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Efficacy of the Interferential Laser Therapy in Pain Reduction in Carpal Tunnel Syndrome

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT01093209
First received: March 24, 2010
Last updated: June 27, 2011
Last verified: March 2010
History of Changes
  Purpose

The purpose of this study is to determine the efficacy of the interferential laser therapy in the wrist and hand pain and disability reduction and force improvement in the carpal tunnel syndrome. Subjects are patients diagnosed of carpal tunnel syndrome who have been prescribed laser therapy. Settings: Ramon y Cajal Hospital. Department of Rehabilitation. Physical therapy unit. Electrotherapy section. Occupational Therapy. Department of Neurology.


Condition Intervention Phase
Carpal Tunnel Syndrome
Neuropathic Pain
 Device: Interferential Laser Therapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of the Interferential Laser Therapy in Pain Reduction in Carpal Tunnel Syndrome

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Visual Analogue Scale (VAS) [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]
    Visual Analogue Scale during wrist analitical movements.


Secondary Outcome Measures:
  • Disability Arm Shoulder and Hand questionnaire (DASH) [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]
  • Boston Carpal Tunnel Questionnaire [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]
  • Dinamometry [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]
    Power grip and pinch grip.


Estimated Enrollment: 100
Study Start Date: February 2010
Study Completion Date: April 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Conventional Laser Therapy Device: Interferential Laser Therapy
PROCEDURE: Interventional group: Two independents and identical probes. Energy dose per point and per probe: 5 J. Continuous emission. Treatment time:8 minutes. Sessions: 10. Frequency of the sessions: daily. Irradiation technique: handily, in contact and at 7 points over distal pathway of median nerve.Control group: Sham laser:650 nm.Scanning mode.Outpout power:1 mW.
Other Name: INTERFERENTIAL LASER THERAPY
Active Comparator: Interferential Laser Therapy Device: Interferential Laser Therapy
PROCEDURE: Interventional group: Two independents and identical probes. Energy dose per point and per probe: 5 J. Continuous emission. Treatment time:8 minutes. Sessions: 10. Frequency of the sessions: daily. Irradiation technique: handily, in contact and at 7 points over distal pathway of median nerve.Control group: Sham laser:650 nm.Scanning mode.Outpout power:1 mW.
Other Name: INTERFERENTIAL LASER THERAPY

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. Patient suffering pain from diagnosed carpal tunnel syndrome will receive conventional or interferential laser therapy. This is a comparative randomized and double blind clinical study. Two identical lasers in near infrared range will be used. Frequency of sessions: daily. Irradiated technique: manual, contact and punctual. Pain will be evaluated by visual analog scale at rest and during analytical wrist movement. Disability will be evaluated by the DASH and BOSTON questionnaire. Evaluation will take place at pre and post-treatment times.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed of Carpal Tunnel Syndrome by means of an Electromyography Study.
  • Patients with or not previous surgery.
  • Patients with an age of 18 years or older.
  • Patients having a signed informed consent.

Exclusion Criteria:

  • Patients with severe hand traumatisms.
  • Patients with cervical radiculopathy.
  • Patients with Outlet Thoracic Syndrome.
  • Patients bearing osteo syntheses material.
  • Patients suffering tumoral pathology.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093209

Locations
Spain
Ramón y Cajal University Hospital
Madrid, Spain, 28034
Sponsors and Collaborators
Hospital Universitario Ramon y Cajal
Investigators
Principal Investigator: Ramon Montes-Molina, PT, MsC Unit of Physiotherapy
Study Director: Fidel Martinez-Ruiz, Physicist Unit Biomechanics and Biomaterials
  More Information

No publications provided

Responsible Party: EFFICACY OF THE INTERFERENTIAL LASER THERAPY IN THE REDUCTION OF PAIN IN CARPAL TUNNEL SYNDROME., Hospital Ramon y Cajal
ClinicalTrials.gov Identifier: NCT01093209     History of Changes
Other Study ID Numbers: Ramón y Cajal Hospital
Study First Received: March 24, 2010
Last Updated: June 27, 2011
Health Authority: Spain: Ministry of Health

Keywords provided by Hospital Universitario Ramon y Cajal:
Carpal Tunnel Syndrome
Interferential laser therapy
Low-level laser therapy
Neuropathic pain
Median nerve compression

Additional relevant MeSH terms:
Cumulative Trauma Disorders
Carpal Tunnel Syndrome
Neuralgia
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Nerve Compression Syndromes
Sprains and Strains
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013