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IRCT201201018585N1 IRCT 2012-02-01 Vice chancellor for research, Shiraz University of Medical Sciences The effect of laser therapy on the orofacial pain The clinical trial to compare the effect of laser therapy associated with drug therapy on relieving the most common orofacial pains in patients who have trigeminel neuralgia, atypical facial pain and myofacial pain dysfunction syndrome 2010-01-20 anticipated 60 Complete https://irct.ir/trial/9071 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Condition 1: Trigeminal Neuralgia. Condition 2: Myofacial Pain Dysfunction Syndroms. Condition 3: Atypical Facial Pain. Intervention 1: Intervention group: 10 section of Low level laser therapy (LLLT) + standard drug therapy of their pain The type of laser is Ga-AS (Device model: DLT 101) with pulse mode-mod II of exposure. The time of exposure is 5 min with frequency of 3000 HZ, 5 watt potency.The wave length of device is 980 -850 nm. According to these properties the total dose is 6.3 J/cm2. The Laser is applied on the trigger point if it exists, if not the operator will choose some trigger points on the pathway of pain. Intervention 2: Control group: Sham laser + Standard drug therapy of their pain Diagnosis of orofacial pain: Trigeminal neuralgia (TN) is the most common of the cranial neuralgias and chiefly affects individuals older than 50 years of age. It has characteristic clinical feature which include episode of intense shooting, stabbing pain that lasts for a few seconds and then completely disappear. The pain has electric like quality and is unilateral except in few cases.TN is precipitated by nonnoxious stimulation like a light touch on a trigger zone. Presence of trigger point is pathognomic for TN. The most common treatment recommended for TN is as followed: Carabamazepin , Gabapentin, Lamotrigin, Phenitoein, Oxcarbazepin, Valproic acid , Topiramate Other effective drugs other than anticonvulsants are Clonazepam , Baclofen, Diazepam, Pimozide IHS system, use the term facial pain not fulfilling other criteria to describe patients with atypical facial pain. This pain is a chronic pain syndrome which does not fall into other diagnostic categories. The major manifestation of AFP is a constant dull, aching pain without an apparent cause. It’s not paroxysmal and doesn’t precipitate by activity and doesn’t follow any anatomic pattern. Analgesics have no effect on AFP but tricyclic antidepressants can reduce the pain. It seems that psycho therapy has an important role in AFP treatment. Myofacial pain dysfunction syndrome (MPDS) is a muscular pain due to increased load and muscular hyperactivity. MPDS manifests as a dull pain with a tender trigger point in muscles, tendon and their fascias which are tender on palpation. The referral pain and autonomic symptoms can be detected on palpation of the trigger zone. The muscle relaxants (methocarbamol) and NSAIDs can relieve the symptoms.
public Dr. Fatemeh Lavaee
Ghasrdasht Street, Shiraz, Shiraz Dental School, Oral Medicine Department
Shiraz Iran (Islamic Republic of) +98 71 1631 9309 lavaeef@sums.ac.ir; fatemeh.lavaee@yahoo.com Shiraz Dental School scientific Dr. Fatemeh Lavaee
Ghasrdasht Street, Shiraz, Shiraz Dental School, Oral Medicine Department
Shiraz Iran (Islamic Republic of) +98 71 1631 9309 lavaeef@sums.ac.ir; fatemeh.lavaee@yahoo.com Shiraz Dental School Iran (Islamic Republic of) Inclusion criteria: Having the criteria of each of the pains including Trigeminel Neuralgia, Atypical Facial Pain and Myofacial Pain Dysfunction Syndrome؛ The patients who have not a good response to routine drug therapy؛ Exclusion criteria: the patients who have a good response to previous drug therapy؛ The pregnant women no limit no limit Both G50.0 M62.4 G50.1 Diseases of the nervous system,disorders of 5th cranial nerve Diseases of the musculoskeletal system and connective tissue, Other disorders of muscle Nerve, nerve root and plexus disorders, disorders of 5th cranial nerve Treatment - Other Treatment - Drugs Intervention group: 10 section of Low level laser therapy (LLLT) + standard drug therapy of their pain The type of laser is Ga-AS (Device model: DLT 101) with pulse mode-mod II of exposure. The time of exposure is 5 min with frequency of 3000 HZ, 5 watt potency.The wave length of device is 980 -850 nm. According to these properties the total dose is 6.3 J/cm2. The Laser is applied on the trigger point if it exists, if not the operator will choose some trigger points on the pathway of pain. Control group: Sham laser + Standard drug therapy of their pain Diagnosis of orofacial pain: Trigeminal neuralgia (TN) is the most common of the cranial neuralgias and chiefly affects individuals older than 50 years of age. It has characteristic clinical feature which include episode of intense shooting, stabbing pain that lasts for a few seconds and then completely disappear. The pain has electric like quality and is unilateral except in few cases.TN is precipitated by nonnoxious stimulation like a light touch on a trigger zone. Presence of trigger point is pathognomic for TN. The most common treatment recommended for TN is as followed: Carabamazepin , Gabapentin, Lamotrigin, Phenitoein, Oxcarbazepin, Valproic acid , Topiramate Other effective drugs other than anticonvulsants are Clonazepam , Baclofen, Diazepam, Pimozide IHS system, use the term facial pain not fulfilling other criteria to describe patients with atypical facial pain. This pain is a chronic pain syndrome which does not fall into other diagnostic categories. The major manifestation of AFP is a constant dull, aching pain without an apparent cause. It’s not paroxysmal and doesn’t precipitate by activity and doesn’t follow any anatomic pattern. Analgesics have no effect on AFP but tricyclic antidepressants can reduce the pain. It seems that psycho therapy has an important role in AFP treatment. Myofacial pain dysfunction syndrome (MPDS) is a muscular pain due to increased load and muscular hyperactivity. MPDS manifests as a dull pain with a tender trigger point in muscles, tendon and their fascias which are tender on palpation. The referral pain and autonomic symptoms can be detected on palpation of the trigger zone. The muscle relaxants (methocarbamol) and NSAIDs can relieve the symptoms. The amount of pain. Timepoint: Before and after intervention and 2-4 months after intervention. Method of measurement: Visual Analogue Scale. The metabolit of serotoninlike 5-hydroxy indole acetic acid (5-HIAA). Timepoint: Before ,after,2-4 month after intervention. Method of measurement: 24-hour urine. Vice chancellor for research, Shiraz University of Medical Sciences Approved 2011-12-19 The Ethics committee of Shiraz university of Medical Science Zand street, Shiraz, Central building of Fars University of Medical Science Shiraz Iran (Islamic Republic of)