Bell PalsyNCT05679752
Effects of Massage Therapy and Facial PNF in Early Bell's Palsy
A study testing Facial PNF technique and Massage therapy in people with Bell Palsy, run by Neuro Counsel Hospital, Pakistan at 1 site in Pakistan.
Trial summary
Effects of Massage therapy and Facial PNF in early Bell's palsy Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Facial PNF technique and Massage therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Sep 2022to 14 Dec 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both males and females with age between 20 to 50 years
- All patients diagnosed with Bell's palsy
- Non traumatic onset
- Acute onset 1 to 3 weeks
- Either right or left side
Who cannot join
- Subject who have other Neurological disorder
- Subjects who have impaired cognition
- Complete paralysis of face
- Open wound on face
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Al Nafees Medical Hospital, Islamabd
Islamabad, Federally Administered Tribal..., 44010
About this study
Effects of Massage therapy and Facial PNF in early Bell's palsy
Read the detailed description
It is an interventional study in which investigator will give massage therapy to one group of patients and facial PNF techniques to other group to evaluate the efficacy of these intervention on bell's palsy pateints
- Conditions
- Bell Palsy
- Being tested
- Facial PNF technique, Massage therapy
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial PNF techniqueOther
Also called Proprioceptive Neuromuscular Facilitation
Stimulation techniques used to facilitate the weak muscle groups
Massage therapyOther
Also called Passive massage
frictional massage to stimulate the weak muscle groups
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | massage therapy will be given to this group of participants Receives: Other: Massage therapy |
| experimental group | Experimental | Facial PNFtechnique will be given to this group of participants Receives: Other: Facial PNF technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sunnybrook facial grading scale
complete tool for assessing facial movement outcomes. Lower score (Zero) means complete paralysis and higher (100) means normal
Measured: assessment will be done after 6 weeks
Facial Clinimetric Evaluation Scale
to evaluate the impairment and disability associated with facial weakness. It is calculated ranging from 0 (worst) to 100 (best)
Measured: assessment will be done after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start21 Sep 2022
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell PalsyStudies 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trail
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuro Counsel Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- Al Nafees Medical Hospital, Islamabad, Reliance Hospital Rawalpindi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679752
- Sponsor's protocol ID
- 338
- Status last verified
- Mar 2023
- First submitted
- 15 Dec 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Still not decided about this.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Massage Therapy and Facial PNF in Early Bell's Palsy
- ClinicalTrials.gov ID
- NCT05679752
- Acronym / sponsor ID
- 338
- Conditions
- Bell Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Neuro Counsel Hospital, PakistanUniversity, hospital or other
- Collaborators
- Al Nafees Medical Hospital, Islamabad, Reliance Hospital Rawalpindi
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 11 Jan 2023 (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.
Effects of Massage therapy and Facial PNF in early Bell's palsy
Detailed description
It is an interventional study in which investigator will give massage therapy to one group of patients and facial PNF techniques to other group to evaluate the efficacy of these intervention on bell's palsy pateints
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized control trail
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Massage therapymassage therapy will be given to this group of participants |
| experimental group | Experimental | Other: Facial PNF techniqueFacial PNFtechnique will be given to this group of participants |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both males and females with age between 20 to 50 years
- All patients diagnosed with Bell's palsy
- Non traumatic onset
- Acute onset 1 to 3 weeks
- Either right or left side
Key exclusion criteria (4 listed)
- Subject who have other Neurological disorder
- Subjects who have impaired cognition
- Complete paralysis of face
- Open wound on face
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 |
|---|---|---|
| Facial PNF techniqueAlso: Proprioceptive Neuromuscular FacilitationStimulation techniques used to facilitate the weak muscle groups | Other | experimental group |
| Massage therapyAlso: Passive massagefrictional massage to stimulate the weak muscle groups | Other | control group |
Primary outcome
Sunnybrook facial grading scale
Time frame: assessment will be done after 6 weeks
complete tool for assessing facial movement outcomes. Lower score (Zero) means complete paralysis and higher (100) means normal
Facial Clinimetric Evaluation Scale
Time frame: assessment will be done after 6 weeks
to evaluate the impairment and disability associated with facial weakness. It is calculated ranging from 0 (worst) to 100 (best)
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 14 Mar 2023.
- Individual participant dataSharing planned: Undecided. Still not decided about this.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial PNF technique and Massage therapy in people with Bell Palsy, run by Neuro Counsel Hospital, Pakistan 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 5 inclusion and 4 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 14 Mar 2023. 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. 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?
Sunnybrook facial grading scale (time frame: assessment will be done after 6 weeks). The study lists 2 primary outcomes in all. 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 14 Mar 2023.