Bell PalsyNCT06459830
Mime Therapy With and Without Neural Mobilization in Bell's Palsy.
A study testing Mime Therapy with Neural Mobilization in people with Bell Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the Effects of Mime Therapy with and without Neural Mobilization on Facial symmetry, Synkinesis and Functional abilities in Patients with Bell's Palsy. It has been proven that Mime therapy is effective on activating muscles through articulation exercises, facial expression exercises, breathing exercises… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Mime Therapy with Neural Mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Mar 2024to 15 Dec 2024
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Idiopathic bell's palsy. Age between 20 to 40 years. Both genders Sub-acute Bell's palsy lasting 3-6 months. Unilateral loss of facial weakness Intact taste sensation. House Brackman grade 4 and 5 (moderate to severe Bell's palsy)
Who cannot join
- Facial palsy recurrence. Patients with Diabetes, Hypertension, and any Auto-immune disorder. Chronic bell's palsy patients Patients with upper motor neuron lesions. Other cranial nerves problem. Pregnancy. Dental metal prosthesis. Facial surgery Skin allergy on face. Patients with Ear infection. Patients with Ear implants. Any neuro-degenerative disorder. Patients with Herpes zoster, Otitis media and Ramsay Hunt syndrome
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
DHQ, Kasur (Baba Bulleh Shah Hospital, District Kasur).
Kasur, Punjab Province
Heena Habib, 03334387127
About this study
Official title: Effects of Mime Therapy With and Without Neural Mobilization on Facial Symmetry, Synkinesis and Functional Abilities in Patients With Bell's Palsy.
To determine the Effects of Mime Therapy with and without Neural Mobilization on Facial symmetry, Synkinesis and Functional abilities in Patients with Bell's Palsy.
It has been proven that Mime therapy is effective on activating muscles through articulation exercises, facial expression exercises, breathing exercises and facial massages which can alleviate synkinesis, enhance facial symmetry and promote facial functional abilities. On the other hand, facial neural mobilization has recently reported as a safe and effective adjunctive therapy for patients with Bell's palsy due to the facilitation of nerve gliding in the canal impacts by reducing nerve adherence dispersion of noxious inflammatory agents and increasing neural blood supply. So, by incorporating the Neural mobilization with Mime therapy, therapist may enhance overall facial symmetry, reduce the strain on the facial muscles and alleviate synkinesis. So, it may prove to be an upgraded treatment option for clinicians.
Read the detailed description
A randomized controlled trail conducted in 2023, to evaluate the effect of facial neural mobilization over conventional therapy in improving facial symmetry in patients with acute Bell's palsy. The intervention included 10 days of drug therapy including 3 weeks of conventional therapy to the experimental and the control group. However, the experimental group received additional nerve mobilization technique aimed at mobilizing the facial nerve at the origin of external auditory meatus. Facial neural mobilization is likely to be an effective adjunctive intervention in addition to conventional therapy in improving facial symmetry in acute Bell's palsy.
Randomized clinical trial in 2021 aims to compare the effectiveness of mime therapy and neuromuscular re-education in improving facial symmetry and function in patients with acute Bell's palsy. Both mime therapy and neuromuscular re-education showed highly significant improvements within each group for both outcomes; they showed no difference between each group for the Sunnybrook Facial Grading System (P=0.212) and Facial Clinimetric Evaluation Scale (P=0.97). Both techniques are equally effective in the recovery of facial symmetry and function in acute Bell's palsy.
Another Author conducted a comparative interventional study in 2020 to compare the effects of Electromyography Biofeedback (EMG BFB) and Mime Therapy on electrophysiological parameters in subjects with Bell's palsy. A group of 31 subjects were selected for the study. Conventional physiotherapy with an EMG BFB and Mime therapy has an equal positive effect on electrophysiological parameters in subjects with Bell's palsy.
Many existing studies highlight the impact of Mime therapy on bell's palsy and related outcomes such as facial symmetry, synkinesis and functional abilities. Also, neural mobilization is reported as a safe and effective adjunctive therapy for patients with Bell's palsy. However, up to the researcher's knowledge, there is no research specifically on combined effects of Mime therapy and neural mobilization in patients with bell's palsy. So, this study aims to bridge this gap by investigating these effects. Moreover, it may help the clinicians to have an upgraded approach to treat these patients.
