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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00635037
First received: March 5, 2008
Last updated: March 12, 2008
Last verified: March 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: March 5, 2008
Last Updated: March 12, 2008
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

Additional relevant MeSH terms:
Muscle Relaxants, Central
Fibromyalgia
Myofascial Pain Syndromes
Syndrome
Disease
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Rheumatic Diseases
Amitriptyline
Anti-Inflammatory Agents, Non-Steroidal
Bupivacaine
Cyclobenzaprine
Dipyrone
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, Local
Anti-Inflammatory Agents
Antidepressive Agents
Antidepressive Agents, Tricyclic
Antirheumatic Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neuromuscular Agents

ClinicalTrials.gov processed this record on November 23, 2014