Comparison of Lidocaine Injection, Therapeutic Exercise and Two of Them for Myofascial Pain Treatment (Litemyo)
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| First Received Date ICMJE | November 27, 2010 | ||||
| Last Updated Date | June 14, 2011 | ||||
| Start Date ICMJE | May 2009 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01250184 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Lidocaine Injection, Therapeutic Exercise and Two of Them for Myofascial Pain Treatment | ||||
| Official Title ICMJE | Comparison of Lidocaine Injection, Therapeutic Exercise and Two of Them for Triggers Points in Myofascial Pain Treatment | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Estimated Completion Date | September 2011 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Colombia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01250184 | ||||
| Other Study ID Numbers ICMJE | GrupoRS0001 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Universidad de Antioquia, Facultad de Medicina | ||||
| Study Sponsor ICMJE | Grupo Rehabilitacion en Salud | ||||
| Collaborators ICMJE | Universidad de Antioquia | ||||
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| Information Provided By | Grupo Rehabilitacion en Salud | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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