Effects of proprioceptive neuromuscular facilitation in addition to routine physical therapy on pain, range of motion and postural alignment in patients with temporomandibular joint disorders: A Randomized Controlled Trial
To explore effects of proprioceptive neuromuscular facilitation in addition to routine physical therapy on pain, range of motion and postural alignment in patients with temporomandibular joint disorders.
Design
Parallel, 58 Sample size, Randomized Controlled Trial, single blinded
Settings and conduct
Trial will be conducted in Physiotherapy department of Punjab Social Security Health Management Company Hospital. Assessor will be completely blind about outcomes.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 20-50 year individuals,
Having temporomandibular joint disorders with abnormal neck alignment,
Pre-diagnosed patients referred by dentist and orthotics.
Exclusion criteria:
Systemic or local pathology like infectious or vascular disease of orofacial region
Patient using another form of treatment for temporomandibular disorders
Patient using functional appliances
H/o frequent open dislocation
Cervical radiculopathies
Rheumatoid arthritis
Osteoarthritis of temporomandibular joint
peripheral nerve injury
Intervention groups
Group A (control) will follow routine physiotherapy (icing\ ultrasound\TENS and stretching\strengthening) and group B (intervention) will follow proprioceptive neuromuscular facilitation(PNF) program with routine physiotherapy. Both groups will follow 3 sessions per week for 4 weeks and home exercises for 2 weeks. Pain, Range of motion and Postural assessment will be conducted on 1st, 6th and 12th week.The PNF program will compose of a total of 8 therapeutic exercises. Contract relax, Combination of isotonic, Stabilizing reversals, and Rhythmic stabilization techniques will be used for elongation of upper cervical extensors, strengthening of infra-hyoid muscles, Increase stability and mobility of mandible in corrected posture of neck.
Main outcome variables
Pain , Range of motion, Impairment of body structure and body function test.
General information
Reason for update
Acronym
RCT
IRCT registration information
IRCT registration number:IRCT20210704051785N1
Registration date:2021-09-28, 1400/07/06
Registration timing:registered_while_recruiting
Last update:2021-09-28, 1400/07/06
Update count:1
Registration date
2021-09-28, 1400/07/06
Registrant information
Name
Sarwat Anees
Name of organization / entity
Sharif medical and dental college
Country
Pakistan
Phone
+92 42 35397101
Email address
sarwatasifmehmood@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-01, 1400/06/10
Expected recruitment end date
2021-09-30, 1400/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of proprioceptive neuromuscular facilitation in addition to routine physical therapy on pain, range of motion and postural alignment in patients with temporomandibular joint disorders: A Randomized Controlled Trial
Public title
Proprioceptive neuromuscular facilitation exercises with routine physical therapy for temporomandibular joint disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having temporomandibular joint disorders with postural neck alignment
Pre-diagnosed patients referred by dentist and orthotics
Exclusion criteria:
Systemic or local pathology like infectious or vascular disease of orofacial region
Patient using another form of treatment for temporomandibular disorders
Patient using functional appliances
History of frequent open dislocation
Rheumatoid arthritis
Cervical radiculopathies
Osteoarthritis of temporomandibular joint
Peripheral nerve injury
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed envelope method will be used for random allocation. 58 sealed envelopes (29 for Group A and 29 for Group B) will be prepared. 29 envelopes will contain letter A, 29 envelopes will contain letter B on a card. Patient will be asked to choose one envelope. Treatment will be given according to treatment group (Group A: control, Group B: experiment).
Blinding (investigator's opinion)
Single blinded
Blinding description
Senior physiotherapist will assess patient before and after treatment. Senior physiotherapist/assessor will be completely blinded about patient allocation group (control/intervention).
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of The University of Lahore
Street address
Sharif polyclinic, near doce bakers, railway road raiwind
City
Lahore
Postal code
55150
Approval date
2021-06-17, 1400/03/27
Ethics committee reference number
IRB-UOL-FAHS/890/2021
Health conditions studied
1
Description of health condition studied
Temporomandibular Joint Disorder due to Postural Alignment (Forward Head Posture)
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders
2
Description of health condition studied
Temporomandibular Joint Disorders due to Forward Head Posture
ICD-10 code
M26.60
ICD-10 code description
Temporomandibular joint disorder, unspecified
Primary outcomes
1
Description
Range of motion of temporomandibular joint(activity limitation test)
Timepoint
Range of motion will be measure before and after 6, 12 week of treatment
Method of measurement
Range of motion measure through vernier caliper
2
Description
Pain
Timepoint
Pain will be measure before and after 6, 12 week of treatment
Method of measurement
VAS scale will be used to measure pain
Secondary outcomes
1
Description
Impairment of body structure and body function test (forward head posture)
Timepoint
Different postural angles will be measure before and after 6, 12 week of treatment
Method of measurement
A picture will be taken from camera from 2 meter. lines will be drawn to picture to measure sagittal head, cervical line and shoulder angles for postural assessment.
