Clinical trial NCT03014024: Low-level Laser Therapy in Distal Radius Fractures
Official title: A Double-blind Placebo-controlled Study of Low-level Laser Therapy After Removal of Cast in Distal Radius Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colles' Fracture
Keywords: Distal Radius Fracture
Low Level Laser Therapy
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Patients with distal radius fracture, with or without ulna fracture (Colles' fracture
* The breach must be closed
* after reduction: 0 degrees dorsal displacement of radius
* Under 5 degrees shortening of the radius
* Under 3 mm step in the joint
* 18+ years

Exclusion Criteria:

* People who do not speak Norwegian or English
* If the patient is pregnant
* Patient with Smith fracture
* Wounds over fracture area
* If the patient hav a peripheral neve injury
* If the patient had (previously) operated the wrist
* Persons with verified osteoporosis at the time of injury, systemic inflammatory disease (rheumatism), mental illness, stroke, Parkinson's disease, multiple sclerosis, cancer or congenital malformations in wrist
* If the laser treatment can not be started within 3 days after removal of the cast

Primary outcomes:
measure: Function and pain
timeFrame: 26 weeks
Secondary outcomes:
measure: Pain assessed using Pressure Algometer
timeFrame: 26 weeks
measure: Swelling will be assessed using measurement tape
timeFrame: 26 weeks
measure: Active range of motion will be assessed using goniometer
timeFrame: 26 weeks
measure: Strength will be assessed using dynamometer
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Bergen Accident Emergency Hospital
Study officials:
affiliation: University of Bergen
name: Jan Magnus Bjordal, Professor
role: STUDY_DIRECTOR
References:
citation: 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.