Low-level Laser Therapy on Wrist Fractures

• ClinicalTrials.gov Identifier: NCT02749929
• Recruitment Status: Active, not recruiting
• First Posted: April 25, 2016
• Last Update Posted: November 14, 2019
• Sponsor: University of Bergen
• Collaborator: Norwegian Fund for Postgraduate Training in Physiotherapy
• Information provided by (Responsible Party): Humaira Sæbø, University of Bergen

Study Description

Brief Summary:

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

Detailed Description:

Patients with wrist fractures are recruited from Bergen Municipal Emergency Ward, where they are randomly divided into two groups with concealed allocation. The fracture is immobilized with a cast of paris, with a small opening where Low Level Laser therapy can be administered in skin contact. The patients will receive treatment 3 times a week, for 3 weeks. After discontinuation of the cast, the patients swelling, pain, grip strength and function of the wrist is measured. The patients will meet for follow-up controls until 26 weeks after injury.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Pain by pressure [ Time Frame: 26 weeks ]
   Pain Pressure Threshold over distal radius will be assessed using Pressure Algometry
2. Swelling [ Time Frame: 26 weeks ]
   Swelling will be assessed using measurement tape
3. Active range of motion [ Time Frame: 26 weeks ]
   Active range of motion will be assessed using goniometer
4. Grip- and pinch Strength [ Time Frame: 26 weeks ]
   Strength will be assessed using handheld dynamometer

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Patients with distal radiusfraktur, with or without ulna fracture Colles' fracture
• The breach must be closed
• Under 10 degrees dorsal displacement of radius
• Under 5mm 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 have a peripheral nerve injury
• If the patient had (previously) operated 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 fracture

Contacts and Locations

Locations

Norway

Bergen Accident Emergency Hospital

Bergen, Norway

Sponsors and Collaborators

University of Bergen

Norwegian Fund for Postgraduate Training in Physiotherapy

Investigators

• Study Director: Jan Magnus Bjordal, Professor; University of Bergen

More Information

• Responsible Party: Humaira Sæbø, MS, University of Bergen
• ClinicalTrials.gov Identifier: NCT02749929
• Other Study ID Numbers: 569093
• First Posted: April 25, 2016
• Last Update Posted: November 14, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Humaira Sæbø, University of Bergen:

Distal radius fracture, Low Level Laser Therapy

Additional relevant MeSH terms:

Colles' Fracture; Fractures, Bone; Wounds and Injuries; Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Radius Fractures