NCT03014024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

3.5 years

First QC Date

January 6, 2017

Last Update Submit

May 16, 2022

Conditions

Colles' Fracture

Keywords

Distal Radius FractureLow Level Laser Therapy

Outcome Measures

Primary Outcomes (1)

  • Function and pain

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

    26 weeks

Secondary Outcomes (4)

  • Pain assessed using Pressure Algometer

    26 weeks

  • Swelling will be assessed using measurement tape

    26 weeks

  • Active range of motion will be assessed using goniometer

    26 weeks

  • Strength will be assessed using dynamometer

    26 weeks

Study Arms (2)

Low-Level Laser therapy

EXPERIMENTAL

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

Placebo Low-Level Laser therapy

PLACEBO COMPARATOR

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

Interventions

Low-Level Laser TherapyOTHER

The laser is an infrared (invisible) 60 mW 904 nm, made by Irradia Midlaser

Low-Level Laser therapy
Placebo Low Level Laser therapyOTHER

This i laser is not giving any irradiation, but is identical to the infrared (invisible) 60 mW 904 nm Irradia Midlaser, made by Irradia.

Placebo Low-Level Laser therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • + years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bergen Accident Emergency Hospital

Bergen, Norway

Location

Related Publications (1)

  • 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.

    PMID: 35030040DERIVED

MeSH Terms

Conditions

Colles' FractureWrist Fractures

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Fracture DislocationJoint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesRadius FracturesFractures, BoneWrist InjuriesArm Injuries

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Jan Magnus Bjordal, Professor

    University of Bergen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MS

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 9, 2017

Study Start

December 1, 2016

Primary Completion

June 1, 2020

Study Completion

December 1, 2021

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)