CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 127 enrolled
Drug / intervention
Lidocaine injection +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01250184
NCT01250184Phase 4Completed

Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy, Alone or in Combination: a Single-blind, Randomized, Controlled Clinical Trial.

Grupo Rehabilitacion en Salud·interventional·Posted Nov 30, 2010·Updated Oct 10, 2014

In Brief

A Phase 4 clinical trial evaluating Physical therapy, Lidocaine injection, and 1 other intervention for Myofascial Pain Syndrome and 3 related conditions. Completed, enrolled 127 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesColombia

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2010
Enrollment StartMay 1, 2009
Primary CompletionJun 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.6 years ago

Interventions

Physical therapyother

Twelve sessions (3 per week)

Lidocaine injectiondrug

blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.

Lidocaine injection + physical therapyother

blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)