Low-level Laser Therapy in Distal Radius Fractures

• Sponsor: University of Bergen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03014024
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 60
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colles' Fracture	Other: Low-Level Laser Therapy; Other: Placebo Low Level Laser therapy	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-blind Placebo-controlled Study of Low-level Laser Therapy After Removal of Cast in Distal Radius Fractures
• Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Function and pain [26 weeks]

   Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE), and questions about night pain/pain killers

Secondary Outcome Measures

1. Pain assessed using Pressure Algometer [26 weeks]

   Pressure Algometer

2. Swelling will be assessed using measurement tape [26 weeks]

   Swelling will be assessed using measurement tape

3. Active range of motion will be assessed using goniometer [26 weeks]

   Active range of motion will be assessed using goniometer

4. Strength will be assessed using dynamometer [26 weeks]

   Strength will be assessed using dynamometer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bergen Accident Emergency Hospital	Bergen		Norway

Sponsors and Collaborators

• University of Bergen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Humaira Sæbø, MS, University of Bergen
• ClinicalTrials.gov Identifier: NCT03014024
• Other Study ID Numbers: 2016/1633
• First Posted: Jan 9, 2017
• Last Update Posted: May 18, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Humaira Sæbø, MS, University of Bergen: Distal Radius Fracture; Low Level Laser Therapy
• Additional relevant MeSH terms: Colles' Fracture; Fractures, Bone; Radius Fractures

Study Results

No Results Posted as of May 18, 2022