Bell PalsyNCT03592797
Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis
A study testing Laser acupuncture therapy in people with Bell Palsy and Idiopathic Facial Paralyses, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Inadequate recovery from Bell's palsy is not uncommon and as consequence, physical and social impairment are exist in these patients. The medical options for chronic condition of Bell's palsy are insufficient. Low-level laser therapy has shown a favorable prognosis in the regeneration of peripheral nerves. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bell Palsy, Idiopathic Facial Paralyses
- What is being tested?
- Laser acupuncture therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 May 2018to 9 Dec 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed patients with Bell's palsy (ICD9- CM 351.0) with at least 3 months prior to screening.
- Age- above 20 years old
- Facial disability index (FDI) less than 80 on FDI physical subscale and less than 80 on the FDI social subscale.
Who cannot join
- Patients with any of the following are excluded: uncontrolled hypertension, diabetes mellitus requiring insulin injection, other neurological diseases, patients with multiple cranial nerve palsies, pregnancy or breastfeeding woman, will be excluded.
- Patients with other types of facial palsy or other known causes than Bell's palsy-Ramsay Hunt syndrome, cholesteatoma, Otitis media, traumatic facial palsy, iatrogenic facial palsy or parotid tumor will be excluded.
- Patients with recurrent facial palsy or patients who have pre-existing facial deformity, contracture, synkinesis, and spasm for whatever reason will be excluded.
- Patients with the following will be excluded:
- Surgery: a surgical history for facial palsy, such as facial nerve decompression, reconstruction of the facial nerve or muscle within 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis: A Randomized Sham Control, Double Blind Pilot Study
Inadequate recovery from Bell's palsy is not uncommon and as consequence, physical and social impairment are exist in these patients. The medical options for chronic condition of Bell's palsy are insufficient. Low-level laser therapy has shown a favorable prognosis in the regeneration of peripheral nerves. Moreover, laser acupuncture therapy (LAT) become widely used method to stimulate acupuncture points, but its efficacy as treatment method for Bell's palsy and during the chronic stage is unclear.
Read the detailed description
Background: Inadequate recovery from Bell's palsy is not uncommon and as consequence, physical and social impairment are exist in these patients. The medical options for chronic condition of Bell's palsy are insufficient. Low-level laser therapy has shown a favorable prognosis in the regeneration of peripheral nerves. Moreover, laser acupuncture therapy (LAT) become widely used method to stimulate acupuncture points, but its efficacy as treatment method for Bell's palsy and during the chronic stage is unclear.
Methods: This clinical trial settings are a randomized, placebo control, double blind pilot study including patients with the unsatisfactory recovery of Bell's palsy with the following two groups: LAT (N=16) and a sham LAT (N=16). The LAT will receive treatments for 6 weeks, compare to sham control group. The primary outcome measure will be change in the Facial Disability Index at week 6. Statistical analysis will also include changes in the House-Brackmann grading system, the Sunnybrook grading system and stiffness scale at 1, 3 and 6 weeks after randomization.
Expected outcome: The investigators hypothesis that LAT will have an effect on functional outcomes in patients with chronic facial paralysis. Moreover, changes in the S-B facial nerve grading system is also expected to have an improvement. Last, social subscale of FDI is expected to have an improvement.
- Conditions
- Bell Palsy, Idiopathic Facial Paralyses
- Being tested
- Laser acupuncture therapy, Sham laser acupuncture therapy
- Keywords
- Low-level laser therapy, Laser acupuncture, Sequelae of Bell's palsy, Randomized controlled trial
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupuncture therapyOther
Low level laser therapy to stimulate acupuncture points: Total 11 points will be used in the study. 7 points ST4, ST6, ST7, SI18, BL2, GB14, SJ17 located in the effected side of the face and will be stimulated ipsilateral. Two points ST36, LI4 located distally and will be stimulated bilateral.
Sham laser acupuncture therapyOther
Sham procedure of Low level laser therapy to stimulate acupuncture points is identical procedure as the intervention group. The same 11 points which mention above will be used, However, in the sham group the laser device will be deactivated and won't produce any laser beam irradiation.
| Study group | Role | What they receive |
|---|---|---|
| Laser acupuncture therapy group | Experimental | Each subject in the experimental group will receive laser acupuncture therapy using Handylaser Trion device (RJ Laser, Germany) to stimulate acupuncture points with laser beam irradiation. Receives: Other: Laser acupuncture therapy |
| Sham laser acupuncture therapy group | Sham comparator | Each subject in the sham control group will receive laser acupuncture therapy using Handylaser Trion device (RJ Laser, Germany). The laser device in the sham group will be deactivated and won't produce any laser beam irradiation on acupuncture points Receives: Other: Sham laser acupuncture therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the Facial Disability Index (FDI)
The primary outcome measurement in this study is the change of FDI after completing 6 weeks of laser acupuncture therapy. FDI scoring system consists of two domains; physical score and social score and each section consists five multiple choice question related to either physical or social issues occurred in the previous month. Subjects will fill up the questionnaire and the assessor will calculate the score according to the calculation in each section; physical section: total score (questions 1--5) minus N divided by N multiple 100 divided 4 equals to total score. social section; total score (questions 6--10) minus N divided by N multiple 100 divided by 5 equals to total score (N equals to number of questions answered). Higher values represent a better outcome. FDI evaluations will be performed on the first visit, the 9th visit and 18th visit and will be compared to the score at baseline.
