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Sponsored by: |
Federal University of São Paulo |
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Information provided by: | Federal University of São Paulo |
ClinicalTrials.gov Identifier: | NCT00635037 |
CONTEXT AND OBJECTIVE: Myofascial syndrome is the most frequent condition of chronic pain. The objective of the present study was to compare the analgesic action of acupuncture and trigger point injection combined with cyclobenzaprine and dipyrone.
DESIGN AND SETTING: A randomized study was performed at the Pain Clinic. METHODS: Thirty patients were divided into two groups: G1 received trigger point injection of 0.25% bupivacaine (1 ml/point) twice a week, 10 mg/day cyclobenzaprine and 500 mg dipyrone every 8 h. G2 was submitted to classical and trigger point acupuncture twice a week. The patients were asked to continue physical exercise. The following parameters were evaluated: pain intensity rated on a numerical and verbal scale, quality of life before and four weeks after treatment, and quality of analgesia.
Condition | Intervention |
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Myofascial Pain Syndromes |
Drug: bupivacaine and acupuncture |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine on Pain Relief of Patients With Myofascial Pain: Randomized Clinical Study |
Enrollment: | 30 |
Study Start Date: | June 2004 |
Study Completion Date: | November 2006 |
Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
G1 (n=15)received trigger point injection of 0.25% bupivacaine (1 ml/point) twice a week, 10 mg/day cyclobenzaprine and 500 mg dipyrone every 8 h. G2(n=15) was submitted to classical and trigger point acupuncture twice a week. |
Drug: bupivacaine and acupuncture
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Among the 39 patients selected, nine (3 in group 1 and 6 in group 2) were excluded from the study because they did not attend the visits scheduled for the procedures and assessment or because they did not respond to the questionnaires.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:- patients of both genders
Exclusion Criteria:
Brazil, SP | |
Pain Setor of Federal University of Sao Paulo | |
Sao Paulo, SP, Brazil |
Principal Investigator: | Miriam CB Gazi, MD | Federal University of Sao Paulo |
Responsible Party: | Federal University of São Paulo ( Adriana Machado Issy/ Professor ) |
Study ID Numbers: | ACP myofascial, No grant |
Study First Received: | March 5, 2008 |
Last Updated: | March 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00635037 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research |
Myofascial pain syndrome Acupuncture Nonsteroidal anti-inflammatory agents |
Muscle relaxants, central Quality of life. muscle relaxants, analgesia |
Anti-Inflammatory Agents Psychotropic Drugs Quality of Life Anesthetics Pain Neuromuscular Diseases Musculoskeletal Diseases Muscle Relaxants, Central Anti-Inflammatory Agents, Non-Steroidal Analgesics Antidepressive Agents Tranquilizing Agents Myofascial Pain Syndromes |
Fibromyalgia Central Nervous System Depressants Rheumatic Diseases Anesthetics, Local Cyclobenzaprine Antidepressive Agents, Tricyclic Dipyrone Muscular Diseases Analgesics, Non-Narcotic Muscle Hypotonia Bupivacaine Peripheral Nervous System Agents Antirheumatic Agents |
Anti-Inflammatory Agents Physiological Effects of Drugs Psychotropic Drugs Anesthetics Neuromuscular Agents Pathologic Processes Neuromuscular Diseases Musculoskeletal Diseases Sensory System Agents Syndrome Muscle Relaxants, Central Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Antidepressive Agents |
Tranquilizing Agents Disease Fibromyalgia Myofascial Pain Syndromes Nervous System Diseases Central Nervous System Depressants Rheumatic Diseases Pharmacologic Actions Anesthetics, Local Antidepressive Agents, Tricyclic Cyclobenzaprine Dipyrone Muscular Diseases Analgesics, Non-Narcotic Bupivacaine |