Efficacy of Interferential Laser Therapy in Shoulder Pain (PI070046)
Primary Purpose
Shoulder Musculoskeletal Disorders
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Interferential Laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Musculoskeletal Disorders focused on measuring Interferential laser therapy
Eligibility Criteria
Inclusion Criteria:
- Acute or chronic pain from musculoskeletal origin
- Age between 18 and 70 years
Exclusion Criteria:
- Brachial plexus palsy
- Neurological diseases
- Pacemakers
- Shoulder pain from cervical pathology
- Osteosynthesis material
- Fibromyalgia
Sites / Locations
- Hospital Ramon y Cajal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
100 patients are being treated with a single laser beam over pain area.
100 patients are being treated with interferential laser from two independent sources
Outcomes
Primary Outcome Measures
Pain will be evaluated by visual analog scale (VAS) at rest and during analytical shoulder movements.
Secondary Outcome Measures
Shoulder Pain Disability Index (SPADI)
Full Information
NCT ID
NCT00694538
First Posted
May 29, 2008
Last Updated
November 12, 2009
Sponsor
Hospital Universitario Ramon y Cajal
1. Study Identification
Unique Protocol Identification Number
NCT00694538
Brief Title
Efficacy of Interferential Laser Therapy in Shoulder Pain
Acronym
PI070046
Official Title
Efficacy of Interferential Laser Therapy in Pain Reduction in Shoulder Musculoskeletal Pathologies.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Universitario Ramon y Cajal
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Musculoskeletal Disorders
Keywords
Interferential laser therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
100 patients are being treated with a single laser beam over pain area.
Arm Title
2
Arm Type
Experimental
Arm Description
100 patients are being treated with interferential laser from two independent sources
Intervention Type
Device
Intervention Name(s)
Interferential Laser therapy
Other Intervention Name(s)
Interference Laser Therapy., Device Brand Name: Laser Sys. Stim 540(Mettler Electronics)., SN: 105XLS147 (first laser) and 105XLS148 (second laser).
Intervention Description
Two GaAlAs laser (810 nm, 100mW)were used. In the interferential laser treatment, two probes were simultaneously applied. In the conventional laser group, only one probe was switched on. Laser was applied at five points over the pain area. The laser emission mode was continuous with an energy dose of 6 joules per point and session, a power density of 1.09 w/cm2 and an irradiation time per point of 60 s. The average output power was 100 mW and the total energy dose delivered in a patient session was 30 J. Every treatment was along 15 sessions. Hence, the accumulated energy delivered on the whole was 450 Joules for the conventional group of patients (using one beam) and 900 Joules for the interferential one (using two beams).
Primary Outcome Measure Information:
Title
Pain will be evaluated by visual analog scale (VAS) at rest and during analytical shoulder movements.
Time Frame
Five minutes
Secondary Outcome Measure Information:
Title
Shoulder Pain Disability Index (SPADI)
Time Frame
ten minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute or chronic pain from musculoskeletal origin
Age between 18 and 70 years
Exclusion Criteria:
Brachial plexus palsy
Neurological diseases
Pacemakers
Shoulder pain from cervical pathology
Osteosynthesis material
Fibromyalgia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramon Montes-Molina, PT
Organizational Affiliation
Hospital Ramon y Cajal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
19405858
Citation
Montes-Molina R, Madronero-Agreda MA, Romojaro-Rodriguez AB, Gallego-Mendez V, Prados-Cabiedas C, Marques-Lucas C, Perez-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. doi: 10.1089/pho.2008.2315.
Results Reference
background
PubMed Identifier
22507365
Citation
Montes-Molina R, Prieto-Baquero A, Martinez-Rodriguez ME, Romojaro-Rodriguez AB, Gallego-Mendez V, Martinez-Ruiz F. Interferential laser therapy in the treatment of shoulder pain and disability from musculoskeletal pathologies: a randomised comparative study. Physiotherapy. 2012 Jun;98(2):143-50. doi: 10.1016/j.physio.2011.02.007. Epub 2011 May 28.
Results Reference
derived
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Efficacy of Interferential Laser Therapy in Shoulder Pain
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