Low-level Laser Therapy on Distal Radius Fractures
|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: NCT03014024|
Recruitment Status : Unknown
Verified January 2017 by Humaira Sæbø, University of Bergen.
Recruitment status was: Recruiting
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colles' Fracture||Other: Low-Level Laser Therapy Other: Placebo Low Level Laser therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind Placebo-controlled Study of Low-level Laser Therapy After Removal of Cast on Distal Radius Fractures|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||February 2019|
Experimental: Low-Level Laser therapy
After inclusion in the study, patients will be treated with LLLT. The laser is a super pulsed infrared laser with a wavelength of 904 nm, belonging to laser class 3B. Patient will be treated from dorsal side of the wrist on the fracture area, and distal ulna area from the palmar side. Total 20 second on each side (3 points), with 3,6 J/cm2. the light from the laser is not visible to the eye, and will not give any perceptible stimulus. The x-ray will be used to find the fracture line.
Other: Low-Level Laser Therapy
The laser is an infrared (invisible) 60 mW 904 nm, made by Irradia Midlaser
Placebo Comparator: Placebo Low-Level Laser therapy
After inclusion in the study, patients will be treated with placebo LLLT. This placebo laser is identical in appearance to the other super pulsed infrared laser with a wavelength of 904 nm, belonging to laser class 3B. Patient will be treated on the same areas, and have the same procedure and time. Since the light from the laser is invisible neither the participant nor the therapist will know whether the laser is a placebo.
Other: Placebo Low Level Laser therapy
This i laser is not giving any irradiation, but is identical to the infrared (invisible) 60 mW 904 nm Irradia Midlaser, made by Irradia.
- Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE) [ Time Frame: 26 weeks ]Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE)
- Pain assessed using Pressure Algometer [ Time Frame: 26 weeks ]Pressure Algometer
- Swelling will be assessed using measurement tape [ Time Frame: 26 weeks ]Swelling will be assessed using measurement tape
- Active range of motion will be assessed using goniometer [ Time Frame: 26 weeks ]Active range of motion will be assessed using goniometer
- Strength will be assessed using dynamometer [ Time Frame: 26 weeks ]Strength will be assessed using dynamometer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014024
|Contact: Humaira Sæbø, M.Sc||98856847 ext 47||Humaira.Sebo@uib.no|
|Contact: Jon Joensen, PhD||45048157 ext 47||Jon.Joensen@uib.no|
|Bergen Accident Emergency Hospital||Recruiting|
|Contact: Humaira Sæbø, M.Sc 98856847 ext 47 Humaira.Sebo@uib.no|
|Study Director:||Jan Magnus Bjordal, Professor||University of Bergen|