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

November 27, 2010
June 14, 2011
May 2009
June 2011   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01250184 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Lidocaine Injection, Therapeutic Exercise and Two of Them for Myofascial Pain Treatment
Comparison of Lidocaine Injection, Therapeutic Exercise and Two of Them for Triggers Points in Myofascial Pain Treatment

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Myofascial Pain Syndrome
  • Pain
  • Myofascial Trigger Point
  • Anesthetics, Local
  • Physical Therapy Modalities
  • 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: Physical Therapy
    Interventions:
    • Other: Physical therapy
    • Drug: Blocking the MTP with lidocaine injection
    • Other: blocking the MTP plus physical therapy
  • Active Comparator: Blocking the MTP
    Blocking the myofascial trigger point (MTP)
    Intervention: Drug: Blocking the MTP with lidocaine injection
  • Experimental: Blocking the MTP plus physical therapy
    Intervention: Drug: Blocking the MTP with lidocaine injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
September 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT01250184
GrupoRS0001
No
Universidad de Antioquia, Facultad de Medicina
Grupo Rehabilitacion en Salud
Universidad de Antioquia
Principal Investigator: Luz H Lugo Agudelo, Professor Universidad de Antioquia Grupo Rehabilitacion en Salud
Grupo Rehabilitacion en Salud
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP