NCT05679752

Brief Summary

Effects of Massage therapy and Facial PNF in early Bell's palsy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 15, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

December 15, 2022

Last Update Submit

March 10, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Sunnybrook facial grading scale

    complete tool for assessing facial movement outcomes. Lower score (Zero) means complete paralysis and higher (100) means normal

    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)

    assessment will be done after 6 weeks

Study Arms (2)

control group

ACTIVE COMPARATOR

massage therapy will be given to this group of participants

Other: Massage therapy

experimental group

EXPERIMENTAL

Facial PNFtechnique will be given to this group of participants

Other: Facial PNF technique

Interventions

Stimulation techniques used to facilitate the weak muscle groups

Also known as: Proprioceptive Neuromuscular Facilitation
experimental group

frictional massage to stimulate the weak muscle groups

Also known as: Passive massage
control group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Subject who have other Neurological disorder
  • Subjects who have impaired cognition
  • Complete paralysis of face
  • Open wound on face

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Nafees Medical Hospital, Islamabd

Islamabad, Federally Administered Tribal..., 44010, Pakistan

Location

MeSH Terms

Conditions

Bell Palsy

Interventions

Muscle Stretching ExercisesMassage

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaTherapy, Soft TissueMusculoskeletal ManipulationsComplementary Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single blind RCT in which just participants do not know in which group they are being treated
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized control trail
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2022

First Posted

January 11, 2023

Study Start

September 21, 2022

Primary Completion

December 14, 2022

Study Completion

December 14, 2022

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations