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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome; Neuropathic Pain
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Ramon y Cajal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	Visual Analogue Scale during wrist analitical movements.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability Arm Shoulder and Hand questionnaire (DASH)		15 minutes
Boston Carpal Tunnel Questionnaire		5 minutes
Dinamometry	Power grip and pinch grip.	5 minutes

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: March 24, 2010
• First Submitted That Met QC Criteria: March 24, 2010
• First Posted (Estimate): March 25, 2010

Study Record Updates

• Last Update Posted (Estimate): June 28, 2011
• Last Update Submitted That Met QC Criteria: June 27, 2011
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Neuropathic pain; Carpal Tunnel Syndrome; Low-level laser therapy; Interferential laser therapy; Median nerve compression
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome; Neuralgia
• Other Study ID Numbers: Ramón y Cajal Hospital