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

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093209
• Other study ID #: Ramón y Cajal Hospital
• Status: Completed
• Phase: Phase 2
• First received: March 24, 2010
• Last updated: June 27, 2011
• Start date: February 2010
• Est. completion date: April 2011

Study information

• Verified date: March 2010
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Neuralgia
• Neuropathic Pain
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Spain	Ramón y Cajal University Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	Visual Analogue Scale during wrist analitical movements.	5 minutes	Yes
Secondary	Disability Arm Shoulder and Hand questionnaire (DASH)		15 minutes	Yes
Secondary	Boston Carpal Tunnel Questionnaire		5 minutes	Yes
Secondary	Dinamometry	Power grip and pinch grip.	5 minutes	Yes