Efficacy of Interferential Laser Therapy in Shoulder Pain

Shoulder Musculoskeletal Disorders Clinical Trial

— PI070046  

Official title:

Efficacy of Interferential Laser Therapy in Pain Reduction in Shoulder Musculoskeletal Pathologies.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694538
• Other study ID #: PI070046
• Secondary ID: PI 070046
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2008
• Last updated: November 12, 2009
• Start date: January 2008
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Shoulder Musculoskeletal Disorders

Intervention

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).

Locations

Country	Name	City	State
Spain	Hospital Ramon y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. doi: 10.1089/pho.2008.2315. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain will be evaluated by visual analog scale (VAS) at rest and during analytical shoulder movements.		Five minutes	No
Secondary	Shoulder Pain Disability Index (SPADI)		ten minutes	No