Measured: Assessment will take place at baseline, end of third week and six week.
Secondary outcomes (3)
The change in the House-Brackmann (H-B) facial nerve grading system
The change of H-B facial nerve grading system will be compared after completing 6 weeks of laser acupuncture therapy. H-B facial nerve grading system includes 6 grades of facial paralysis; normal, mild, moderate, moderate severe, severe and complete paralysis. The study assessor asks the patient to move the facial muscles and then according to the result the assessor decides the grade of paralysis. The evaluations will be performed on the first visit, the 9th visit and 18th visit.
Measured: Assessment will take place at baseline, end of third week and six week.
The change in the Sunnybrook (S-B) facial nerve grading system
The change of S-B facial nerve grading system will be compared after completing 6 weeks of laser acupuncture therapy. S-B facial nerve grading system includes 3 subscales; resting symmetry (eye, cheek and mouth), symmetry of voluntary muscles and synkinesis. Besides the resting symmetry, in the two others subscales the assessor asks the patient to move the facial muscles and then give a score between 1 to 5 ( 1= unable to move 5= complete moment). Subscales are combined to compute a total score; symmetry of voluntary muscles subscale minus resting symmetry subscale minus synkinesis subscale equals to total score. Higher values represent a better outcome. The evaluations will be performed on the first visit, the 9th visit and 18th visit.
Measured: Assessment will take place at baseline, end of third week and six week.
The change in the stiffness scale
The change of the stiffness score will be compared to baseline. The stiffness scale will be hand in each session and the subject will choose one number from a five-point scale (1= no stiffness to 5= very stiff) according to the feeling in the face after receiving laser acupuncture therapy. Higher values represent a worse outcome.
Measured: Assessment will take place at baseline and end of six week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start5 May 2018
- Primary completion20 Jul 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bell PalsyStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- Model description
- Randomized, sham control, double blind pilot study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chen Lee, M.D PhD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592797
- Sponsor's protocol ID
- CMUH107-REC1-030
- Status last verified
- Dec 2020
- First submitted
- 11 Jun 2018
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ton G, Lee LW, Ng HP, Liao HY, Chen YH, Tu CH, Tseng CH, Ho WC, Lee YC. Efficacy of laser acupuncture for patients with chronic Bell's palsy: A study protocol for a randomized, double-blind, sham-controlled pilot trial. Medicine (Baltimore). 2019 Apr;98(15):e15120. doi: 10.1097/MD.0000000000015120.
PubMed 30985671
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis: A Randomized Sham Control, Double Blind Pilot Study
- ClinicalTrials.gov ID
- NCT03592797
- Acronym / sponsor ID
- CMUH107-REC1-030
- Conditions
- Bell Palsy, Idiopathic Facial Paralyses
- Keywords
- Low-level laser therapy, Laser acupuncture, Sequelae of Bell's palsy, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 5 May 2018 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 19 Jul 2018 (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.
Inadequate recovery from Bell's palsy is not uncommon and as consequence, physical and social impairment are exist in these patients. The medical options for chronic condition of Bell's palsy are insufficient. Low-level laser therapy has shown a favorable prognosis in the regeneration of peripheral nerves. Moreover, laser acupuncture therapy (LAT) become widely used method to stimulate acupuncture points, but its efficacy as treatment method for Bell's palsy and during the chronic stage is unclear.
Detailed description
Background: Inadequate recovery from Bell's palsy is not uncommon and as consequence, physical and social impairment are exist in these patients. The medical options for chronic condition of Bell's palsy are insufficient. Low-level laser therapy has shown a favorable prognosis in the regeneration of peripheral nerves. Moreover, laser acupuncture therapy (LAT) become widely used method to stimulate acupuncture points, but its efficacy as treatment method for Bell's palsy and during the chronic stage is unclear.
Methods: This clinical trial settings are a randomized, placebo control, double blind pilot study including patients with the unsatisfactory recovery of Bell's palsy with the following two groups: LAT (N=16) and a sham LAT (N=16). The LAT will receive treatments for 6 weeks, compare to sham control group. The primary outcome measure will be change in the Facial Disability Index at week 6. Statistical analysis will also include changes in the House-Brackmann grading system, the Sunnybrook grading system and stiffness scale at 1, 3 and 6 weeks after randomization.