- Conditions
- Bell Palsy
- Being tested
- Mime Therapy with Neural Mobilization, Mime Therapy with Placebo Mobilization
- Keywords
- Bell's palsy, Facial Asymmetry, Facial Paralysis, Mime therapy, Mobilization
- Medical subject headings
- Bell Palsy, Facial Asymmetry, Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mime Therapy with Neural MobilizationOther
Experimental group will receive mime therapy and neural mobilization session with small resting intervals.
Self- facial massages for 10 minutes. Breathing and relaxation exercises for 5 mins. Exercises to enhance coordination between both sides of the face and to reduce synkinesis.
Exercises to assist with eye and lip closure for 5 mins. Articulation Exercises for 5 mins. Facial expression exercises for 10 mins.
Facial Neural Mobilization:
Facial mobilization technique will apply when the patient in supine position with head on the table in neural rotation.
The circular movement and horizontal traction will be applied 25 times in three sets with a 5-second rest period in between a single manipulation and a 30- second rest period in between the sets.
All the participates in the experimental group will receive 15 treatment sessions. Each session will held for 60 minutes per day, 5 days per week, for total duration of 3 weeks.
Mime Therapy with Placebo MobilizationOther
Control group will receive mime therapy and placebo nerve mobilization session with small resting intervals.
Self- facial massages for 10 minutes. Breathing and relaxation exercises for 5 mins. Exercises to enhance coordination between both sides of the face and to reduce synkinesis.
Exercises to assist with eye and lip closure for 5 mins. Articulation Exercises for 5 mins. Facial expression exercises for 10 mins.
Placebo Nerve Mobilization Technique:
The placebo nerve mobilization followed all the procedures of real nerve mobilization without applying horizontal and circular auricular traction. The purpose of this placebo nerve mobilization is not to deprived the control group from therapy and equalize the time duration of treatment protocol.
All the participates in the control group will receive 15 treatment sessions. Each session will held for 60 minutes per day, 5 days per week, for total duration of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mime Therapy with Neural Mobilization | Experimental | This group will receive mime therapy and neural mobilization session with resting intervals.
1. Self- facial massages for 10 minutes.
2. Breathing and relaxation exercises .
3. Exercises to enhance coordination between both sides of the face and to reduce synkinesis.
4. Exercises to assist with eye and lip closure.
5. Articulation Exercises.
6. Facial expression exercises
Facial Nerve Mobilization The circular movement and horizontal traction will be applied 25 times in three sets with a 5-second rest period in between a single manipulation and a 30- second rest period in between the sets.
All the participates in the experimental group will receive 15 treatment sessions. Each session will held for 60 minutes per day, 5 days per week, for total duration of 3 weeks. Receives: Other: Mime Therapy with Neural Mobilization |
| Mime Therapy with placebo Mobilization | Placebo comparator | Control group will receive mime therapy session with short resting intervals.
1. Self- facial massages for 10 minutes.
2. Breathing and relaxation exercises.
3. Exercises to enhance coordination between both sides of the face and to reduce synkinesis.
4. Exercises to assist with eye and lip closure.
5. Articulation Exercises.
6. Facial expression exercises.
Placebo Neural Mobilization Technique:
Placebo Mobilization followed all the procedures of real facial mobilization without applying horizontal and circular auricular traction. The purpose of this placebo facial nerve mobilization is not to deprived the control group from therapy.
All the participates in the control group will receive 15 treatment sessions. Each session will held for 60 minutes per day, 5 days per week, for total duration of 3 weeks. Receives: Other: Mime Therapy with Placebo Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sunny brook facial grading system
Facial symmetry was measured using the 13-item SFGS. The system includes three components: resting symmetry, the symmetry of voluntary movements, and synkinesis.
A composite facial symmetry score is calculated as [4 × symmetry of voluntary movement - 5 × resting asymmetry + 1 × synkinesis] with 100 representing normal facial symmetry.
The SFGS is as reliable when applied by novice users as by expert users. Researchers are using this method more frequently because it has been demonstrated to be repeatable, to have minimal inter-observer and intra-observer variability, and to be responsive to changes over time and as a consequence to treatments. The SFGS has high reliability and repeatability which is good to excellent ranging from 0.766 to 0.860.
