Efficacy of the Interferential Laser Therapy in Pain Reduction in Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome, Neuropathic Pain
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Interferential Laser Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Syndrome, Interferential laser therapy, Low-level laser therapy, Neuropathic pain, Median nerve compression
Eligibility 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.
Sites / Locations
- Ramón y Cajal University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Conventional Laser Therapy
Interferential Laser Therapy
Arm Description
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS)
Visual Analogue Scale during wrist analitical movements.
Secondary Outcome Measures
Disability Arm Shoulder and Hand questionnaire (DASH)
Boston Carpal Tunnel Questionnaire
Dinamometry
Power grip and pinch grip.
Full Information
NCT ID
NCT01093209
First Posted
March 24, 2010
Last Updated
June 27, 2011
Sponsor
Hospital Universitario Ramon y Cajal
1. Study Identification
Unique Protocol Identification Number
NCT01093209
Brief Title
Efficacy of the Interferential Laser Therapy in Pain Reduction in Carpal Tunnel Syndrome
Official Title
Efficacy of the Interferential Laser Therapy in Pain Reduction in Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Universitario Ramon y Cajal
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Neuropathic Pain
Keywords
Carpal Tunnel Syndrome, Interferential laser therapy, Low-level laser therapy, Neuropathic pain, Median nerve compression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional Laser Therapy
Arm Type
Sham Comparator
Arm Title
Interferential Laser Therapy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Interferential Laser Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
Visual Analogue Scale during wrist analitical movements.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Disability Arm Shoulder and Hand questionnaire (DASH)
Time Frame
15 minutes
Title
Boston Carpal Tunnel Questionnaire
Time Frame
5 minutes
Title
Dinamometry
Description
Power grip and pinch grip.
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramon Montes-Molina, PT, MsC
Organizational Affiliation
Unit of Physiotherapy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fidel Martinez-Ruiz, Physicist
Organizational Affiliation
Unit Biomechanics and Biomaterials
Official's Role
Study Director
Facility Information:
Facility Name
Ramón y Cajal University Hospital
City
Madrid
ZIP/Postal Code
28034
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy of the Interferential Laser Therapy in Pain Reduction in Carpal Tunnel Syndrome
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