Clinical trial NCT01250184
Conditions: Myofascial Pain Syndrome Pain Myofascial Trigger Point Pain Musculoskeletal Pain
Keywords: Myofascial pain Trigger points. Lidocaine injection. Physical therapy
Sponsor: Grupo Rehabilitacion en Salud
Start date: 2009-05-01; Completion date: 2011-09-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Twelve sessions, 3 per week. arm 2: Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose. arm 3: Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.
Interventions: intervention 1: Physical therapy intervention 2: Lidocaine injection intervention 3: Lidocaine injection + physical therapy
Intervention descriptions: intervention 1: Twelve sessions (3 per week) intervention 2: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose. intervention 3: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)

Protocol documents: