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General information
2021-01-18, 1399/10/29
2024-03-18, 1402/12/28
20212024-0103-18 00:00:00
2021-05-18, 1400/02/28
2024-03-18, 1402/12/28
20212024-0503-18 00:00:00
2021-06-18, 1400/03/28
2024-06-18, 1403/03/29
20212024-06-18 00:00:00
2021-10-18, 1400/07/26
2024-06-18, 1403/03/29
20212024-1006-18 00:00:00
2021-12-18, 1400/09/27
2024-07-18, 1403/04/28
20212024-1207-18 00:00:00
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Recruitment centers
#1
Name of recruitment center - English: ISLAMABAD DIAGNOSTIC CENTER FAISALABAD
Name of recruitment center - Persian:
Full name of responsible person - English: Noreen
Full name of responsible person - Persian:
Street address - English: Moize garden no 3 Satiyana Road Faisalabad
Street address - Persian:
City - English: Faisalabad
City - Persian:
Province: Punjab
Country: Pakistan
Postal code: 38000
Phone: +92 309 8827322
Fax:
Email: noreenfatima12390@gmail.com
Web page address:
Name of recruitment center - English: Islamabad diagnostic center Hospital Faisalabad/ physio fit
Name of recruitment center - Persian:
Full name of responsible person - English: Junaid Hassan
Full name of responsible person - Persian:
Street address - English: 563 B, Islamabad Diagnostic Center Faisalabad Satiana Road Faisalabad
Street address - Persian:
City - English: Faisalabad
City - Persian:
Province: Punjab
Country: Pakistan
Postal code: 092
Phone: +92 322 7500894
Fax:
Email: junaidhassan1192@gmail.com
Web page address: https://idc.net.pk/location/idc-faisalabad-satiana-road/
Name of recruitment center - English: ISLAMABAD DIAGNOSTIC CENTER FAISALABADIslamabad diagnostic center Hospital Faisalabad/ physio fit Name of recruitment center - Persian: Full name of responsible person - English: NoreenJunaid Hassan Full name of responsible person - Persian: Street address - English: Moize garden no 3 Satiyana563 B, Islamabad Diagnostic Center Faisalabad Satiana Road Faisalabad Street address - Persian: City - English: Faisalabad City - Persian: Province: Punjab Country: Pakistan Postal code: 38000092 Phone: +92 309 8827322322 7500894 Fax: Email: noreenfatima12390junaidhassan1192@gmail.com Web page address: https://idc.net.pk/location/idc-faisalabad-satiana-road/
Protocol summary
Study aim
To find out the effect of ischemic compression therapy and shock wave therapy for releasing trigger point on temporomandibular dysfunction.
Design
It will be single blinding randomize clinical trial in which 45 individuals will be recruited.
Settings and conduct
This study will be conducted on Islamabad diagnostic center Faisalabad. Participants will be blinded these individuals will not known in which group they will be allocated.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Functional disorder within masticatory muscle, Complaint of acute pain and presence of joint clicking.
Exclusion Criteria;
If individual have diabetes, Cardiovascular problem, sensory deficient , Skin lesion, fibromyalgia and tuberculosis.
Intervention groups
Interventional groups are three.
Group A will receive ischemic compression therapy, Group B will receive shock wave therapy,
And group C will receive the combination effect of ischemic compression therapy and shock wave therapy.
Main outcome variables
Pain will be measure by using visual analogue scale.
Functional ability will be measure by using temporomandibular dysfunction questionnaire before and after treatment
Analgesic effect of ischemic compression therapy and shock wave therapy for trigger point release on temporomandibular dysfunction.
Public title
Trigger point release on temporomandibular dysfunction by ischemic compression therapy and shock wave therapy.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gender both male and female.
Patient age ranges from 20 to 60 year.
Patients suffer from painful functional disorder within the masticatory muscles of myofascial characteristics.
Chief complaint of acute pain in the joint on at least one side (duration less than 6months).
Presence of joint clicking during opening that was eliminated on protrusive opening.
