Efficacy of Interferential Laser Therapy in Shoulder Pain - Full Text View

Sponsored by:	Hospital Universitario Ramon y Cajal
Information provided by:	Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:	NCT00694538

Purpose

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.

Condition	Intervention	Phase
Shoulder Musculoskeletal Disorders	Device: Interferential Laser therapy	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study
Official Title:	Efficacy of Interferential Laser Therapy in Pain Reduction in Shoulder Musculoskeletal Pathologies.

Further study details as provided by Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Shoulder Pain Disability Index (SPADI) [ Time Frame: ten minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 100 patients are being treated with a single laser beam over pain area.	Device: Interferential Laser therapy 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).
2: Experimental 100 patients are being treated with interferential laser from two independent sources	Device: Interferential Laser therapy 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).

Arms

Assigned Interventions

1: Active Comparator

100 patients are being treated with a single laser beam over pain area.

Device: Interferential Laser therapy

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).

2: Experimental

100 patients are being treated with interferential laser from two independent sources

Device: Interferential Laser therapy

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).

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694538

Contacts

Contact: Ramon Montes-Molina, PT

34-91-336-8458

rmontes.hrc@salud.madrid.org

Locations

Spain
Hospital Ramon y Cajal	Recruiting
Madrid, Spain, 28034
Contact: Ramon Montes-Molina, PT 34-91-336-8458 rmontes.hrc@salud.madrid.org
Principal Investigator: Ramon Montes-Molina, PT

Sponsors and Collaborators

Hospital Universitario Ramon y Cajal

Investigators

Principal Investigator:

Ramon Montes-Molina, PT

Hospital Ramon y Cajal

More Information

No publications provided

Responsible Party:	HOSPITAL RAMON Y CAJAL- IMSALUD. ( MONTES-MOLINA, RAMON )
Study ID Numbers:	PI070046, PI 070046
Study First Received:	May 29, 2008
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00694538
Health Authority:	Spain: Ministry of Health

Keywords provided by Hospital Universitario Ramon y Cajal:

Interferential laser therapy

Study placed in the following topic categories:

Musculoskeletal Diseases
Shoulder Pain
Pain

ClinicalTrials.gov processed this record on February 12, 2009