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Efficacy of Interferential Laser Therapy in Shoulder Pain (PI070046)

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT00694538
First received: May 29, 2008
Last updated: November 12, 2009
Last verified: November 2009
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Completion Date: November 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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).
Other Names:
  • Interference Laser Therapy.
  • Device Brand Name: Laser Sys. Stim 540(Mettler Electronics).
  • SN: 105XLS147 (first laser) and 105XLS148 (second laser).
Experimental: 2
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).
Other Names:
  • Interference Laser Therapy.
  • Device Brand Name: Laser Sys. Stim 540(Mettler Electronics).
  • SN: 105XLS147 (first laser) and 105XLS148 (second laser).

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

Locations
Spain
Hospital Ramon y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
Hospital Universitario Ramon y Cajal
Investigators
Principal Investigator: Ramon Montes-Molina, PT Hospital Ramon y Cajal
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: MONTES-MOLINA, RAMON, HOSPITAL RAMON Y CAJAL- IMSALUD.
ClinicalTrials.gov Identifier: NCT00694538     History of Changes
Other Study ID Numbers: PI070046, PI 070046
Study First Received: May 29, 2008
Last Updated: November 12, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by Hospital Universitario Ramon y Cajal:
Interferential laser therapy

Additional relevant MeSH terms:
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013