Protocol summary
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Study aim
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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.
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Design
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Parallel, 58 Sample size, Randomized Controlled Trial, single blinded
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Settings and conduct
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Trial will be conducted in Physiotherapy department of Punjab Social Security Health Management Company Hospital. Assessor will be completely blind about outcomes.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Pain , Range of motion, Impairment of body structure and body function test.
General information
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Reason for update
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routine physiotherapy also includes a range of motion and stretching exercises of the jaw.
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Acronym
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RCT
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IRCT registration information
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IRCT registration number:
IRCT20210704051785N1
Registration date:
2021-09-28, 1400/07/06
Registration timing:
registered_while_recruiting
Last update:
2022-06-16, 1401/03/26
Update count:
1
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Registration date
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2021-09-28, 1400/07/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-09-01, 1400/06/10
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Expected recruitment end date
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2021-09-30, 1400/07/08
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Proprioceptive neuromuscular facilitation exercises with routine physical therapy for temporomandibular joint disorders
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
58
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Senior physiotherapist will assess patient before and after treatment. Senior physiotherapist/assessor will be completely blinded about patient allocation group (control/intervention).
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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no
Ethics committees
1
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Ethics committee
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Approval date
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2021-06-17, 1400/03/27
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Ethics committee reference number
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IRB-UOL-FAHS/890/2021
Health conditions studied
1
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Description of health condition studied
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Temporomandibular Joint Disorder due to Postural Alignment (Forward Head Posture)
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ICD-10 code
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M26.6
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ICD-10 code description
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Temporomandibular joint disorders
2
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Description of health condition studied
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Temporomandibular Joint Disorders due to Forward Head Posture
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ICD-10 code
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M26.60
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ICD-10 code description
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Temporomandibular joint disorder, unspecified
Primary outcomes
1
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Description
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Range of motion of temporomandibular joint(activity limitation test)
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Timepoint
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Range of motion will be measure before and after 6, 12 week of treatment
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Method of measurement
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Range of motion measure through vernier caliper
2
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Description
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Pain
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Timepoint
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Pain will be measure before and after 6, 12 week of treatment
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Method of measurement
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VAS scale will be used to measure pain
Secondary outcomes
1
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Description
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Impairment of body structure and body function test (forward head posture)
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Timepoint
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Different postural angles will be measure before and after 6, 12 week of treatment
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Method of measurement
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photogrammatory method will be used. A picture will be taken from camera from 2 meter. lines will be drawn by posturescren app to measure sagittal head, cervical line and shoulder angles for postural assessment by the help of posture screen app.
Intervention groups
1
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Description
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Control group will follow routine physical therapy which include 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. Gently lower your jaw to open your mouth while keeping your tongue in contact with the roof of your mouth. Use the 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. range of motion of TMJ and mild stretch at the end of range in 10 rep 3 times a day.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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The University of Lahore
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Proportion provided by this source
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1
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable