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Low-level Laser Therapy in Distal Radius Fractures

Primary Purpose

Colles' Fracture

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Low-Level Laser Therapy
Placebo Low Level Laser therapy
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colles' Fracture focused on measuring Distal Radius Fracture, Low Level Laser Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bergen Accident Emergency Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Low-Level Laser therapy

Placebo Low-Level Laser therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain assessed using Pressure Algometer
Pressure Algometer
Swelling will be assessed using measurement tape
Swelling will be assessed using measurement tape
Active range of motion will be assessed using goniometer
Active range of motion will be assessed using goniometer
Strength will be assessed using dynamometer
Strength will be assessed using dynamometer

Full Information

First Posted
January 6, 2017
Last Updated
May 16, 2022
Sponsor
University of Bergen
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1. Study Identification

Unique Protocol Identification Number
NCT03014024
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colles' Fracture
Keywords
Distal Radius Fracture, Low Level Laser Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-Level Laser therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Low-Level Laser therapy
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low-Level Laser Therapy
Intervention Description
The laser is an infrared (invisible) 60 mW 904 nm, made by Irradia Midlaser
Intervention Type
Other
Intervention Name(s)
Placebo Low Level Laser therapy
Intervention Description
This i laser is not giving any irradiation, but is identical to the infrared (invisible) 60 mW 904 nm Irradia Midlaser, made by Irradia.
Primary Outcome Measure Information:
Title
Function and pain
Description
Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE), and questions about night pain/pain killers
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Pain assessed using Pressure Algometer
Description
Pressure Algometer
Time Frame
26 weeks
Title
Swelling will be assessed using measurement tape
Description
Swelling will be assessed using measurement tape
Time Frame
26 weeks
Title
Active range of motion will be assessed using goniometer
Description
Active range of motion will be assessed using goniometer
Time Frame
26 weeks
Title
Strength will be assessed using dynamometer
Description
Strength will be assessed using dynamometer
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Magnus Bjordal, Professor
Organizational Affiliation
University of Bergen
Official's Role
Study Director
Facility Information:
Facility Name
Bergen Accident Emergency Hospital
City
Bergen
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35030040
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.
Results Reference
derived

Learn more about this trial

Low-level Laser Therapy in Distal Radius Fractures

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