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Phase 4 N=127 Randomized Single-blind Treatment

Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy.

Myofascial Pain Syndrome · Pain · Myofascial Trigger Point Pain · Musculoskeletal Pain

Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Visual Analogue Scale — 40.8; 44.2; 37.8 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Physical therapy (Other); Lidocaine injection (Drug); Lidocaine injection + physical therapy (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Grupo Rehabilitacion en Salud
Primary completion
Jun 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Analogue Scale
21.6; 28.8; 28.2
PRIMARY
Visual Analogue Scale
21.6; 28.8; 28.2
SECONDARY
PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication
3.98; 3.16; 4.12
SECONDARY
Quality of Life SF-36
70.5; 70.23; 69.76; 66.58; 61.19; 65.66
SECONDARY
PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication
3.98; 3.16; 4.12
SECONDARY
Quality of Life SF-36
70.5; 70.23; 69.76; 66.58; 61.19; 65.66

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01250184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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