Intervention groups
1
Description
Control group will follow routine physical therapy which include icing\ ultrasound\TENS \infrared and stretching\strengthening exercises for 4 weeks(3 session per week) and home exercises for 2 weeks. infrared\TENS\icing apply for 20 mins over temporomandibular joint and ultrasound for 4 min on 3 MHZ frequency. Modalities will b decided according to acute and chronic condition, in acute icing will be used, in chronic condition infrared will be used. TENS/ ultrasound will be used in all patients. Routine strengthening/stretching exercises will be used to strengthen jaw muscles. Exercise no:1 Place your fist below the jaw. Resist downward movement of your chin. Hold it for 10 seconds and relax for 5 seconds. Repeat 10 times; do it 3 times per day. Exercise no:2 Place your two fingers on the left side of the jaw. Resist its movement to the same side.Hold it for 10 seconds and relax for 5 seconds.Repeat 10 times; do it 3 times per day. Repeat on the opposite side.Exercise no:3 Bend your index finger and place the knuckle between your front teeth, hold it for 6 seconds.If your symptoms are not aggravated, increase your opening width to 2 fingers, hold it for 10 seconds. You can continue increasing your opening range and your time by 3 fingers, 20 seconds and 5 repetitions, do it 3 times per day.Exercise no:4 Sit or stand by a mirror.Place the tip of your tongue behind your top teeth. Gentely lower your jaw to open your mouth while keeping your tongue in contact with the roof of your mouth. Usethe mirror to make sure that you are opening your mouth evenly, and not moving your jaw from side to side. Close your mouth. Repeat 10 times; do it 3 times per day. Exercise will be progressed according to patient condition.
Category
Rehabilitation
2
Description
Group B follow routine physiotherapy (except strengthening\stretching exercises) with proprioceptive neuromuscular facilitation (PNF) program, which is compose of 12 sessions over 4 weeks, each session will continue 30 min and follow home exercise plan for 02 week. PNF program will be terminated after 4th week. The PNF program will compose of a total of 08 therapeutic exercises, including the home exercise. In consideration of the alignment of the cervical spine and the pain in the temperomandibular joint, the posture with a wider base of support will be modified to have a narrower one. All exercise programs will be designed based on the PNF basic principles, basic procedures, and philosophy of PNF. The patterns and techniques of PNF will be adapted to the hypothesis of activity limitation. The PNF program, which extends over 4 weeks, took the programs of each week will be adjusted by combining three to four exercise programs. As a result, three sessions will be conducted in each week, and each of these sessions last for 30 min.Contract relax, Combination of isotonic, Stabilizing reversals, and Rhythmic stabilization techniques will be used for elongation of upper cervical extensors, strengthening of infra-hyoid muscles, Increase stability and mobility of mandible in corrected posture of neck. Before the starting of the exercise program, the patient was given with an overall explanation and detailed instructions on deep-breathing. The exercise will be interrupted when the patient reported pain or fatigue to have a 2 to 3 min break. The break will not include in the total duration of exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Punjab social security health management company hospital, raiwind, lahore
Full name of responsible person
Sarwat Anees
Street address
8 km from manga road raiwind lahore
City
Lahore
Postal code
55150
Phone
+92 42 35397101
Email
sarwatasifmehmood@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr ashfaq ahmad
Street address
1- KM Defence road campus, lahore
City
lahore
Postal code
54590
Phone
+92 42 86586523
Email
info@uol.edu.pk
Web page address
https://uol.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Lahore
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Punjab Social Security Health Management Company Hospital
Full name of responsible person
Sarwat Anees
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Sharif Polyclinic, near Doce Bakers, Railway Road, Raiwind
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 303 4846498
Email
sarwatasifmehmood@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Punjab Social Security Health Management Company Hospital
Full name of responsible person
Sarwat Anees
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Sharif Polyclinic, near Doce Bakers, Railway Road Raiwind
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 303 4846498
Email
sarwatasifmehmood@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Punjab Social Security Health Management Company Hospital
Full name of responsible person
Sarwat Anees
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Sharif Polyclinic, near Doce Bakers, Railway Road, Raiwind
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 303 4846498
Email
sarwatasifmehmood@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available