Measured: 3rd week
Facial disability index
The FDI helps to measure the difficulties of the face in activities of daily living such as eating, drinking, and communicating. It represents the relationship between impairments, disability, and psychosocial status and also focuses on the disability of individuals with disorders of the facial motor system.
The reliability and internal consistency of the FDI (Cronbach's alpha coefficient) was 0.83 for the complete scale. Intra-class correlation was 0.79 (95% CI: 0.71-0.85) and 0.85 (95% CI: 0.78-0.89) for the physical and social well-being subscale
Measured: 3rd week
Kinovea Movement Analysis software
An objective analysis of the human movement can help both clinical assessment and sports performance. Kinovea is a free 2D motion analysis software that can be used to measure kinematic parameters. The Kinovea software is a valid and reliable tool that can measure accurately at distances up to 5 m from the object and at an angle range of 90°-45°. Nevertheless, for optimum results an angle of 90° is suggested and trustworthy instrument because of strong intra rater reliability(0.98-0.99) and inter rater reliability (0.95-0.98).
During recording, patients were asked to perform three movements as follows: first, raise the eyebrows (frontalis); second, smile with pursed lips (zygomatic); and third, pout the lips (orbicularis oris). The symmetry ratio was calculated while comparing each side of face
Measured: 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start25 Mar 2024
- Primary completion25 Nov 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Riphah International UniversityThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saifa Zia, Principal investigator, Riphah International University (Lahore)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459830
- Sponsor's protocol ID
- REC/RCR & AHS/23/0272
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cardoso JR, Teixeira EC, Moreira MD, Favero FM, Fontes SV, Bulle de Oliveira AS. Effects of exercises on Bell's palsy: systematic review of randomized controlled trials. Otol Neurotol. 2008 Jun;29(4):557-60. doi: 10.1097/MAO.0b013e31816c7bf1.
PubMed 18520590Paolucci T, Cardarola A, Colonnelli P, Ferracuti G, Gonnella R, Murgia M, Santilli V, Paoloni M, Bernetti A, Agostini F, Mangone M. Give me a kiss! An integrative rehabilitative training program with motor imagery and mirror therapy for recovery of facial palsy. Eur J Phys Rehabil Med. 2020 Feb;56(1):58-67. doi: 10.23736/S1973-9087.19.05757-5. Epub 2019 Mar 27.
PubMed 30916916
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mime Therapy With and Without Neural Mobilization on Facial Symmetry, Synkinesis and Functional Abilities in Patients With Bell's Palsy.
- ClinicalTrials.gov ID
- NCT06459830
- Acronym / sponsor ID
- REC/RCR & AHS/23/0272
- Conditions
- Bell Palsy
- Keywords
- Bell's palsy, Facial Asymmetry, Facial Paralysis, Mime therapy, Mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 25 Nov 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 14 Jun 2024 (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.
To determine the Effects of Mime Therapy with and without Neural Mobilization on Facial symmetry, Synkinesis and Functional abilities in Patients with Bell's Palsy.
It has been proven that Mime therapy is effective on activating muscles through articulation exercises, facial expression exercises, breathing exercises and facial massages which can alleviate synkinesis, enhance facial symmetry and promote facial functional abilities. On the other hand, facial neural mobilization has recently reported as a safe and effective adjunctive therapy for patients with Bell's palsy due to the facilitation of nerve gliding in the canal impacts by reducing nerve adherence dispersion of noxious inflammatory agents and increasing neural blood supply. So, by incorporating the Neural mobilization with Mime therapy, therapist may enhance overall facial symmetry, reduce the strain on the facial muscles and alleviate synkinesis. So, it may prove to be an upgraded treatment option for clinicians.
Detailed description
A randomized controlled trail conducted in 2023, to evaluate the effect of facial neural mobilization over conventional therapy in improving facial symmetry in patients with acute Bell's palsy. The intervention included 10 days of drug therapy including 3 weeks of conventional therapy to the experimental and the control group. However, the experimental group received additional nerve mobilization technique aimed at mobilizing the facial nerve at the origin of external auditory meatus. Facial neural mobilization is likely to be an effective adjunctive intervention in addition to conventional therapy in improving facial symmetry in acute Bell's palsy.
