Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy.
Information source: Grupo Rehabilitacion en Salud
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myofascial Pain Syndrome; Pain; Myofascial Trigger Point Pain; Musculoskeletal Pain
Intervention: Physical therapy (Other); Lidocaine injection (Drug); Lidocaine injection + physical therapy (Other)
Phase: Phase 4
Status: Completed
Sponsored by: Grupo Rehabilitacion en Salud Official(s) and/or principal investigator(s): Luz H Lugo Agudelo, Professor, Principal Investigator, Affiliation: Universidad de Antioquia Grupo Rehabilitacion en Salud
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.
Clinical Details
Official title: Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy, Alone or in Combination: a Single-blind, Randomized, Controlled Clinical Trial.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Visual Analogue ScaleVisual Analogue Scale
Secondary outcome: PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue MedicationQuality of Life SF-36 PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication Quality of Life SF-36
Detailed description:
We propose a double blind randomized controlled clinical trial, in different health centers
in Medellin. The subjects are patients with myofascial trigger points (MTP) in muscles of
the shoulder girdle (levator scapulae, trapezius, infraspinatus) diagnosed by neck ans
shoulder pain lasting langer than 6 weeks, and that have not received rehabilitation
treatment and are not currently taking analgesic medications. We have calculated a sample of
45 patients in each group.
The physical and rehabilitation doctors who evaluated the patients and the nurse who
assessed the patients were blinded to treatment allocation. Physicians who performed the MTP
injection did not participate in the evaluation of primary and secondary outcomes. Physical
therapists who conducted the therapeutic exercise program did not participate in the
evaluation of primary and secondary outcomes.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Depression
- Fibromyalgia
- Cervical Radiculopathy
Locations and Contacts
Clinica de Las Américas, Medellin, Antioquia, Colombia
Ips Universitaria, Medellin, Antioquia, Colombia
Additional Information
Starting date: May 2009
Last updated: October 4, 2014
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