Back to resultsManual Therapy Treatment for Myofascial Pain
Primary Purpose
Myofascial Pain Syndromes
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Manual therapy
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndromes focused on measuring myofascial pain, trigger point injection, manual therapy
Eligibility Criteria
Inclusion Criteria:
- myofascial pain of neck and shoulder girdle, lasting ≥ 4 months, pain intensity ≥ 4.
Exclusion Criteria:
- arrhythmia
- heart block
- coagulopathy
- cognitive alterations and infection at the site
- patients using anticoagulants, and pregnant women
Sites / Locations
- Setor de Dor
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
single-arm studies
Arm Description
Manual therapy for one group
Outcomes
Primary Outcome Measures
Pain intensity
once a week for 8 weeks (T1 to T8)
Secondary Outcome Measures
Full Information
NCT ID
NCT01381380
First Posted
June 23, 2011
Last Updated
June 24, 2011
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01381380
Brief Title
Manual Therapy Treatment for Myofascial Pain
Official Title
Effect of Manual Therapy After Trigger Point Injection for Myofascial Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a pain intensity evaluation in patients with myofascial pain submitted kinesitherapy after trigger point injection.
Detailed Description
Randomized prospective study conducted on 30 patients of both genders ranging in age from 18 to 60 years, with neck and shoulder girdle Myofascial Pain Syndrome (MFS), with a duration of ≥ 4 months and pain intensity ≥ 4.
Trigger point injection of 1 mL 0.25% bupivacaine at each point, once a week for 8 weeks (T1 to T8).
Group 1: kinesiotherapy once a week for 8 weeks Group 2: not submitted to kinesiotherapy Evaluation of pain intensity on the first assessment (T0) and after 1, 2, 3, 4, 5, 6, 7, 8, and 9 weeks
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, trigger point injection, manual therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single-arm studies
Arm Type
Other
Arm Description
Manual therapy for one group
Intervention Type
Procedure
Intervention Name(s)
Manual therapy
Other Intervention Name(s)
massage, finger pressure, myofascial release, mobilization
Intervention Description
Manual therapy, once a week for 8 weeks
Primary Outcome Measure Information:
Title
Pain intensity
Description
once a week for 8 weeks (T1 to T8)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
myofascial pain of neck and shoulder girdle, lasting ≥ 4 months, pain intensity ≥ 4.
Exclusion Criteria:
arrhythmia
heart block
coagulopathy
cognitive alterations and infection at the site
patients using anticoagulants, and pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rioko K Sakata, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Setor de Dor
City
São Paulo
ZIP/Postal Code
04023-062
Country
Brazil
12. IPD Sharing Statement
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Manual Therapy Treatment for Myofascial Pain
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