Burning Mouth SyndromeEarly Phase 1ACUCLONBMSNCT02382029
Acupuncture Versus Clonazepam in Burning Mouth Syndrome
A Early Phase 1 study testing Clonazepam and acupuncture in people with Burning Mouth Syndrome, run by University of Zagreb.
Trial summary
Objective: Burning mouth syndrome (BMS) is chronic oral condition characterized with burning symptoms which affects perimenopausal and postmenopausal women. It seems that neuropathy might be the underlying cause of the condition. There are still insufficient data regarding successful therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burning Mouth Syndrome
- What is being tested?
- Clonazepam and acupuncture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Nov 2014
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of burning mouth syndrome Clinically normal appearance of oral mucosa Must be able to swallow tablets
Who cannot join
- Oral mucosal lesions Anemia
About this study
Official title: The Effectiveness of Acupuncture Versus Clonazepam in the Patients With Burning Mouth Syndrome
Objective: Burning mouth syndrome (BMS) is chronic oral condition characterized with burning symptoms which affects perimenopausal and postmenopausal women. It seems that neuropathy might be the underlying cause of the condition. There are still insufficient data regarding successful therapy. The aim of this study was to compare efficacy of acupuncture and clonazepam in 42 BMS patients (38 women, 4 men), age range 66.7±12 years.
Methods: Patients were randomly divided into two groups. Acupuncture was performed in group I during four weeks, 3 times per week on the points ST 8, GB 2, TB 21, SI 19, SI 18, LI 4 on both sides of the body as well as GV 20, each session lasted half an hour.Group II patients took clonazepam two times a day (0.5 mg) in the morning and after two weeks two tablets (0.5 mg) in the morning and in the evening during the next two weeks. Prior to and one month after either therapy, participants fulfilled questionnaires: visual analogue scale, Beck depression inventory, LANSS pain scale, 36-item short form Health Survey (SF-36) and Montreal Cognitive Assessment (MoCA). Statistical analysis was performed by use of Student t test and Pearson's correlation test. P values lower than 0.05 were considered significant.
Read the detailed description
This study was approved by Ethical Committee of the School of dentistry in Zagreb. Prior to the study every participant signed informed consent according to the Helsinki II. All patient were recruited from the Department of Oral medicine, School of dentistry in Zagreb.
Patients were randomized by simple randomization method- flipping a coin (heads - acupuncture, tails - clonazepam).
Inclusion criteria were symptoms of burning in the oral cavity with clinically healthy appearance of the oral mucosa. Burning symptoms were continuous throughout the day and lasted for more than 6 months. Some of the patients also had hyposalivation and disturbed taste.
Prior to the either therapy as well as after the therapy (one month after the therapy has finished) every participant fulfilled following questionnaires: visual analogue scale (VAS) which referred to the severity of burning symptoms, Beck depression inventory (BDI), The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale, 36-item short form Health Survey (SF-36) total sum score and Montreal Cognitive Assessment (MoCA).
Arm (I) traditional Chinese acupuncture - performed 3 times during one week for four weeks on the points ST 8 (stomach- tou wei), GB 2, TE 21, SI 19 (small intestine- ting gong), SI 18 (small intestine- quan liao), LI 4 (large intestine-Yuan) on both sides of the body as well as GV 20 (Governing vessel-bai hui) and each session lasted half an hour. We used sterile acupuncture needles from surgical stainless steel silicone coated with spring handle, the dimensiones of the chosen needles were 0.25 in diameter and 30 mm lenght, inserted at the depht of the 0.5-1 cun. The elicited response was of the type "de qi" accompanied by redness and a feeling of numbness around the needles.
Arm (II) Clonazepam - patients took clonazepam two times a day (0.5 mg) in the morning and after two weeks one tablet (0.5 mg) in the morning and another tablet (0.5 mg) in the evening during the next two weeks.
Statistical analysis was performed by use of Student t test and Pearson's correlation test. P values lower than 0.05 were considered significant.
- Conditions
- Burning Mouth Syndrome
- Being tested
- Clonazepam, acupuncture
- Medical subject headings
- Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonazepamDrug
Also called Rivotril
Active medical treatment for burning mouth syndrome
acupunctureOther
Traditional chinese acupuncture
| Study group | Role | What they receive |
|---|---|---|
| clonazepam | Active comparator | Twenty two patients took clonazepam two times a day (0.5 mg) in the morning and after two weeks one tablet (0.5 mg) in the morning and another tablet (0.5 mg) in the evening during the next two weeks. Receives: Drug: Clonazepam |
| acupuncture | Experimental | Traditional Chinese acupuncture was performed on 20 participants 3 times during one week for four weeks. Intervention was performed on acupuncture points as follows: the points ST 8 (stomach- tou wei), GB 2, TE 21, SI 19 (small intestine- ting gong), SI 18 (small intestine- quan liao), LI 4 (large intestine-Yuan) on both sides of the body as well as GV 20 (Governing vessel-bai hui).
