocol ID
- ahinoam110-HMO-CTIL
- Acronym
- LLLT
- Status last verified
- Mar 2015
- First submitted
- 16 Jun 2010
- Last updated
- 24 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia
- ClinicalTrials.gov ID
- NCT01149031
- Acronym / sponsor ID
- LLLT / ahinoam110-HMO-CTIL
- Conditions
- Provoked Vestibulodynia
- Keywords
- Provoked Vestibulodynia, Low Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Jun 2010 (estimated)
- 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.
Provoked vestibulodynia, previously called vulvar vestibulitis syndrome, is clinically defined as chronic, unexplained, vulvar pain or discomfort confined to the vulvar vestibule in response to contact or pressure. In addition, many patients also have pain in response to non-sexual activities such as tampon insertion, gynecological examinations or physical pursuits such as bicycle riding; the severity of other vulvo-vaginal symptoms such as itching, burning and irritation varies. Once women with provoked vestibulodynia develop the syndrome, symptoms may last for months or years; as a result, provoked vestibulodynia has a profound effect on women's sexuality and psychological well-being. The diagnosis of provoked vestibulodynia is usually made by ascertaining if the patient fulfills modified Friedrich's criteria, consisting of 1) a history of vulvar pain, dyspareunia or pain with tampon insertion, 2) tenderness of the vestibule when being touched with a cotton-tip applicator and 3) no identifiable cause for the pain.
The etiology of this condition remains unknown. Proposed causes include chronic inflammation, peripheral neuropathy, genetic, immunologic and hormonal factors, infectious, psychological disorders, sexual dysfunction or disturbance in the central nervous system. Because the cause of provoked vestibulodynia remains unknown, many different treatments have been described for this condition, including topical and intra-lesional corticosteroids, topical anesthetics such as lidocaine, topical estrogen, topical or oral antidepressants or anti-convulsants, biofeedback or physical therapy, surgical resection of the involved tissue (vestibulectomy) and a variety of complementary and alternative therapies.
Low level laser therapy (LLLT) is an emerging medical technique in which exposure to low-level laser light or light emitting diodes might stimulate or inhibit cellular function, possibly leading to beneficial clinical effects. Clinical applications that show some potential of effectiveness include treating soft tissue injury, chronic pain, and wound healing. The usage of low level laser therapy was found effective in various pain syndromes, and has no side effects.
Since inflammatory mechanisms have been proposed in the pathogenesis of provoked vestibulodynia, and as there is no effective therapy for this syndrome, the investigators intend to study whether low level laser therapy might be an effective therapy for provoked vestibulodynia.
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 |
|---|---|---|
| low level laser therapy, using a probe | Active comparator | Device: LOW LEVEL LASER SYSTEMThe treatment will be done by using a LLL-probe touching several areas of the vulvar vestibule, according to the selected protocol. Every patient will be treated twice weekly for 6 weeks. |
| Placebo | Placebo comparator | Device: LOW LEVEL LASER SYSTEMThe patients will be treated with placebo-probe, according to the same protocol |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with provoked vestibulodynia who meet modified Friedrich's criteria, after exclusion of other vulvar disorders, who are willing to participate in the study.
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| LOW LEVEL LASER SYSTEMAlso: LASER DIODE CLASS 3B,OMEGA XPLASER DIODE CLASS 3B,OMEGA XP | Device | Placebo, low level laser therapy, using a probe |
Primary outcome
Change in vestibular pain level(as measured by variable parameters)
Time frame: 7 weeks (at the end of treatment protocol)
Response to treatment will be assessed by change in pain by numeric rating scale of a weekly Tampon Test, change in overall daily pain intensity (24 hour numeric rating scale), frequency of sexual intercourse, the change in intercourse pain numeric rating scale, and the cotton swab test pain level by verbal reporting scale. In addition, patients will complete quality-of-life questionnaires (Brief Pain Inventory and Neuropathic Pain Scale)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
Related trials for Provoked Vestibulodynia
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Rigid Hymenal Ring as a Cause for Insertional Dyspareunia
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Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse
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Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health
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IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction
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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.
Ahinoam Lev-Sagie, MD principal investigator
Hadassah Medical Organization, Jerusalem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOW LEVEL LASER SYSTEM in people with Provoked Vestibulodynia, run by Hadassah Medical Organization at 1 site in Israel.
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: stopped early, as of the sponsor's last update on 24 Mar 2015. 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 Israel. 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?
The study was stopped early. 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?
Change in vestibular pain level(as measured by variable parameters) (time frame: 7 weeks (at the end of treatment protocol)). 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 24 Mar 2015.