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

NCT01093209 | Completed Phase 2 DMC

• 1 other identifier: Ramón y Cajal Hospital
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome; Neuropathic Pain

Keywords

Carpal Tunnel Syndrome; Interferential laser therapy; Low-level laser therapy; Neuropathic pain; Median nerve compression

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  Visual Analogue Scale during wrist analitical movements.

  5 minutes

Secondary Outcomes (3)

• Disability Arm Shoulder and Hand questionnaire (DASH)

  15 minutes

• Boston Carpal Tunnel Questionnaire

  5 minutes

• Dinamometry

  5 minutes

Study Arms (2)

Conventional Laser Therapy

SHAM COMPARATOR

Device: Interferential Laser Therapy

Interferential Laser Therapy

ACTIVE COMPARATOR

Device: Interferential Laser Therapy

Interventions

Interferential Laser Therapy DEVICE

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.

Conventional Laser Therapy; Interferential Laser Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with severe hand traumatisms.
• Patients with cervical radiculopathy.
• Patients with Outlet Thoracic Syndrome.
• Patients bearing osteo syntheses material.
• Patients suffering tumoral pathology.

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Ramón y Cajal University Hospital

Madrid, Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Neuralgia

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ramon Montes-Molina, PT, MsC

  Unit of Physiotherapy

  PRINCIPAL INVESTIGATOR

• Fidel Martinez-Ruiz, Physicist

  Unit Biomechanics and Biomaterials

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 25, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2011
• Last Updated: June 28, 2011

Record last verified: 2010-03

Locations

ES (1)