Exclusion criteria:
If individual have diabetes, cardiovascular problem, sensory deficient, skin lesion in thearea of trigger point, fibromyalgia and tuberculosis
Pregnant women, history of fascial trauma, fracture of facial bone and facial palsy
Presence of systemic disease and history of recent trauma
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
45
More than 1 sample in each individual
Number of samples in each individual:
15
Sample size was calculated through epi tool and according to that formula calculation there will be 45 sample size which will be further allocated into three groups by simple randomization technique. Group A will have 15 participants, Group B will have 15 participants, and Group C will have 15 participants.
Actual sample size reached:
45
More than 1 sample in each individual
Actual sample size in each individual:
15
randomization
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization through sealed envelope. Non-probability convenient sampling will use for the study. Groups allocation will be accomplished using simple randomization sampling technique. The participants will
be recruited into this study, allocation to groups will be done by chit and draw method.
Blinding (investigator's opinion)
Single blinded
Blinding description
It is a single blind study, participants will be blinded as they will not known the treatment which they will receive.
Placebo
Not used
Assignment
Other
Other design features
sampling technique
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics committee of University of Faisalabad
Street address
No.P-11,Zeenat Block, Muslim Town1: Faisalabad, Pakistan
City
Faisalabad
Postal code
14496-14535
Approval date
2021-02-27, 1399/12/09
Ethics committee reference number
TUF/Addl Reg/A-14/119
Health conditions studied
1
Description of health condition studied
Patients who will have experience orofascial pain, pain in the muscles of mastication due to trigger points on the temporomandibular joint will include in this study.
ICD-10 code
K07.6
ICD-10 code description
Temporomandibular joint-pain-dysfunction syndrome
Primary outcomes
1
Description
Visual analogous scale.
Timepoint
At the time of enrollment, later after 3rd and last after the 6th session.
Method of measurement
1-10 Points on paper
2
Description
visual analogous scale
Timepoint
At the time of enrollment, later after 3rd and last after the 6th session.
Method of measurement
1-10 Points on paper
Secondary outcomes
1
Description
Temporomandibular dysfunction questionnaire before and after treatment.
Timepoint
At the time of enrollment, later after 3rd and last after the 6th session.
Method of measurement
Questionnaire
Intervention groups
1
Description
Interventional Group 1 will receive ischemic compression therapy. *Baseline treatment was relaxation exercise. *Fist of all patients were relaxation on treatment bed in supine line position* There were 6 treatment session in one month. *There were three consecutive treatment sessions for three days. * There was relaxation period of one week. After relaxation of one week there were three consecutive treatment session for next three days. *The time of treatment in one session was five to eight minutes per patient. In this group of treatment therapist applied compression by thumb on active trigger points for 90 seconds. *Then relax for thirty seconds. *This type of compression was applied for three time in one session and continues for three consecutive days.
Category
Treatment - Other
2
Description
Intervention group B: will receive shock wave therapy *Baseline treatment was relaxation exercises. *Patients were relaxed on the treatment bed and treated in supine line position. *Patient lying on supine line position with slightly open mouth that will reflex the jaw muscles. *After localizing and palpating the pain region shock wave was applied with energy flux density of 1500 with shock wave frequency of 2000 strokes per therapy session. *About 2000 shock wave delivered per session on the active trigger points of masseter muscles. *There was 3 session of treatment in one week. *After that there was relaxation period of one week. *After relaxation period of one week Shock wave was applied for consecutive three days. *There were 3 session of treatment in one week. There were two weeks of treatment session.
Category
Treatment - Other
3
Description
Intervention group C: Interventional Group 3 will receive the combination effect of ischemic compression therapy and shock wave therapy. *Baseline treatment was relaxation exercise. *Patients were in relaxation in supine line. *Patients received 6 session in one month, 3 days consecutive treatment after one week of relaxation again 3 days consecutive treatment.*Patients received ischemic compression therapy first. *compression of 60 second with thumb on trigger point then relaxation of 30 second.*Time of treatment was 5 to 8 minutes.*After localizing and palpating the pain region shock wave was applied with energy flux density of 1500 with shock wave frequency of 2000 strokes per therapy session. *About 2000 shock wave delivered per session on the active trigger points of masseter muscles. There were total 6 treatment sessions with one week relaxation period. There were two weeks of treatment session.*
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamabad diagnostic center Hospital Faisalabad/ physio fit
Full name of responsible person
Junaid Hassan
Street address
563 B, Islamabad Diagnostic Center Faisalabad Satiana Road Faisalabad