Myofascial Pain:Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine (ACP)
Primary Purpose
Myofascial Pain Syndromes
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
bupivacaine and acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndromes focused on measuring Myofascial pain syndrome, Acupuncture, Nonsteroidal anti-inflammatory agents, Muscle relaxants, central, Quality of life., muscle relaxants, analgesia
Eligibility 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
Sites / Locations
- Pain Setor of Federal University of Sao Paulo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
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.
Outcomes
Primary Outcome Measures
Pain relief
Secondary Outcome Measures
compare the analgesic action of acupuncture and trigger point injection combined with cyclobenzaprine and dipyrone
Full Information
NCT ID
NCT00635037
First Posted
March 5, 2008
Last Updated
March 12, 2008
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00635037
Brief Title
Myofascial Pain:Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine
Acronym
ACP
Official Title
Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine on Pain Relief of Patients With Myofascial Pain: Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndromes
Keywords
Myofascial pain syndrome, Acupuncture, Nonsteroidal anti-inflammatory agents, Muscle relaxants, central, Quality of life., muscle relaxants, analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
bupivacaine and acupuncture
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain relief
Time Frame
1year
Secondary Outcome Measure Information:
Title
compare the analgesic action of acupuncture and trigger point injection combined with cyclobenzaprine and dipyrone
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam CB Gazi, MD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Setor of Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
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Myofascial Pain:Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine
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