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Myofascial Pain:Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine (ACP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00635037
First Posted: March 13, 2008
Last Update Posted: March 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine on Pain Relief of Patients With Myofascial Pain: Randomized Clinical Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pain relief [ Time Frame: 1year ]

Secondary Outcome Measures:
  • compare the analgesic action of acupuncture and trigger point injection combined with cyclobenzaprine and dipyrone [ Time Frame: 1 year ]

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
Experimental: A

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635037


Locations
Brazil
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: Adriana Machado Issy/ Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00635037     History of Changes
Other Study ID Numbers: ACP myofascial
No grant
First Submitted: March 5, 2008
First Posted: March 13, 2008
Last Update Posted: March 13, 2008
Last Verified: March 2008

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

Additional relevant MeSH terms:
Muscle Relaxants, Central
Myofascial Pain Syndromes
Fibromyalgia
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Bupivacaine
Cyclobenzaprine
Amitriptyline
Dipyrone
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Neuromuscular Agents
Tranquilizing Agents
Analgesics, Non-Narcotic
Analgesics
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents