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Low-level Laser Therapy in Wrist 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 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

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, 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain by pressure
Pain Pressure Threshold over distal radius will be assessed using Pressure Algometry
Swelling
Swelling will be assessed using measurement tape
Active range of motion
Active range of motion will be assessed using goniometer
Grip- and pinch Strength
Strength will be assessed using handheld dynamometer

Full Information

First Posted
April 21, 2016
Last Updated
April 27, 2021
Sponsor
University of Bergen
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy
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1. Study Identification

Unique Protocol Identification Number
NCT02749929
Brief Title
Low-level Laser Therapy in Wrist Fractures
Official Title
A Double-blind Placebo-controlled Study of Low-level Laser Therapy in Wrist Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
April 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Approximately 15,000 persons in Norway suffer from 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.
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, 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.

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
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-Level Laser therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Low-Level Laser therapy
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low level laser therapy
Intervention Description
The laser is an infrared (invisible) 60 mW 904 nm Irradia Midlaser
Intervention Type
Other
Intervention Name(s)
Placebo Low Level Laser Therapy
Intervention Description
The placebo laser is an identical device to the active laser, made by Irradia Midlaser
Primary Outcome Measure Information:
Title
Function and pain
Description
Function and will be assessed using Patient Rating Wrist and Hand Evaluation a (PRWHE), and questions about night pain/pain killers
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Pain by pressure
Description
Pain Pressure Threshold over distal radius will be assessed using Pressure Algometry
Time Frame
26 weeks
Title
Swelling
Description
Swelling will be assessed using measurement tape
Time Frame
26 weeks
Title
Active range of motion
Description
Active range of motion will be assessed using goniometer
Time Frame
26 weeks
Title
Grip- and pinch Strength
Description
Strength will be assessed using handheld 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 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
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

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Low-level Laser Therapy in Wrist Fractures

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