Expected outcome: The investigators hypothesis that LAT will have an effect on functional outcomes in patients with chronic facial paralysis. Moreover, changes in the S-B facial nerve grading system is also expected to have an improvement. Last, social subscale of FDI is expected to have an improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, sham control, double blind pilot study
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture therapy group | Experimental | Other: Laser acupuncture therapyEach subject in the experimental group will receive laser acupuncture therapy using Handylaser Trion device (RJ Laser, Germany) to stimulate acupuncture points with laser beam irradiation. |
| Sham laser acupuncture therapy group | Sham comparator | Other: Sham laser acupuncture therapyEach subject in the sham control group will receive laser acupuncture therapy using Handylaser Trion device (RJ Laser, Germany). The laser device in the sham group will be deactivated and won't produce any laser beam irradiation on acupuncture points |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed patients with Bell's palsy (ICD9- CM 351.0) with at least 3 months prior to screening.
- Age- above 20 years old
- Facial disability index (FDI) less than 80 on FDI physical subscale and less than 80 on the FDI social subscale.
Key exclusion criteria (5 listed)
- Patients with any of the following are excluded: uncontrolled hypertension, diabetes mellitus requiring insulin injection, other neurological diseases, patients with multiple cranial nerve palsies, pregnancy or breastfeeding woman, will be excluded.
- Patients with other types of facial palsy or other known causes than Bell's palsy-Ramsay Hunt syndrome, cholesteatoma, Otitis media, traumatic facial palsy, iatrogenic facial palsy or parotid tumor will be excluded.
- Patients with recurrent facial palsy or patients who have pre-existing facial deformity, contracture, synkinesis, and spasm for whatever reason will be excluded.
- Patients with the following will be excluded:
- Surgery: a surgical history for facial palsy, such as facial nerve decompression, reconstruction of the facial nerve or muscle within 3 months.
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 |
|---|---|---|
| Laser acupuncture therapyLow level laser therapy to stimulate acupuncture points: Total 11 points will be used in the study. 7 points ST4, ST6, ST7, SI18, BL2, GB14, SJ17 located in the effected side of the face and will be stimulated ipsilateral. Two points ST36, LI4 located distally and will be stimulated bilateral. | Other | Laser acupuncture therapy group |
| Sham laser acupuncture therapySham procedure of Low level laser therapy to stimulate acupuncture points is identical procedure as the intervention group. The same 11 points which mention above will be used, However, in the sham group the laser device will be deactivated and won't produce any laser beam irradiation. | Other | Sham laser acupuncture therapy group |
Primary outcome
The change in the Facial Disability Index (FDI)
Time frame: Assessment will take place at baseline, end of third week and six week.
The primary outcome measurement in this study is the change of FDI after completing 6 weeks of laser acupuncture therapy. FDI scoring system consists of two domains; physical score and social score and each section consists five multiple choice question related to either physical or social issues occurred in the previous month. Subjects will fill up the questionnaire and the assessor will calculate the score according to the calculation in each section; physical section: total score (questions 1--5) minus N divided by N multiple 100 divided 4 equals to total score. social section; total score (questions 6--10) minus N divided by N multiple 100 divided by 5 equals to total score (N equals to number of questions answered). Higher values represent a better outcome. FDI evaluations will be performed on the first visit, the 9th visit and 18th visit and will be compared to the score at baseline.
3 secondary outcomes
The change in the House-Brackmann (H-B) facial nerve grading system
Time frame: Assessment will take place at baseline, end of third week and six week.
The change in the Sunnybrook (S-B) facial nerve grading system
Time frame: Assessment will take place at baseline, end of third week and six week.
The change in the stiffness scale
Time frame: Assessment will take place at baseline and end of six week.
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 22 Dec 2020.
- Derived from this study: PubMed 30985671Ton G, Lee LW, Ng HP, Liao HY, Chen YH, Tu CH, Tseng CH, Ho WC, Lee YC. Efficacy of laser acupuncture for patients with chronic Bell's palsy: A study protocol for a randomized, double-blind, sham-controlled pilot trial. Medicine (Baltimore). 2019 Apr;98(15):e15120. doi: 10.1097/MD.0000000000015120.
- Individual participant dataSharing planned: Undecided
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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.
Yu-Chen Lee, M.D PhD principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture therapy in people with Bell Palsy and Idiopathic Facial Paralyses, run by China Medical University Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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 22 Dec 2020. 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 Taiwan. 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 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?
The change in the Facial Disability Index (FDI) (time frame: Assessment will take place at baseline, end of third week and six week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03592797, which also lists 1 linked publication.
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 22 Dec 2020.