Each session lasted half an hour. Sterile acupuncture needles made from surgical stainless steel silicone coated with spring handle were used. The dimensions of the chosen needles were 0.25 in diameter and 30 mm length, inserted at the depth of the 0.5-1 cm. The elicited response was of the type "de qi" accompanied by redness and a feeling of numbness around the needles. Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity measured by the visual analogue scale
Measured: 6 months
Secondary outcomes (4)
The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale
Assessment of neuropathic pain measured by validated instrument (LANSS pain scale)
Measured: 6 months
Cognitive function
Assesment of cognitive function measured by validated instrument ( MoCA cognitive test)
Measured: 6 months
Depression
Assesment of depressive symptoms by use of validated instrument (Beck Depression Inventory)
Measured: 6 months
Quality of life
Assesment of quality of life by validated instrument (Short Forma Health Survey: SF-36)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startMar 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burning Mouth 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanja Vucicevic Boras, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382029
- Sponsor's protocol ID
- UZagreb
- Acronym
- ACUCLONBMS
- Status last verified
- Mar 2015
- First submitted
- 13 Feb 2015
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Acupuncture Versus Clonazepam in the Patients With Burning Mouth Syndrome
- ClinicalTrials.gov ID
- NCT02382029
- Acronym / sponsor ID
- ACUCLONBMS / UZagreb
- Conditions
- Burning Mouth Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 6 Mar 2015 (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.
Objective: Burning mouth syndrome (BMS) is chronic oral condition characterized with burning symptoms which affects perimenopausal and postmenopausal women. It seems that neuropathy might be the underlying cause of the condition. There are still insufficient data regarding successful therapy. The aim of this study was to compare efficacy of acupuncture and clonazepam in 42 BMS patients (38 women, 4 men), age range 66.7±12 years.
Methods: Patients were randomly divided into two groups. Acupuncture was performed in group I during four weeks, 3 times per week on the points ST 8, GB 2, TB 21, SI 19, SI 18, LI 4 on both sides of the body as well as GV 20, each session lasted half an hour.Group II patients took clonazepam two times a day (0.5 mg) in the morning and after two weeks two tablets (0.5 mg) in the morning and in the evening during the next two weeks. Prior to and one month after either therapy, participants fulfilled questionnaires: visual analogue scale, Beck depression inventory, LANSS pain scale, 36-item short form Health Survey (SF-36) and Montreal Cognitive Assessment (MoCA). Statistical analysis was performed by use of Student t test and Pearson's correlation test. P values lower than 0.05 were considered significant.
Detailed description
This study was approved by Ethical Committee of the School of dentistry in Zagreb. Prior to the study every participant signed informed consent according to the Helsinki II. All patient were recruited from the Department of Oral medicine, School of dentistry in Zagreb.
Patients were randomized by simple randomization method- flipping a coin (heads - acupuncture, tails - clonazepam).
Inclusion criteria were symptoms of burning in the oral cavity with clinically healthy appearance of the oral mucosa. Burning symptoms were continuous throughout the day and lasted for more than 6 months. Some of the patients also had hyposalivation and disturbed taste.
Prior to the either therapy as well as after the therapy (one month after the therapy has finished) every participant fulfilled following questionnaires: visual analogue scale (VAS) which referred to the severity of burning symptoms, Beck depression inventory (BDI), The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale, 36-item short form Health Survey (SF-36) total sum score and Montreal Cognitive Assessment (MoCA).
Arm (I) traditional Chinese acupuncture - performed 3 times during one week for four weeks on the points ST 8 (stomach- tou wei), GB 2, TE 21, SI 19 (small intestine- ting gong), SI 18 (small intestine- quan liao), LI 4 (large intestine-Yuan) on both sides of the body as well as GV 20 (Governing vessel-bai hui) and each session lasted half an hour. We used sterile acupuncture needles from surgical stainless steel silicone coated with spring handle, the dimensiones of the chosen needles were 0.25 in diameter and 30 mm lenght, inserted at the depht of the 0.5-1 cun. The elicited response was of the type "de qi" accompanied by redness and a feeling of numbness around the needles.
Arm (II) Clonazepam - patients took clonazepam two times a day (0.5 mg) in the morning and after two weeks one tablet (0.5 mg) in the morning and another tablet (0.5 mg) in the evening during the next two weeks.
Statistical analysis was performed by use of Student t test and Pearson's correlation test. P values lower than 0.05 were considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clonazepam | Active comparator | Drug: ClonazepamTwenty two patients took clonazepam two times a day (0.5 mg) in the morning and after two weeks one tablet (0.5 mg) in the morning and another tablet (0.5 mg) in the evening during the next two weeks. |
| acupuncture | Experimental | Other: acupunctureTraditional Chinese acupuncture was performed on 20 participants 3 times during one week for four weeks. Intervention was performed on acupuncture points as follows: the points ST 8 (stomach- tou wei), GB 2, TE 21, SI 19 (small intestine- ting gong), SI 18 (small intestine- quan liao), LI 4 (large intestine-Yuan) on both sides of the body as well as GV 20 (Governing vessel-bai hui). Each session lasted half an hour. Sterile acupuncture needles made from surgical stainless steel silicone coated with spring handle were used. The dimensions of the chosen needles were 0.25 in diameter and 30 mm length, inserted at the depth of the 0.5-1 cm. The elicited response was of the type "de qi" accompanied by redness and a feeling of numbness around the needles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of burning mouth syndrome Clinically normal appearance of oral mucosa Must be able to swallow tablets
Key exclusion criteria (1 listed)
- Oral mucosal lesions Anemia
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 |
|---|---|---|
| ClonazepamAlso: RivotrilActive medical treatment for burning mouth syndrome | Drug | clonazepam |
| acupunctureTraditional chinese acupuncture | Other | acupuncture |
Primary outcome
Pain intensity
Time frame: 6 months
Pain intensity measured by the visual analogue scale
4 secondary outcomes
The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale
Time frame: 6 months
Cognitive function
Time frame: 6 months
Depression
Time frame: 6 months
Quality of life
Time frame: 6 months
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 6 Mar 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Clonazepam and acupuncture in people with Burning Mouth Syndrome, run by University of Zagreb.
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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain intensity (time frame: 6 months). 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 6 Mar 2015.