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Low-level Laser Therapy on Wrist Fractures

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ClinicalTrials.gov Identifier: NCT02749929
Recruitment Status : Unknown
Verified May 2017 by Humaira Sæbø, University of Bergen.
Recruitment status was:  Recruiting
First Posted : April 25, 2016
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by (Responsible Party):
Humaira Sæbø, University of Bergen

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : June 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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




Primary Outcome Measures :
  1. Function [ Time Frame: 26 weeks ]
    Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE)


Secondary Outcome Measures :
  1. Pain [ Time Frame: 26 weeks ]
    Pressure Algometer

  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. Strength [ Time Frame: 26 weeks ]
    Strength will be assessed using dynamometer



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749929


Contacts
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Contact: Humaira Sæbø, Msc Science 98856847 ext +47 humaira.sebo@uib.no
Contact: Jan Magnus Bjordal, Professor 91779832 ext +47 jan.bjordal@uib.no

Locations
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Norway
Bergen Accident Emergency Hospital Recruiting
Bergen, Norway
Contact: Humaira Sæbø, M.Sc       Humaira.Sebo@uib.no   
Sponsors and Collaborators
University of Bergen
Norwegian Fund for Postgraduate Training in Physiotherapy
Investigators
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Study Director: Jan Magnus Bjordal, Professor University of Bergen

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Responsible Party: Humaira Sæbø, MS, University of Bergen
ClinicalTrials.gov Identifier: NCT02749929     History of Changes
Other Study ID Numbers: 569093
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
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:
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Colles' Fracture
Fractures, Bone
Wounds and Injuries
Fracture Dislocation
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Radius Fractures