Overview

This trial is active, not recruiting.

Conditions myofascial pain syndrome, pain, myofascial trigger point, anesthetics, local, physical therapy modalities
Treatments physical therapy, blocking the mtp with lidocaine injection, blocking the mtp plus physical therapy
Phase phase 4
Sponsor Grupo Rehabilitacion en Salud
Collaborator Universidad de Antioquia
Start date May 2009
End date June 2011
Trial size 150 participants
Trial identifier NCT01250184, GrupoRS0001

Summary

Objective: To determine if the combination of blocking the Myofascial trigger point (MTP) plus a standardized therapeutic exercise program, is more effective than only the blocking or the therapeutic exercise; to relieve the pain and improve the function and the quality of life in a Group of patients con MTP in the shoulder girdle and the neck.

Methods: We propose a double blind randomized controlled clinical trial, in different health centers in Medellin. The subjects are patients with 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.

Primary outcomes: Pain 4 weeks later wich will be measured in a VAS (Visual analogue scale) a successful treatment is defined as a reduction in pain in 20% from the initial score 4 weeks after the first evaluation.

Secondary outcomes SF-36 bodily pain scale Function measured with the hand back and hand mouth maneuvers. Complications and adverse reactions Need for rescue medication.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
physical therapy standardized therapeutic exercise program
Twelve sessions (3 per week)
blocking the mtp with lidocaine injection blocking the Myofascial trigger point
blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.
blocking the mtp plus physical therapy blocking plus a standarized therapeutic exercise program
blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)
(Active Comparator)
Blocking the myofascial trigger point (MTP)
blocking the mtp with lidocaine injection blocking the Myofascial trigger point
blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.
(Experimental)
blocking the mtp with lidocaine injection blocking the Myofascial trigger point
blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.

Primary Outcomes

Measure
Pain 4 weeks later wich will be measured in a VAS (Visual analogue scale) a successful treatment is defined as a reduction in pain in 20% from the initial score 4 weeks after the first evaluation
time frame: 4 weeks

Secondary Outcomes

Measure
SF-36 bodily pain scale Function measured with the hand back and hand mouth maneuvers. Complications and adverse reactions Need for rescue medication
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Comparison of Lidocaine Injection, Therapeutic Exercise and Two of Them for Triggers Points in Myofascial Pain Treatment
Principal investigator Luz H Lugo Agudelo, Professor
Description e propose a double blind randomized controlled clinical trial, in different health centers in Medellin. The subjects are patients with 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. Primary outcomes: Pain 4 weeks later wich will be measured in a VAS (Visual analogue scale) a successful treatment is defined as a reduction in pain in 20% from the initial score 4 weeks after the first evaluation. Secondary outcomes SF-36 bodily pain scale Function measured with the hand back and hand mouth maneuvers. Complications and adverse reactions Need for rescue medication.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Grupo Rehabilitacion en Salud.