Burning Mouth Syndrome
Conditions
Keywords
BMS, Chronic pain, Pain-related disability, Somatosensory changes, clonazepam, capsaicin, oral mucosa
Brief summary
The first part of this study is to optimize diagnostic criteria for BMS, i.e. not a clinical trial, and will not be covered in this application. The second part will compare topical treatment with clonazepam, capsaicin and placebo in a n-of-1 study design regarding effects of pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience in patients with primary BMS or other oral mucosal pain. The patients will be treated for two weeks with each drug, with a one-week wash-out period in between. After the last washed-out period, the patients will be able to chose the treatment that they prefer the most and continue with that treatment during 6 months.
Detailed description
The clinical trial in the present study will investigate treatment effects on pain, pain-related disability, jaw function and patients' experiences by topical treatment with clonazepam or capsaicin in comparison with placebo in patients with BMS or other oral mucosal pain. Twenty patients with primary BMS and 20 patients with other oral mucosal pain will be included. The study will comprise a n-of-1-design where each participant will be it's own control. The study will compare topical treatment with clonazepam, capsaicin and placebo regarding effects of pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience. primary outcome will be pain intensity and patient experience. The patients will be treated for two weeks with each drug, with a one-week wash-out period in between. After the last washed-out period, the patients will be able to chose the treatment that they prefer the most and continue with that treatment during 6 months. After this 6 months, pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience will be assessed again.
Interventions
Topical treatment of oral mucosa with lozenge pill
Topical treatment of oral mucosa with capsaicin rinse
OTHERPlacebo
Mouth rinse with no capsaicin
Sponsors
Lund University
Malmö University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
One clinical examinator for all examinations (baseline examination, outcome assessments), randomization, allocation and drug management by another person,
Intervention model description
N-of-1 design. Three two-week treatment arms with a one-week wash-out period in between. After that, the patient will chose their preferred treatment and continue with that treatment for 6 months (i.e. this part is not randomized or controlled).
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary BMS according to International Classification of Orofacial Pain (ICOP) OR diagnosis of other oral mucosal pains according to ICOP
Exclusion criteria
* Fibromyalgia * IBS * Reflux * Recent (\<3 months) intraoral surgical procedure * Ongoing medication with Clonazepam or Capsaicin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Point measurement, will be assessed immediately before start of treatment | Overall oral mucosa pain intensity. Will be assessed using the subscale Characteristic pain intensity (three numerical rating scales 0 - 10 assessing current pain. intensity as well as worst and average pain intensity during the last two weeks) in the Graded Chronic Pain Scale |
| Patient satisfaction | Point measurement, will be assessed immediately before start of treatment | Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain-related disability | Point measurement, will be assessed immediately before start of treatment as well as one, two and three weeks after treatment start. | Pain-related disability from oral mucosal pains. Will be assessed using the subscale Pain-related Disability (three numerical rating scales 0 - 10 assessing impact on the oral pain on general, social and work-related activities during the last two weeks) in the Graded Chronic Pain Scale |
Contacts
Primary ContactPer Alstergren, PhD, Prof
Backup ContactThomas List, PhD, Prof
Outcome results
None listed