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

Myofascial Pain Syndromes Clinical Trial

— ACP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635037
• Other study ID #: ACP myofascial
• Secondary ID: No grant
• Status: Completed
• Phase: N/A
• First received: March 5, 2008
• Last updated: March 12, 2008
• Start date: June 2004
• Est. completion date: November 2006

Study information

• Verified date: March 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2006
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
Brazil	Pain Setor of Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief		1year	Yes
Secondary	compare the analgesic action of acupuncture and trigger point injection combined with cyclobenzaprine and dipyrone		1 year	Yes