Colles' FractureNCT03014024
Low-level Laser Therapy in Distal Radius Fractures
A study testing Low-Level Laser Therapy in people with Colles' Fracture, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colles' Fracture
- What is being tested?
- Low-Level Laser Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Placebo-controlled Study of Low-level Laser Therapy After Removal of Cast in Distal Radius Fractures
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.
Read the 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).
- Conditions
- Colles' Fracture
- Being tested
- Low-Level Laser Therapy, Placebo Low Level Laser therapy
- Keywords
- Distal Radius Fracture, Low Level Laser Therapy
- Medical subject headings
- Colles' Fracture, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser TherapyOther
The laser is an infrared (invisible) 60 mW 904 nm, made by Irradia Midlaser
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo Low Level Laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function and pain
Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE), and questions about night pain/pain killers
Measured: 26 weeks
Secondary outcomes (4)
Pain assessed using Pressure Algometer
Pressure Algometer
Measured: 26 weeks
Swelling will be assessed using measurement tape
Swelling will be assessed using measurement tape
Measured: 26 weeks
Active range of motion will be assessed using goniometer
Active range of motion will be assessed using goniometer
Measured: 26 weeks
Strength will be assessed using dynamometer
Strength will be assessed using dynamometer
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionJun 2020
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colles' FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humaira Sæbø, University of Bergen
- Investigators
- Jan Magnus Bjordal, Professor, Study director, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014024
- Sponsor's protocol ID
- 2016/1633
- Status last verified
- May 2022
- First submitted
- 6 Jan 2017
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35030040
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Placebo-controlled Study of Low-level Laser Therapy After Removal of Cast in Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT03014024
- Acronym / sponsor ID
- 2016/1633
- Conditions
- Colles' Fracture
- Keywords
- Distal Radius Fracture, Low Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jun 2020 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Level Laser therapy | Experimental | Other: Low-Level Laser TherapyAfter 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. |
| Placebo Low-Level Laser therapy | Placebo comparator | Other: Placebo Low Level Laser therapyAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Level Laser TherapyThe laser is an infrared (invisible) 60 mW 904 nm, made by Irradia Midlaser | Other | Low-Level Laser therapy |
| Placebo Low Level Laser therapyThis i laser is not giving any irradiation, but is identical to the infrared (invisible) 60 mW 904 nm Irradia Midlaser, made by Irradia. | Other | Placebo Low-Level Laser therapy |
Primary outcome
Function and pain
Time frame: 26 weeks
Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE), and questions about night pain/pain killers
4 secondary outcomes
Pain assessed using Pressure Algometer
Time frame: 26 weeks
Swelling will be assessed using measurement tape
Time frame: 26 weeks
Active range of motion will be assessed using goniometer
Time frame: 26 weeks
Strength will be assessed using dynamometer
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 35030040Saebo 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.
- Individual participant dataSharing planned: No
Related trials for Colles' Fracture
Active, not recruitingPhase 4
Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Distal Radius Fractures, Fracture Dislocation
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Recruiting
Comparative Study Between Cannulated Screws and K-wires in the Fixation of Distal Radius Fractures
Distal Radius Fractures
Not yet recruiting
Comparison of Functional Outcomes of Closed Reduction With Cast Versus Closed Reduction With K-Wire Fixation in Colles' Fracture
Colles' Fracture
Recruiting
Comparison of Kaltenborn Mobilization and Mobilization With Movement (MWM) in Wrist Hypomobility After Colle's Fracture
Colles Fracture, Hypomobility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Magnus Bjordal, Professor study director
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy in people with Colles' Fracture, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Function and pain (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03014024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.