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| Tracking Information | |||||
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| First Received Date ICMJE | May 29, 2008 | ||||
| Last Updated Date | November 12, 2009 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pain will be evaluated by visual analog scale (VAS) at rest and during analytical shoulder movements. [ Time Frame: Five minutes ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00694538 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Shoulder Pain Disability Index (SPADI) [ Time Frame: ten minutes ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of Interferential Laser Therapy in Shoulder Pain | ||||
| Official Title ICMJE | Efficacy of Interferential Laser Therapy in Pain Reduction in Shoulder Musculoskeletal Pathologies. | ||||
| Brief Summary | The purpose of this study is to determine the advantages of the interferential laser therapy in shoulder pain reduction compared with the conventional low level laser therapy modality. |
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| Detailed Description | The spatiotemporal superposition of two independent and opposite beams of laser generates a constructive interference pattern that increases the therapeutic effects in the irradiated tissue. Patients diagnosed of shoulder pain from different musculoskeletal disorders will received conventional or interferential laser therapy. This is a comparative, randomized and double - blind clinical study. Two identical equipments of near infrared laser therapy will be used. Number of sessions: 15. Frequency of the sessions: daily. Irradiation technique: manual, contact and punctual.Pain will be evaluated by visual analog scale (VAS) at rest and during analytical shoulder movements (abduction, adduction, internal rotation, external rotation, flexion, extension) and by means of a pain and disability index (SPADI). Evaluations will take place at pre and post treatment. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study | ||||
| Condition ICMJE | Shoulder Musculoskeletal Disorders | ||||
| Intervention ICMJE | Device: Interferential Laser therapy | ||||
| Study Arms / Comparison Groups |
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| Publications * | Montes-Molina R, Madroñero-Agreda MA, Romojaro-Rodríguez AB, Gallego-Mendez V, Prados-Cabiedas C, Marques-Lucas C, Pérez-Ferreiro M, Martinez-Ruiz F. Efficacy of interferential low-level laser therapy using two independent sources in the treatment of knee pain. Photomed Laser Surg. 2009 Jun;27(3):467-71. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | November 2009 | ||||
| Primary Completion Date | December 2008 (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 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Spain | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00694538 | ||||
| Responsible Party | MONTES-MOLINA, RAMON, HOSPITAL RAMON Y CAJAL- IMSALUD. | ||||
| Study ID Numbers ICMJE | PI070046, PI 070046 | ||||
| Study Sponsor ICMJE | Hospital Universitario Ramon y Cajal | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hospital Universitario Ramon y Cajal | ||||
| Verification Date | November 2009 | ||||
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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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