Protocol summary
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Study aim
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To find out the effect of ischemic compression therapy and shock wave therapy for releasing trigger point on temporomandibular dysfunction.
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Design
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It will be single blinding randomize clinical trial in which 45 individuals will be recruited.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Pain will be measure by using visual analogue scale.
Functional ability will be measure by using temporomandibular dysfunction questionnaire before and after treatment
General information
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Reason for update
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To update the missing information
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Acronym
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Shock wave therapy (SWT) Ischemic compression therapy(ISC) Temporomandibular dysfunction(TMD)
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IRCT registration information
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IRCT registration number:
IRCT20240120060742N1
Registration date:
2024-02-15, 1402/11/26
Registration timing:
prospective
Last update:
2025-02-08, 1403/11/20
Update count:
1
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Registration date
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2024-02-15, 1402/11/26
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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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2024-03-18, 1402/12/28
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Expected recruitment end date
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2024-03-18, 1402/12/28
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Actual recruitment start date
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2024-06-18, 1403/03/29
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Actual recruitment end date
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2024-06-18, 1403/03/29
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Trial completion date
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2024-07-18, 1403/04/28
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Scientific title
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Analgesic effect of ischemic compression therapy and shock wave therapy for trigger point release on temporomandibular dysfunction.
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Public title
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Trigger point release on temporomandibular dysfunction by ischemic compression therapy and shock wave therapy.
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 60 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:
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
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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It is a single blind study, participants will be blinded as they will not known the treatment which they will receive.
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Placebo
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Not used
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Assignment
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Other
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Other design features
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sampling technique
Ethics committees
1
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Ethics committee
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Approval date
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2021-02-27, 1399/12/09
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Ethics committee reference number
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TUF/Addl Reg/A-14/119
Health conditions studied
1
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Description of health condition studied
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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.
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ICD-10 code
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K07.6
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ICD-10 code description
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Temporomandibular joint-pain-dysfunction syndrome
Primary outcomes
1
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Description
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Visual analogous scale.
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Timepoint
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At the time of enrollment, later after 3rd and last after the 6th session.
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Method of measurement
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1-10 Points on paper
2
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Description
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visual analogous scale
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Timepoint
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At the time of enrollment, later after 3rd and last after the 6th session.
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Method of measurement
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1-10 Points on paper
Secondary outcomes
1
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Description
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Temporomandibular dysfunction questionnaire before and after treatment.
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Timepoint
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At the time of enrollment, later after 3rd and last after the 6th session.
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
3
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Description
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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.*
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Category
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Treatment - Other
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 Faisalabad.
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Foreign
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Category of foreign source of funding
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Sponsor: country of origin
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Country of origin
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PK
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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For concealing participants identity
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Analgesic effect of ischemic compression therapy and shock wave therapy for trigger point release on temporomandibular dysfunction.
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When the data will become available and for how long
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Starting from April 2021
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To whom data/document is available
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This data is available for the people who are working in academic institutions.
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Under which criteria data/document could be used
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Data will be available to researchers with valid affiliation to any institute.
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From where data/document is obtainable
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noreenfatima12390@gmail.com
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What processes are involved for a request to access data/document
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Inquirer must provide cover letter starting their reason to obtain data and a brief outlook of their research.
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Comments
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