|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
30 May 2022 |
|
Main ID: |
NCT03014024 |
|
Date of registration:
|
06/01/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Low-level Laser Therapy in Distal Radius Fractures
|
|
Scientific title:
|
A Double-blind Placebo-controlled Study of Low-level Laser Therapy After Removal of Cast in Distal Radius Fractures |
|
Date of first enrolment:
|
December 2016 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03014024 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Norway
| | | | | | | |
|
Contacts
|
|
Name:
|
Jan Magnus Bjordal, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Bergen |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Colles' Fracture
|
|
Intervention(s)
|
|
Other: Low-Level Laser Therapy
|
|
Other: Placebo Low Level Laser therapy
|
|
Primary Outcome(s)
|
|
Function and pain
[Time Frame: 26 weeks]
|
|
Secondary Outcome(s)
|
|
Active range of motion will be assessed using goniometer
[Time Frame: 26 weeks]
|
|
Strength will be assessed using dynamometer
[Time Frame: 26 weeks]
|
|
Swelling will be assessed using measurement tape
[Time Frame: 26 weeks]
|
|
Pain assessed using Pressure Algometer
[Time Frame: 26 weeks]
|
|
Secondary ID(s)
|
|
2016/1633
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|