Phase 4
N=127
Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy.
Myofascial Pain Syndrome · Pain · Myofascial Trigger Point Pain · Musculoskeletal Pain
Bottom Line
View on ClinicalTrials.gov: NCT01250184 ↗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
| Outcome | Result | p-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
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.