Randomized clinical trial in 2021 aims to compare the effectiveness of mime therapy and neuromuscular re-education in improving facial symmetry and function in patients with acute Bell's palsy. Both mime therapy and neuromuscular re-education showed highly significant improvements within each group for both outcomes; they showed no difference between each group for the Sunnybrook Facial Grading System (P=0.212) and Facial Clinimetric Evaluation Scale (P=0.97). Both techniques are equally effective in the recovery of facial symmetry and function in acute Bell's palsy.
Another Author conducted a comparative interventional study in 2020 to compare the effects of Electromyography Biofeedback (EMG BFB) and Mime Therapy on electrophysiological parameters in subjects with Bell's palsy. A group of 31 subjects were selected for the study. Conventional physiotherapy with an EMG BFB and Mime therapy has an equal positive effect on electrophysiological parameters in subjects with Bell's palsy.
Many existing studies highlight the impact of Mime therapy on bell's palsy and related outcomes such as facial symmetry, synkinesis and functional abilities. Also, neural mobilization is reported as a safe and effective adjunctive therapy for patients with Bell's palsy. However, up to the researcher's knowledge, there is no research specifically on combined effects of Mime therapy and neural mobilization in patients with bell's palsy. So, this study aims to bridge this gap by investigating these effects. Moreover, it may help the clinicians to have an upgraded approach to treat these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mime Therapy with Neural Mobilization | Experimental | Other: Mime Therapy with Neural MobilizationThis group will receive mime therapy and neural mobilization session with resting intervals. 1. Self- facial massages for 10 minutes. 2. Breathing and relaxation exercises . 3. Exercises to enhance coordination between both sides of the face and to reduce synkinesis. 4. Exercises to assist with eye and lip closure. 5. Articulation Exercises. 6. Facial expression exercises Facial Nerve Mobilization The circular movement and horizontal traction will be applied 25 times in three sets with a 5-second rest period in between a single manipulation and a 30- second rest period in between the sets. All the participates in the experimental group will receive 15 treatment sessions. Each session will held for 60 minutes per day, 5 days per week, for total duration of 3 weeks. |
| Mime Therapy with placebo Mobilization | Placebo comparator | Other: Mime Therapy with Placebo MobilizationControl group will receive mime therapy session with short resting intervals. 1. Self- facial massages for 10 minutes. 2. Breathing and relaxation exercises. 3. Exercises to enhance coordination between both sides of the face and to reduce synkinesis. 4. Exercises to assist with eye and lip closure. 5. Articulation Exercises. 6. Facial expression exercises. Placebo Neural Mobilization Technique: Placebo Mobilization followed all the procedures of real facial mobilization without applying horizontal and circular auricular traction. The purpose of this placebo facial nerve mobilization is not to deprived the control group from therapy. All the participates in the control group will receive 15 treatment sessions. Each session will held for 60 minutes per day, 5 days per week, for total duration of 3 weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Idiopathic bell's palsy. Age between 20 to 40 years. Both genders Sub-acute Bell's palsy lasting 3-6 months. Unilateral loss of facial weakness Intact taste sensation. House Brackman grade 4 and 5 (moderate to severe Bell's palsy)
Key exclusion criteria (1 listed)
- Facial palsy recurrence. Patients with Diabetes, Hypertension, and any Auto-immune disorder. Chronic bell's palsy patients Patients with upper motor neuron lesions. Other cranial nerves problem. Pregnancy. Dental metal prosthesis. Facial surgery Skin allergy on face. Patients with Ear infection. Patients with Ear implants. Any neuro-degenerative disorder. Patients with Herpes zoster, Otitis media and Ramsay Hunt syndrome
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 |
|---|---|---|
| Mime Therapy with Neural MobilizationExperimental group will receive mime therapy and neural mobilization session with small resting intervals. Self- facial massages for 10 minutes. Breathing and relaxation exercises for 5 mins. Exercises to enhance coordination between both sides of the face and to reduce synkinesis. Exercises to assist with eye and lip closure for 5 mins. Articulation Exercises for 5 mins. Facial expression exercises for 10 mins. Facial Neural Mobilization: Facial mobilization technique will apply when the patient in supine position with head on the table in neural rotation. The circular movement and horizontal traction will be applied 25 times in three sets with a 5-second rest period in between a single manipulation and a 30- second rest period in between the sets. All the participates in the experimental group will receive 15 treatment sessions. Each session will held for 60 minutes per day, 5 days per week, for total duration of 3 weeks. | Other | Mime Therapy with Neural Mobilization |
