Efficacy of Interferential Laser Therapy in Shoulder Pain (PI070046)
November 12, 2009 updated by: Hospital Universitario Ramon y Cajal
Efficacy of Interferential Laser Therapy in Pain Reduction in Shoulder Musculoskeletal Pathologies.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Madrid, Spain, 28034
- Hospital Ramon y Cajal
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
100 patients are being treated with a single laser beam over pain area.
|
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).
Other Names:
|
|
Experimental: 2
100 patients are being treated with interferential laser from two independent sources
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain will be evaluated by visual analog scale (VAS) at rest and during analytical shoulder movements.
Time Frame: Five minutes
|
Five minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Shoulder Pain Disability Index (SPADI)
Time Frame: ten minutes
|
ten minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ramon Montes-Molina, PT, Hospital Ramon y Cajal
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
May 29, 2008
First Submitted That Met QC Criteria
June 9, 2008
First Posted (Estimate)
June 10, 2008
Study Record Updates
Last Update Posted (Estimate)
November 13, 2009
Last Update Submitted That Met QC Criteria
November 12, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI070046
- PI 070046
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.