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

NCT ID: NCT01250184

Last Updated: 2014-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-09-30

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.

Conditions

Myofascial Pain Syndrome; Pain; Myofascial Trigger Point Pain; Musculoskeletal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical Therapy

Twelve sessions, 3 per week.

Group Type: ACTIVE_COMPARATOR

Physical therapy

Intervention Type: OTHER

Twelve sessions (3 per week)

Lidocaine injection

Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.

Group Type: ACTIVE_COMPARATOR

Lidocaine injection

Intervention Type: DRUG

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

Lidocaine injection + physical therapy

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

Group Type: EXPERIMENTAL

Lidocaine injection + physical therapy

Intervention Type: OTHER

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

Interventions

Physical therapy

Twelve sessions (3 per week)

Intervention Type: OTHER

Lidocaine injection

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

Intervention Type: DRUG

Lidocaine injection + physical therapy

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

Intervention Type: OTHER

Other Intervention Names

standardized therapeutic exercise program; blocking the Myofascial trigger point; blocking plus a standarized therapeutic exercise program

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Antioquia

OTHER

Sponsor Role: collaborator

Grupo Rehabilitacion en Salud

NETWORK

Sponsor Role: lead

Responsible Party

Luz Helena Lugo Agudelo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luz H Lugo Agudelo, Professor

Role: PRINCIPAL_INVESTIGATOR

Universidad de Antioquia Grupo Rehabilitacion en Salud

Locations

Clinica de Las Américas

Medellín, Antioquia, Colombia

Ips Universitaria

Medellín, Antioquia, Colombia

Countries

Colombia

Other Identifiers

GrupoRS0001

Identifier Type: -

Identifier Source: org_study_id