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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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.

Israel1 site
  • Ahinoam Lev-Sagie

    Jerusalem

Other trials in Israel

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.

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 groups in NCT01149031
Study groupRoleWhat they receive
low level laser therapy, using a probeActive comparatorThe 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
PlaceboPlacebo comparatorThe 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.

  1. 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.

  1. First posted23 Jun 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionOct 2012
  4. Study completionDec 2013

Resources

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)
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

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.

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