Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05897983 |
| Other study ID # |
782015 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 21, 2023 |
| Est. completion date |
May 31, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
72 patients who suffers from limited mouth opening and pain in the temporomandibular joint
will be selected from oncology department in Zagazig and Cairo university hospitals: patients
will be assigned randomly into three groups equal in number, 24 in each group: (group A) will
receive Rocabado exercises plus transcutaneous electrical nerve stimulation and traditional
exercises .(group B) will receive Rocabado exercises and traditional exercises.(groub C) will
receive transcutaneous electrical nerve stimulation and traditional exercises.
Description:
Patients at group A: patients will receive Rocabado exercises plus transcutaneous electrical
nerve stimulation and traditional exercises For 8 weeks : Rocabado exercises form of 2 parts
, 6×6×6 exercises and mobilization exercises part (1): 6×6×6 exercises are (1).The rest
position of the tongue , (2). Shoulder retraction exercises, (3). Stabilized head flexion ,(
4). The axial extension of the neck , (5).Control of TMJ rotation , (6).Rhythmic
stabilization technique .these 6 exercises are repeated 6 times a day for 20 minutes for each
repetition.
part (2): Joint mobilization (non-thrust manipulation) includes Distraction, Distraction
given with anterior glide, Distraction given with anterior and lateral glide right/left &
Lateral glide without distraction. . These mobilization exercises is done by the therapist 3
times a week for 20 min ,each mobilization is performed for 10-15 times and repeated for 5-6
times.
Transcutaneous electrical nerve stimulation device(TENS):
TENS is used, with a maximum frequency of 120 Hz and an intensity range of 0 to 99.5 mA and
the pulse width is between 50-200 microseconds.
TENS electrodes (diameter 35-52 mm) are placed bilaterally on mandibular elevator muscles, on
the superficial masseter muscle above the gonial angle, and bilaterally on the upper back
(Cacho et al.,2022).
The TENS will be applied for 20 min 2 sessions/week for 8 weeks.
Traditional exercises are passive , active Rom exercises and massage, these exercises are
performed for 30 minutes and repeated 2 times daily.
1. Passive ROM exercises are done by stacked tongue depressors and number of tongue
depressors are increased when improvement occur .
2. Active Rom exercises are mouth opening and closing ,side way movement and protrusion
repeated for 10-15 times with holding for 5 seconds for each position.
3. Massaging for cheeks muscles for 2minutes .
Patients at group B: patients will receive Rocabado exercises and traditional exercises For 8
weeks : Rocabado exercises form of 2 parts , 6×6×6 exercises and mobilization exercises part
(1): 6×6×6 exercises are (1).The rest position of the tongue ,(2). Shoulder retraction
exercises, (3) .Stabilized head flexion , (4).The axial extension of the neck , (5).Control
of TMJ rotation ,( 6).Rhythmic stabilization technique .these 6 exercises are repeated 6
times a day for 20 min for each repetition.
part(2): Joint mobilization (non-thrust manipulation) includes Distraction, Distraction given
with anterior glide, Distraction given with anterior and lateral glide right/left & Lateral
glide without distraction. . These mobilization exercises is done by the therapist 3 times a
week for 20 min ,each mobilization is performed for 10-15 times and repeated for 5-6 times.
Traditional exercises are passive , active Rom exercises and massage, these exercises are
performed for 30 minutes and repeated 2 times daily.
1. Passive ROM exercises are done by stacked tongue depressors and number of tongue
depressors are increased when improvement occur .
2. Active Rom exercises are mouth opening and closing ,side way movement and protrusion
repeated for 10-15 times with holding for 5 seconds for each position.
3. Massaging for cheeks for 2minutes .
patients at group C: patient will receive Transcutaneous electrical nerve stimulation
device(TENS) and traditional exercises: TENS is used, with a maximum frequency of 120 Hz and
an intensity range of 0 to 99.5 mA and the pulse width is between 50-200 microseconds.
TENS electrodes (diameter 35-52 mm) are placed bilaterally on mandibular elevator muscles, on
the superficial masseter muscle above the gonial angle, and bilaterally on the upper back
(Cacho et al.,2022).
The TENS will be applied for 20 min 2 sessions/week for 8 weeks.
Traditional exercises are passive , active Rom exercises and massage, these exercises are
performed for 30 minutes and repeated 2 times daily.
1. Passive ROM exercises are done by stacked tongue depressors and number of tongue
depressors are increased when improvement occur .
2. Active Rom exercises are mouth opening and closing ,side way movement and protrusion
repeated for 10-15 times with holding for 5 seconds for each position.
3. Massaging for cheeks for 2 minutes .
