Low-level Laser Therapy in Wrist Fractures

NCT02749929 | Completed

• 1 other identifier: 569093
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colles' Fracture

Keywords

Distal radius fracture, Low Level Laser Therapy

Outcome Measures

Primary Outcomes (1)

• Function and pain

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

  26 weeks

Secondary Outcomes (4)

• Pain by pressure

  26 weeks

• Swelling

  26 weeks

• Active range of motion

  26 weeks

• Grip- and pinch Strength

  26 weeks

Study Arms (2)

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.

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.

Other: Placebo Low Level Laser Therapy

Interventions

Low level laser therapy OTHER

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

Low-Level Laser therapy

Placebo Low Level Laser Therapy OTHER

The placebo laser is an identical device to the active laser, made by Irradia Midlaser

Placebo Low-Level Laser therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• + 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 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

Sponsors & Collaborators

• University of Bergen: lead
• Norwegian Fund for Postgraduate Training in Physiotherapy: collaborator

Study Sites (1)

Bergen Accident Emergency Hospital

Bergen, Norway

Location

MeSH Terms

Conditions

Colles' Fracture; Wrist Fractures

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Radius Fractures; Fractures, Bone; Wrist Injuries; Arm Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

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, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MS

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: April 25, 2016
• Study Start: April 1, 2016
• Primary Completion: November 30, 2020
• Study Completion: April 27, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)