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Conservative treatment of distal radius fracture is immobilisation with cast for 4-6 weeks. After removing the cast, it is common to still have pain, swelling and reduced mobility in the wrist. The aim of this study is to evaluate the influence of LLLT on the hand.
Patient with distal radius fractures are after removal of the cast are recruited form Bergen Emergency Department, where the are randomly divided into two groups with concealed allocation. Patient will be treated 3 times a week, for 3 week. After removal of the cast, the patients pain threshold, swelling, AROM, strength and function is measured. The patients will meet for following-up controls until 26 weeks after injury.
Changes in outcome measures during the study:
Due to covid 19 virus restrictions, we had to abandon the objective physical measurements as planned. Primary outcome measures were retrieved allowing no physical contact with the participants (Ipad, telephone or e-mail).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Level Laser therapy | Experimental | 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. |
|
| Placebo Low-Level Laser therapy | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Level Laser Therapy | Other | The laser is an infrared (invisible) 60 mW 904 nm, made by Irradia Midlaser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Function and pain | Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE), and questions about night pain/pain killers | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessed using Pressure Algometer | Pressure Algometer | 26 weeks |
| Swelling will be assessed using measurement tape | Swelling will be assessed using measurement tape |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Magnus Bjordal, Professor | University of Bergen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bergen Accident Emergency Hospital | Bergen | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35030040 | Derived | Saebo H, Naterstad IF, Joensen J, Stausholm MB, Bjordal JM. Pain and Disability of Conservatively Treated Distal Radius Fracture: A Triple-Blinded Randomized Placebo-Controlled Trial of Photobiomodulation Therapy. Photobiomodul Photomed Laser Surg. 2022 Jan;40(1):33-41. doi: 10.1089/photob.2021.0125. |
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| ID | Term |
|---|---|
| D003100 | Colles' Fracture |
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D000072039 | Fracture Dislocation |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| Placebo Low Level Laser therapy | Other | This i laser is not giving any irradiation, but is identical to the infrared (invisible) 60 mW 904 nm Irradia Midlaser, made by Irradia. |
|
| 26 weeks |
| Active range of motion will be assessed using goniometer | Active range of motion will be assessed using goniometer | 26 weeks |
| Strength will be assessed using dynamometer | Strength will be assessed using dynamometer | 26 weeks |
| D014947 |
| Wounds and Injuries |
| D011885 | Radius Fractures |
| D050723 | Fractures, Bone |
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |