Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy.
1 other identifier
interventional
127
1 country
2
Brief Summary
Background: Myofascial pain syndrome (MPS) of the shoulder girdle and cervical region is a common musculoskeletal problem that is often chronic or recurrent. It has demonstrated the effectiveness of different treatments such as exercise, injection but not comparing them with each other. The objective of this research was to demonstrate whether lidocaine injection into trigger points combined with a physical therapy program was more effective than each separatetreatment in improving pain, function and quality of life in a group of patients with myofascial pain syndrome (MPS) of the shoulder girdle and cervical region. Design: Single-blind, randomized, controlled clinical trial with three parallel groups in the departments of physical medicine and rehabilitation of two urban hospitals. There were 127 patients with myofascial pain in the shoulder girdle for more than six weeks in length and pain greater than 40 mm on the visual analog scale (VAS). There were three intervention groups: physical therapy (PT), lidocaine injection (LI), or the combination of both (PT + LI). The primary outcome at one month was the VAS, and the secondary outcomes were measured using the SF36 pain scaleat one and three months. Keywords: Myofascial pain, trigger points, lidocaine injection, physical therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2009
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 27, 2010
CompletedFirst Posted
Study publicly available on registry
November 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
October 10, 2014
CompletedOctober 10, 2014
October 1, 2014
2.1 years
November 27, 2010
September 27, 2014
October 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Visual Analogue Scale
VAS with a score of 0-100, where 100 is the value representing the highest degree of pain and 0 the lowest. Successful treatment was defined as a reduction in pain of at least 20% of the previous score on the VAS after 4 weeks of the initial evaluation, or 14 mm on the VAS; this scale is a reliable pain assessment measure that has been validated previously
4 weeks
Visual Analogue Scale
VAS with a score of 0-100, where 100 is the value representing the highest degree of pain and 0 the lowest. Successful treatment was defined as a reduction in pain of at least 20% of the previous score on the VAS after 4 weeks of the initial evaluation, or 14 mm on the VAS; this scale is a reliable pain assessment measure that has been validated previously
12 weeks
Secondary Outcomes (4)
PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication
4 weeks
Quality of Life SF-36
4 weeks
PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication
12 weeks
Quality of Life SF-36
12 weeks
Study Arms (3)
Physical Therapy
ACTIVE COMPARATORTwelve sessions, 3 per week.
Lidocaine injection
ACTIVE COMPARATORBlocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.
Lidocaine injection + physical therapy
EXPERIMENTALBlocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.
Interventions
Twelve sessions (3 per week)
blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.
blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)
Eligibility Criteria
You may qualify if:
- Cervical Pain at least six weeks
- At least 40 mm in the VAS
- They cannot been received treatment like physical therapy or analgesics
- Maximum score of PHQ 16 points
You may not qualify if:
- Depression
- Fibromyalgia
- Cervical Radiculopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grupo Rehabilitacion en Saludlead
- Universidad de Antioquiacollaborator
Study Sites (2)
Clinica de Las Américas
Medellín, Antioquia, Colombia
Ips Universitaria
Medellín, Antioquia, Colombia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The therapists were not the same throughout the investigation, however all were standardized to interventions; especilaistas doctors who applied the injections were different. No specific measure of patient-centered operation is used.
Results Point of Contact
- Title
- Dr. Luz Helena Lugo, Head of Research Group Rehabilitation in Health
- Organization
- university of Antioquia, Research Group Rehabilitation in Health
Study Officials
- PRINCIPAL INVESTIGATOR
Luz H Lugo Agudelo, Professor
Universidad de Antioquia Grupo Rehabilitacion en Salud
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 27, 2010
First Posted
November 30, 2010
Study Start
May 1, 2009
Primary Completion
June 1, 2011
Study Completion
September 1, 2011
Last Updated
October 10, 2014
Results First Posted
October 10, 2014
Record last verified: 2014-10