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Trial record 42 of 312 for:    Pinched Nerve

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01093209
Recruitment Status : Completed
First Posted : March 25, 2010
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
Hospital Universitario Ramon y Cajal

Tracking Information
First Submitted Date  ICMJE March 24, 2010
First Posted Date  ICMJE March 25, 2010
Last Update Posted Date June 28, 2011
Study Start Date  ICMJE February 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2010)
Visual Analogue Scale (VAS) [ Time Frame: 5 minutes ]
Visual Analogue Scale during wrist analitical movements.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01093209 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2010)
  • Disability Arm Shoulder and Hand questionnaire (DASH) [ Time Frame: 15 minutes ]
  • Boston Carpal Tunnel Questionnaire [ Time Frame: 5 minutes ]
  • Dinamometry [ Time Frame: 5 minutes ]
    Power grip and pinch grip.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of the Interferential Laser Therapy in Pain Reduction in Carpal Tunnel Syndrome
Official Title  ICMJE Efficacy of the Interferential Laser Therapy in Pain Reduction in Carpal Tunnel Syndrome
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.
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Carpal Tunnel Syndrome
  • Neuropathic Pain
Intervention  ICMJE 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.
Study Arms
  • Sham Comparator: Conventional Laser Therapy
    Intervention: Device: Interferential Laser Therapy
  • Active Comparator: Interferential Laser Therapy
    Intervention: Device: Interferential Laser Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 27, 2011)
100
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2010)
106
Actual Study Completion Date April 2011
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01093209
Other Study ID Numbers  ICMJE Ramón y Cajal Hospital
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party EFFICACY OF THE INTERFERENTIAL LASER THERAPY IN THE REDUCTION OF PAIN IN CARPAL TUNNEL SYNDROME., Hospital Ramon y Cajal
Study Sponsor  ICMJE Hospital Universitario Ramon y Cajal
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ramon Montes-Molina, PT, MsC Unit of Physiotherapy
Study Director: Fidel Martinez-Ruiz, Physicist Unit Biomechanics and Biomaterials
PRS Account Hospital Universitario Ramon y Cajal
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP