Comparative evaluation of efficacy of Transcutaneous Electrical Nerve Stimulation (TENS), Transcutaneous Electrical Nerve Stimulation with Muscle relaxant, Transcutaneous Electrical Nerve Stimulation with Astaxanthin and Astaxanthin alone in the management of Myofascial Pain Dysfunction Syndrome (MPDS)
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- relief from muscle pain and tenderness
Study Overview
Brief Summary
Written informed consent will beobtained from patients included in the study. Detailed case history of eachpatient will be carried out with recording of all the relevant information.
All the included patients will bedivided into two groups by simple randomization technique after elimination thepreliminary cause.
STUDY DESIGN – A Prospective,Randomized, intervention Clinical Study.
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SOURCE OF DATA – Patient reporting indepartment of Oral & Medicine and Radiology of Dental Institute.
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STUDY POPULATION – Physically fithuman population with age between 18 to 60 years old.
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SAMPLE SIZE – Total number of 30 patientswere divided randomly in 4 groups as perthe inclusion criteria.
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SAMPLING TECHNIQUE – Simple RandomSampling
**GROUPI:**will be treated with TENS for 10 sessions, 3 sessions per week for 10 minuteswith one month follow-up.
GROUPII: Patientswill be treated for 10 sessions, 3 sessions per week for 10 minutes and mg Muscle relaxant will be given once a dayfor a month with one month follows up
GROUPIII: Patients will be treated for 10 sessions, 3 sessionsper week for 10 minutes and 8 mg Astaxanthin will be given once a day for amonth with one month follows up
GROUPIV: Patientswill be treated for 8 mg Astaxanthin once a day for a month with one monthfollows up
During each visit patients will beexamined for following clinical features
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Range of motion (ROM)- a.Interincisal distance- It will berecorded in mm by vernier calliper from mesio-incisal angle of upper centralincisor up to the mesio-incisal line angle of lower incisor on 1stand last day of treatment. b. Lateralexcursion movements 16.On 1st and on the last day oftreatment
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Observation of pain intensity atrest, on movement of jaw –It will be assessed by visual analog scale (VAS) on 1stand on the last day of treatment
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Palpation of muscle (grading based onscale for grades of tenderness): Grade of tenderness in various muscles at 1stand on the last day of treatment
4. SF-36 Quality of life Questionnaire
- Estimationof pre and post evaluation of oxidative stress using serum marker
Study Design
- Study Type
- Interventional
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •using Laskin’s criteria and DC/TMD Axis I and II criteria.
Exclusion Criteria
- •â€¢Patients Under management •Patients with congenital anomalies of TMJ •History of craniofacial trauma/fracture •Any other diseases causing TMJ pain •Congenital or degenerative changes of the spine •Patients with mental disorders/stress •Patients with pacemaker •Pregnant females •Patients with allergic to gel.
Outcomes
Primary Outcomes
relief from muscle pain and tenderness
Time Frame: from day one (Base line up to 2 months)
increase in mouth opening
Time Frame: from day one (Base line up to 2 months)
Secondary Outcomes
- to assess quality of life(baseline, 1 month and 2 months)