| Mime Therapy with Placebo MobilizationControl group will receive mime therapy and placebo nerve mobilization session with small resting intervals. Self- facial massages for 10 minutes. Breathing and relaxation exercises for 5 mins. Exercises to enhance coordination between both sides of the face and to reduce synkinesis. Exercises to assist with eye and lip closure for 5 mins. Articulation Exercises for 5 mins. Facial expression exercises for 10 mins. Placebo Nerve Mobilization Technique: The placebo nerve mobilization followed all the procedures of real nerve mobilization without applying horizontal and circular auricular traction. The purpose of this placebo nerve mobilization is not to deprived the control group from therapy and equalize the time duration of treatment protocol. All the participates in the control group will receive 15 treatment sessions. Each session will held for 60 minutes per day, 5 days per week, for total duration of 3 weeks. | Other | Mime Therapy with placebo Mobilization |
Primary outcome
Sunny brook facial grading system
Time frame: 3rd week
Facial symmetry was measured using the 13-item SFGS. The system includes three components: resting symmetry, the symmetry of voluntary movements, and synkinesis. A composite facial symmetry score is calculated as [4 × symmetry of voluntary movement - 5 × resting asymmetry + 1 × synkinesis] with 100 representing normal facial symmetry. The SFGS is as reliable when applied by novice users as by expert users. Researchers are using this method more frequently because it has been demonstrated to be repeatable, to have minimal inter-observer and intra-observer variability, and to be responsive to changes over time and as a consequence to treatments. The SFGS has high reliability and repeatability which is good to excellent ranging from 0.766 to 0.860.
Facial disability index
Time frame: 3rd week
The FDI helps to measure the difficulties of the face in activities of daily living such as eating, drinking, and communicating. It represents the relationship between impairments, disability, and psychosocial status and also focuses on the disability of individuals with disorders of the facial motor system. The reliability and internal consistency of the FDI (Cronbach's alpha coefficient) was 0.83 for the complete scale. Intra-class correlation was 0.79 (95% CI: 0.71-0.85) and 0.85 (95% CI: 0.78-0.89) for the physical and social well-being subscale
Kinovea Movement Analysis software
Time frame: 3rd week
An objective analysis of the human movement can help both clinical assessment and sports performance. Kinovea is a free 2D motion analysis software that can be used to measure kinematic parameters. The Kinovea software is a valid and reliable tool that can measure accurately at distances up to 5 m from the object and at an angle range of 90°-45°. Nevertheless, for optimum results an angle of 90° is suggested and trustworthy instrument because of strong intra rater reliability(0.98-0.99) and inter rater reliability (0.95-0.98). During recording, patients were asked to perform three movements as follows: first, raise the eyebrows (frontalis); second, smile with pursed lips (zygomatic); and third, pout the lips (orbicularis oris). The symmetry ratio was calculated while comparing each side of face
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 18520590Cardoso JR, Teixeira EC, Moreira MD, Favero FM, Fontes SV, Bulle de Oliveira AS. Effects of exercises on Bell's palsy: systematic review of randomized controlled trials. Otol Neurotol. 2008 Jun;29(4):557-60. doi: 10.1097/MAO.0b013e31816c7bf1.
- Background: PubMed 30916916Paolucci T, Cardarola A, Colonnelli P, Ferracuti G, Gonnella R, Murgia M, Santilli V, Paoloni M, Bernetti A, Agostini F, Mangone M. Give me a kiss! An integrative rehabilitative training program with motor imagery and mirror therapy for recovery of facial palsy. Eur J Phys Rehabil Med. 2020 Feb;56(1):58-67. doi: 10.23736/S1973-9087.19.05757-5. Epub 2019 Mar 27.
- Individual participant dataSharing planned: No
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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.
Saifa Zia principal investigator
Riphah International University (Lahore)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mime Therapy with Neural Mobilization in people with Bell Palsy, run by Riphah International University at 1 site in Pakistan.
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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wajiha shahid (03214885079, wajishahid89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sunny brook facial grading system (time frame: 3rd week). The study lists 3 primary outcomes in all. 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 NCT06459830, which also lists 2 linked publications.
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 14 Jun 2024.