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Comparison of Lidocaine Injection, Therapeutic Exercise and Two of Them for Myofascial Pain Treatment (Litemyo)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Grupo Rehabilitacion en Salud.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Universidad de Antioquia
Information provided by:
Grupo Rehabilitacion en Salud
ClinicalTrials.gov Identifier:
NCT01250184
First received: November 27, 2010
Last updated: June 14, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Myofascial Pain Syndrome
Pain
Myofascial Trigger Point
Anesthetics, Local
Physical Therapy Modalities
 Other: Physical therapy
Drug: Blocking the MTP with lidocaine injection
Other: blocking the MTP plus physical therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Lidocaine Injection, Therapeutic Exercise and Two of Them for Triggers Points in Myofascial Pain Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Grupo Rehabilitacion en Salud:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2009
Estimated Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Physical Therapy Other: Physical therapy
Twelve sessions (3 per week)
Other Name: standardized therapeutic exercise program
Drug: Blocking the MTP with lidocaine injection
blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.
Other Name: blocking the Myofascial trigger point
Other: blocking the MTP plus physical therapy
blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)
Other Name: blocking plus a standarized therapeutic exercise program
Active Comparator: Blocking the MTP
Blocking the myofascial trigger point (MTP)
 Drug: Blocking the MTP with lidocaine injection
blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.
Other Name: blocking the Myofascial trigger point
Experimental: Blocking the MTP plus physical therapy Drug: Blocking the MTP with lidocaine injection
blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.
Other Name: blocking the Myofascial trigger point

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250184

Locations
Colombia
Ips Universitaria
Medellin, Antioquia, Colombia
Clinica de Las Américas
Medellin, Antioquia, Colombia
Sponsors and Collaborators
Grupo Rehabilitacion en Salud
Universidad de Antioquia
Investigators
Principal Investigator: Luz H Lugo Agudelo, Professor Universidad de Antioquia Grupo Rehabilitacion en Salud
  More Information

No publications provided

Responsible Party: Universidad de Antioquia, Facultad de Medicina
ClinicalTrials.gov Identifier: NCT01250184     History of Changes
Other Study ID Numbers: GrupoRS0001
Study First Received: November 27, 2010
Last Updated: June 14, 2011
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Grupo Rehabilitacion en Salud:
myofascial, trigger point, analgesic block, physical therapy

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Fibromyalgia
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013