Low-level Laser Therapy on Wrist Fractures
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|ClinicalTrials.gov Identifier: NCT02749929|
Recruitment Status : Active, not recruiting
First Posted : April 25, 2016
Last Update Posted : November 14, 2019
Approximately 15,000 persons in Norway suffer from a wrist fractures during a year, making it the most prevalent fracture in this country. Treated conservatively, a cast is used for 4-6 weeks before removal. After discontinuation of the cast, physiotherapy is implemented to aid in improving range of motion and regaining function of the injured wrist. The pain after injury can affect the patient to a greater or lesser extent, and it is common to prescribe sick leave for shorter amounts of time after the injury.
Studies suggest that a physiotherapy intervention with Low Level Laser therapy (LLLT) may reduce pain and swelling after acute trauma, and potentially promote healing. The aim of this study is to evaluate the effect of LLLT on pain and function at 2, 4, 8 and 26 weeks after injury.
|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)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||A Double-blind Placebo-controlled Study of Low-level Laser Therapy on Wrist Fractures|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Low-Level Laser therapy
After inclusion in the study, a small window of approximately 1 cm2 opening will be made in the cast in order for the laser to make skin contact. The laser is a super pulsed infrared laser with a wavelength of 904 nm, belonging to laser class 3B. The light from the laser is not visible to the eye, and will not give any perceptible stimulus.
Low-Level Laser therapy (LLLT) will be given according to the recommended dosage from World Association of Laser Therapy (WALT). A LLLT dose of 3.6 Joules will be administered at two points over the fracture site.
Other: Low level laser therapy
The laser is an infrared (invisible) 60 mW 904 nm Irradia Midlaser
Placebo Comparator: Placebo Low-Level Laser therapy
After inclusion in the study, a small window of approximately 1 cm2 opening will be made in the cast in order for the placebo laser to make skin contact. The placebo laser is identical in apperance to a super pulsed infrared laser with a wavelength of 904 nm, belonging to laser class 3B. Since the light from the laser is invisible, neither the participant nor the therapist will know whether the laser is a placebo. The treatment time and number of treated points will be identical to group 1.
Other: Placebo Low Level Laser Therapy
The placebo laser is an identical device to the active laser, made by Irradia Midlaser
- Function and pain [ Time Frame: 26 weeks ]Function and will be assessed using Patient Rating Wrist and Hand Evaluation a (PRWHE), and questions about night pain/pain killers
- Pain by pressure [ Time Frame: 26 weeks ]Pain Pressure Threshold over distal radius will be assessed using Pressure Algometry
- Swelling [ Time Frame: 26 weeks ]Swelling will be assessed using measurement tape
- Active range of motion [ Time Frame: 26 weeks ]Active range of motion will be assessed using goniometer
- Grip- and pinch Strength [ Time Frame: 26 weeks ]Strength will be assessed using handheld 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): NCT02749929
|Bergen Accident Emergency Hospital|
|Study Director:||Jan Magnus Bjordal, Professor||University of Bergen|