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

NCT ID: NCT01093209

Last Updated: 2011-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carpal Tunnel Syndrome Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional Laser Therapy

Group Type SHAM_COMPARATOR

Interferential Laser Therapy

Intervention Type 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.

Interferential Laser Therapy

Group Type ACTIVE_COMPARATOR

Interferential Laser Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role lead

Responsible Party

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Hospital Ramon y Cajal

Principal Investigators

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Ramon Montes-Molina, PT, MsC

Role: PRINCIPAL_INVESTIGATOR

Unit of Physiotherapy

Fidel Martinez-Ruiz, Physicist

Role: STUDY_DIRECTOR

Unit Biomechanics and Biomaterials

Locations

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Ramón y Cajal University Hospital

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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Ramón y Cajal Hospital

Identifier Type: -

Identifier Source: org_study_id

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