Colles' FractureNCT02749929
Low-level Laser Therapy in Wrist 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
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. 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
- 53 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2016to 27 Apr 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 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
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 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
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 in Wrist Fractures
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.
Read the 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.
- 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 Irradia Midlaser
Placebo Low Level Laser TherapyOther
The placebo laser is an identical device to the active laser, made by Irradia Midlaser
| Study group | Role | What they receive |
|---|---|---|
| Low-Level Laser therapy | Experimental | 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. Receives: Other: Low level laser therapy |
| Placebo Low-Level Laser therapy | Placebo comparator | 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. 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 and will be assessed using Patient Rating Wrist and Hand Evaluation a (PRWHE), and questions about night pain/pain killers
Measured: 26 weeks
Secondary outcomes (4)
Pain by pressure
Pain Pressure Threshold over distal radius will be assessed using Pressure Algometry
Measured: 26 weeks
Swelling
Swelling will be assessed using measurement tape
Measured: 26 weeks
Active range of motion
Active range of motion will be assessed using goniometer
Measured: 26 weeks
Grip- and pinch Strength
Strength will be assessed using handheld 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 posted25 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion30 Nov 2020
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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, Care provider, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- 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
- NCT02749929
- Sponsor's protocol ID
- 569093
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2016
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. 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 in Wrist Fractures
- ClinicalTrials.gov ID
- NCT02749929
- Acronym / sponsor ID
- 569093
- Conditions
- Colles' Fracture
- Keywords
- Distal radius fracture, Low Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- Apr 2016
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 25 Apr 2016 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Level Laser therapy | Experimental | Other: Low level laser therapyAfter 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. |
| Placebo Low-Level Laser therapy | Placebo comparator | Other: Placebo Low Level Laser TherapyAfter 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. |
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 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
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 have a peripheral nerve 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 Irradia Midlaser | Other | Low-Level Laser therapy |
| Placebo Low Level Laser TherapyThe placebo laser is an identical device to the active laser, made by Irradia Midlaser | Other | Placebo Low-Level Laser therapy |
Primary outcome
Function and pain
Time frame: 26 weeks
Function and will be assessed using Patient Rating Wrist and Hand Evaluation a (PRWHE), and questions about night pain/pain killers
4 secondary outcomes
Pain by pressure
Time frame: 26 weeks
Swelling
Time frame: 26 weeks
Active range of motion
Time frame: 26 weeks
Grip- and pinch Strength
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 30 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Colles' Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, 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
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 30 Apr 2021. 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?
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 30 Apr 2021.