Efficacy of Interferential Laser Therapy in Shoulder Pain

NCT00694538 | Completed Phase 2 DMC

• 2 other identifiers: PI070046PI 070046
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Musculoskeletal Disorders

Keywords

Interferential laser therapy

Outcome Measures

Primary Outcomes (1)

• Pain will be evaluated by visual analog scale (VAS) at rest and during analytical shoulder movements.

  Five minutes

Secondary Outcomes (1)

• Shoulder Pain Disability Index (SPADI)

  ten minutes

Study Arms (2)

1

ACTIVE COMPARATOR

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

Device: Interferential Laser therapy

2

EXPERIMENTAL

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

Device: Interferential Laser therapy

Interventions

Interferential Laser therapy DEVICE

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).

Also known as: Interference Laser Therapy., Device Brand Name: Laser Sys. Stim 540(Mettler Electronics)., SN: 105XLS147 (first laser) and 105XLS148 (second laser).

1; 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute or chronic pain from musculoskeletal origin
• Age between 18 and 70 years

You may not qualify if:

• Brachial plexus palsy
• Neurological diseases
• Pacemakers
• Shoulder pain from cervical pathology
• Osteosynthesis material
• Fibromyalgia

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Ramon y Cajal

Madrid, Madrid, 28034, Spain

Location

Related Publications (2)

• 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.

  PMID: 19405858 BACKGROUND

• 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.

  PMID: 22507365 DERIVED

Study Officials

• Ramon Montes-Molina, PT

  Hospital Ramon y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 10, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: November 1, 2009
• Last Updated: November 13, 2009

Record last verified: 2009-11

Locations

ES (1)