Official Title: “Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine on Pain Relief of Patients With Myofascial Pain: Randomized Clinical Study”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2005

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• 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.

Primary Measures

• Pain relief
  • Time Frame: 1year
    Safety Issue?: Yes

Secondary Measures

• compare the analgesic action of acupuncture and trigger point injection combined with cyclobenzaprine and dipyrone
  • Time Frame: 1 year
    Safety Issue?: Yes

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Federal University of São Paulo

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00635037

Study ID Number: ACP myofascial

ClinicalTrials.gov Identifier: NCT00635037

Health Authority: Brazil: National Committee of Ethics in Research