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Lidocaine injection + physiotherapy comparable to monotherapy for myofascial pain syndrome
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April 2016
Lidocaine injection + physiotherapy comparable to monotherapy for myofascial pain syndrome
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A
Treatment of myofascial pain syndrome with lidocaine injection and physical therapy, alone or in combination: a single blind, randomized, controlled clinical trial
BMC Musculoskelet Disord. 2016 Feb 24;17(1):101.Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
135 patients with myofascial pain syndrome located in the muscles of the shoulder were randomized to either physical therapy, lidocaine injection, or a combination of physical therapy and lidocaine injection, for the purpose of determining whether combination therapy is more effective than monotherapies for improving pain, function, and quality of life outcomes after 3 months. Results demonstrated that all relevant clinical outcomes were comparable between all study groups at final follow-up, suggesting that the combination of the two monotherapies was equally as effective as its singular components.
Publication Funding Details
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Funding:
Non-Industry funded
Sponsor:
University of Antioquia School of Medicine, 2013-2014 Sustainability Strategy of Universidad
Conflicts:
None disclosed
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
3/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
Myofascial pain syndrome (MPS) is often characterized by the presence of myofascial trigger points (MTrPs) and associated hypersensitive areas that induce pain, tenderness, and autonomic behaviour when manipulated. Current conservative treatments include ultrasound therapy, massage and stretching with aerosolized fluoromethane, and physiotherapy. However, whether or not a superior treatment (or combination of treatments) exists has yet to be determined, and thus, the current study was conducted.
What was the principal research question?
For patients with myofascial pain syndrome, did the combination of physical therapy and lidocaine injection (without epinephrine) demonstrate significantly improved pain ratings, function, quality of life, and depressive symptoms when compared to physical therapy or lidocaine injection alone, as assessed up to 3 months post-intervention?
Study Characteristics
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Population:
135 patients with myofascial trigger points (MTrPs) in the trapezius, the infraspinatus, and/or the levator scapulae were included in this study. Patients were required to have neck or shoulder pain last for more than 6 weeks prior to study initiation and have a pain score equal to or greater than 40 on a visual analogue scale (VAS) for pain.
Intervention:
PT+LI group: patients received combination therapy of both physical therapy and lidocaine injection of 0.2 mL 0.5% lidocaine via a 25 or 26 gauge needle at an angle of 30 degrees into the MTrP and surrounding subcutaneous tissue. (n=45, 41 completed follow-up; mean age= 37.2+/-11.1, M=6/F=32).
Comparison:
PT group: patients received physical therapy only. Physical therapy included 12 sessions (1-hour sessions, 3 times per week for 4 weeks) involving 10 minutes of hot pack and ultrasound therapy followed by deactivation of MTrPs by manual compression for 10 minutes and stretches specific to the muscle that was affected. (n=45, 43 completed follow-up; mean age= 42.6+/-9.7, M=7/F=36).
LI group: patients received lidocaine injection therapy alone (described above) (n=45, 43 completed follow-up; mean age= 37.7+/-11.8, M=10/F=33).
Outcomes:
Primary outcome measure included pain measured via a visual analogue scale (VAS) 1 month post-intervention. Secondary outcomes included VAS pain at 3 months post-intervention, and function (evaluated by the hand-back/hand-mouth maneuver), quality of life measured by SF-36, and depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) at both 1 months and 3 months post intervention.
Methods:
RCT: assessor-blinded, multi-centre
Time:
Evaluations were made at 1-month and 3-months post-intervention.
What were the important findings?
- VAS pain scores measured 1-month post-intervention were similar when patients who received combination therapy (PT+LI) were compared to patients who received physical therapy alone (PT group, p=0.56) and those who received lidocaine injection therapy alone (LI group, p=0.545).
- PHQ-9 and SF-36 subscale (measuring depression symptoms and quality of life, respectively) differences between groups were not significant after one-month post-treatment. When SF-36 subscales were analyzed individually, patients in the PT+LI group recorded significant improvements in health when compared to patients in the PT group (p=0.03). No statistical difference was observed between the LI group and the PT+LI group.
- VAS pain scores, PHQ-9 scores, and SF-36 scores were comparable between all study groups when measured at 3 months post-intervention (p>0.05).
- Right upper limb hand-back maneuver scores for patients in the PT and PT+LI groups were significantly higher when compared to patients who received LI therapy alone (p=0.013,p=0.016 respectively) at 1 month and 3 months post-intervention. Left upper limb hand-back maneuver scores, we well as hand-mouth maneuver scores were comparable between all study group at all follow-up points.
- Analgesic use was comparable between patients in all study groups. 4 patients in the PT+LI group and 2 patients in the LI group experienced localized hematomas. One participant in the LI group reported minimal bleeding; there were no complications recorded in the PT group.
What should I remember most?
For patients with myofascial pain syndrome (MPS), treatment via physiotherapy alone, lidocaine injection therapy alone, or combination therapy (physiotherapy and lidocaine injection) resulted in comparable outcomes at all relevant primary and secondary measures when measured at one and three months post-treatment.
How will this affect the care of my patients?
The results of this study suggest that physical therapy and lidocaine injection combination therapy may be similarly effective in improving pain, function, and quality of life outcomes when compared to patients who received either monotherapy at all follow-up points. Future randomized controlled trials with larger patient populations and more patient-focused functional outcomes should be conducted in order to corroborate this study's findings.
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