Efficacy of Interferential Laser Therapy in Shoulder Pain - Tabular View

Tracking Information

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.

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 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

Active Comparator: 100 patients are being treated with a single laser beam over pain area.
Experimental: 100 patients are being treated with interferential laser from two independent sources

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

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:

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

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

Principal Investigator:

Ramon Montes-Molina, PT

Hospital Ramon y Cajal

Information Provided By

Hospital Universitario Ramon y Cajal

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP