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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


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
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