Clinical trial NCT01250184: Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy.
Official title: Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy, Alone or in Combination: a Single-blind, Randomized, Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myofascial Pain Syndrome
Pain
Myofascial Trigger Point Pain
Musculoskeletal Pain
Keywords: Myofascial pain
Trigger points.
Lidocaine injection.
Physical therapy
Lead sponsor: Grupo Rehabilitacion en Salud
Sponsor class: NETWORK
Collaborators: name: Universidad de Antioquia
First posted: 2010-11-30
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 4 weeks
measure: Visual Analogue Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication
timeFrame: 4 weeks
measure: Quality of Life SF-36
timeFrame: 4 weeks
measure: PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication
timeFrame: 12 weeks
measure: Quality of Life SF-36
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Clinica de Las Américas
state: Antioquia
city: Medellin
country: Colombia
facility: Ips Universitaria
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia Grupo Rehabilitacion en Salud
name: Luz H Lugo Agudelo, Professor
role: PRINCIPAL_INVESTIGATOR
References: