Pain Clinical Trial
Official title:
Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy, Alone or in Combination: a Single-blind, Randomized, Controlled Clinical Trial.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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