Pranav Gupta1, Virendra Singh2, Sujata Sethi3, Arun Kumar4. 1. Department of Dentistry, SHKM Govt. Medical College, Mewat, Haryana India. 2. Department of Oral and Maxillofacial Surgery, PGIDS, Pt. B.D. Sharma University of Health Sciences, Rohtak, Haryana 124001 India. 3. Department of Psychiatry, PGIMS, Pt. B.D. Sharma University of Health Sciences, Rohtak, Haryana 124001 India. 4. Department of Community Medicine, SHKM Govt. Medical College, Mewat, Haryana 122107 India.
Abstract
AIM: To compare the efficacy of combined local anesthetic injection with 0.5 % bupivacaine and levosulpiride versus local anesthetic injection alone on outcome measures including levels of pain intensity and depression in the management of myofascial pain syndrome in orofacial region. PATIENTS AND METHODS: This was a prospective, randomized, controlled and open-label comparative clinical study. Seventy-four patients diagnosed to have myofascial pain syndrome and fulfilling the inclusion criteria were enrolled for the study. Patients were randomly assigned into 2 groups. Group A received local anesthetic injection (0.5 % bupivacaine) on trigger points and Group B received combined trigger point injection therapy and 50 mg of tablet Levosulpiride orally B.I.D. They were assessed for pain intensity and depression at baseline and at follow-up of 1, 4, 6 and 12 week intervals. RESULTS: The mean age of patients was 44.54 + 15.977 years in group A and 39.97 + 14.107 years in group B (P value = 0.2). Group A comprised of 25 females (67.567 %) and 12 males (32.432 %) while group B had 27 females (75 %) and 9 males (25 %). 70.27 % were diagnosed with moderate depression in group A and 75 % in group B. 18.91 % in group A and 19.44 % in group B were diagnosed with severe depression. When the VAS score and BDI score was compared at the follow-up intervals with the baseline scores in both treatment groups, the mean difference was highly significant at all the follow-up intervals. However when the relative efficacies of two interventions were compared between the two groups, improvement in pain was significant at all the follow-up intervals except the 1st week follow-up whereas the improvement in depression was non-significant at 1st and 4th week interval while it was highly significant at 6th and 12th week intervals. CONCLUSION: The combined therapy with trigger point injection and levosulpiride as antidepressant significantly reduces pain and depression in the study subjects suffering from chronic myofascial pain with moderate to severe depression in the orofacial region.
RCT Entities:
AIM: To compare the efficacy of combined local anesthetic injection with 0.5 % bupivacaine and levosulpiride versus local anesthetic injection alone on outcome measures including levels of pain intensity and depression in the management of myofascial pain syndrome in orofacial region. PATIENTS AND METHODS: This was a prospective, randomized, controlled and open-label comparative clinical study. Seventy-four patients diagnosed to have myofascial pain syndrome and fulfilling the inclusion criteria were enrolled for the study. Patients were randomly assigned into 2 groups. Group A received local anesthetic injection (0.5 % bupivacaine) on trigger points and Group B received combined trigger point injection therapy and 50 mg of tablet Levosulpiride orally B.I.D. They were assessed for pain intensity and depression at baseline and at follow-up of 1, 4, 6 and 12 week intervals. RESULTS: The mean age of patients was 44.54 + 15.977 years in group A and 39.97 + 14.107 years in group B (P value = 0.2). Group A comprised of 25 females (67.567 %) and 12 males (32.432 %) while group B had 27 females (75 %) and 9 males (25 %). 70.27 % were diagnosed with moderate depression in group A and 75 % in group B. 18.91 % in group A and 19.44 % in group B were diagnosed with severe depression. When the VAS score and BDI score was compared at the follow-up intervals with the baseline scores in both treatment groups, the mean difference was highly significant at all the follow-up intervals. However when the relative efficacies of two interventions were compared between the two groups, improvement in pain was significant at all the follow-up intervals except the 1st week follow-up whereas the improvement in depression was non-significant at 1st and 4th week interval while it was highly significant at 6th and 12th week intervals. CONCLUSION: The combined therapy with trigger point injection and levosulpiride as antidepressant significantly reduces pain and depression in the study subjects suffering from chronic myofascial pain with moderate to severe depression in the orofacial region.