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

NCT ID: NCT00635037

Last Updated: 2008-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2006-11-30

Brief 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.

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.

Conditions

Myofascial Pain Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

bupivacaine and acupuncture

Intervention Type: DRUG

• 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Federal University of São Paulo

Principal Investigators

Miriam CB Gazi, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Pain Setor of Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

No grant

Identifier Type: -

Identifier Source: secondary_id

ACP myofascial

Identifier Type: -

Identifier Source: org_study_id