A Double-blind Placebo-controlled Study of Low-level Laser Therapy After Removal of Cast in Distal Radius Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Function and pain
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Low-Level Laser therapy
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.
干预措施: Low-Level Laser Therapy (Other)
Placebo Low-Level Laser therapy
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.
干预措施: Placebo Low Level Laser therapy (Other)
结局指标
主要结局
Function and pain
时间窗: 26 weeks
Function will be assessed using Patient Rating Wrist and Hand Evaluation (PRWHE), and questions about night pain/pain killers
次要结局
- Swelling will be assessed using measurement tape(26 weeks)
- Pain assessed using Pressure Algometer(26 weeks)
- Strength will be assessed using dynamometer(26 weeks)
- Active range of motion will be assessed using goniometer(26 weeks)