Myofascial Pain:Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine - Full Text View

Purpose

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
Myofascial Pain Syndromes	Drug: bupivacaine and acupuncture

MedlinePlus related topics:

Acupuncture Fibromyalgia

Drug Information available for:

Bupivacaine Bupivacaine hydrochloride Dipyrone Cyclobenzaprine Cyclobenzaprine hydrochloride

U.S. FDA Resources

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

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

Pain relief [ Time Frame: 1year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

compare the analgesic action of acupuncture and trigger point injection combined with cyclobenzaprine and dipyrone [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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
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 trigger point injection of 0.25% bupivacaine (1 ml/point) twice a week, 10 mg/day cyclobenzaprine and 500 mg dipyrone every 8 h. acupuncture twice a week

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:- patients of both genders

chronic myofascial syndrome (duration of more than three months),
ranging in age from 18 to 65 year,
pain intensity score of 3 or higher (rated on a numerical scale ranging from 0 to 10)

Exclusion Criteria:

patients with disc herniation,
osteoarthritis,
vertebral collapse,
temporomandibular joint dysfunction,
infection, -
tumors,
coagulopathy, -
psychiatric disease,
cognitive disorders.
Patients who had used any type of analgesic or muscle relaxant agent 15 days before the study and those taking anticoagulants

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635037

Locations


Brazil, SP
	Pain Setor of Federal University of Sao Paulo
	Sao Paulo, SP, Brazil

Sponsors and Collaborators

Federal University of São Paulo

Investigators


Principal Investigator:	Miriam CB Gazi, MD	Federal University of Sao Paulo

More Information

Responsible Party:	Federal University of São Paulo ( Adriana Machado Issy/ Professor )
Study ID Numbers:	ACP myofascial, No grant
First Received:	March 5, 2008
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00635037
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:

Myofascial pain syndrome

Acupuncture

Nonsteroidal anti-inflammatory agents

Muscle relaxants, central

Quality of life.

muscle relaxants, analgesia

Study placed in the following topic categories:

Dipyrone

Muscular Diseases

Neuromuscular Diseases

Musculoskeletal Diseases

Myofascial Pain Syndromes

Fibromyalgia

Muscle Hypotonia

Quality of Life

Bupivacaine

Pain

Rheumatic Diseases

Cyclobenzaprine

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Tranquilizing Agents

Disease

Nervous System Diseases

Physiological Effects of Drugs

Psychotropic Drugs

Anesthetics

Central Nervous System Depressants

Neuromuscular Agents

Anesthetics, Local

Pharmacologic Actions

Antidepressive Agents, Tricyclic

Pathologic Processes

Analgesics, Non-Narcotic

Sensory System Agents

Muscle Relaxants, Central

Syndrome

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00635037