Comparison of the effects of high-intensity laser therapy versus low-level laser therapy on pain, function and range of motion in patients with sub-acute ankle sprain: A randomized controlled trial

This study aims to compare the effects of high-intensity laser therapy, low-level laser therapy and conventional therapy on pain, function and range of motion in the patients with sub-acute ankle sprain.

Thirty six patients with ankle sprain are divided into three groups (high intensity and low- level laser and control) by simple randomization using a sealed envelope. The study is double blinded and the third phase.

An ankle sprain is where one or more of the ligaments of the ankle are partially or completely torn. High Intensity Laser and Low-level laser are effective in reducing pain and improving function. But there is a lack of evidence on effectiveness of these kind of lasers in ankle sprain. This study will be double blinded (patients and assessor) and will be performed in the physiotherapy clinic of the School of Rehabilitation of Tehran University of Medical Sciences-Iran.

Inclusion criteria: Age of 18 to 30 years, grade I or II ankle sprain in the prior one to five weeks, pain intensity will be more than 4 at Numeric Pain Rating Scale, 4 common clinical tests; palpatory tenderness, anterior drawer test, talar tilt test, and squeeze test will be used to detect the ankle sprain and to exclude other ankle injuries. Exclusion criteria: Ankle sprain Grade III, history of recent surgery, trauma and fracture, congenital and acquired deformities of lower limbs, and history of Cancer or tumors.

Both intervention groups will receive routine treatments including ultrasound, supervised and home exercises. One of the intervention groups will receive the high- intensity laser and the other, the low- level laser. The control group will just receive the routine treatments and placebo laser.

The Numeric Pain Rating Scale, Foot and Ankle Ability Measure, Range of Motion

After the initial evaluation, the patients are randomly placed in one of the three intervention 1, intervention 2 and control groups (randomization method: block of six, unit: cluster). The randomization process will be done by an independent person and each of the numbers assigned to the participants through the software (randomization tool: Random Allocation software with a block of six and equal allocation ratio for three groups), they are placed inside a sealed envelope and the patients receive this envelope from the clinic secretary who is not aware of the evaluation processes and etc.

As mentioned above, the study will be double-blinded. In this way, the participants do not know in which group they are. Participants only know that laser are used for them and have no knowledge of the type of laser (high intensity, low- level, and placebo laser in the control group). The data analyzer is also unaware of which study group the data belongs to. But the therapist, who is the one applying the different lasers, assessing the outcome measures, knows the participants' groups.

All data is potentially shareable after unidentified individuals.

Access period starts 3 months after the articles are published

For researchers working in academic, scientific and hospital institutions

Researchers working in the field of musculoskeletal physiotherapy and electrotherapy.

Applicants for documentation can contact Dr. Sara Fereydounnia via email. S-fereydounnia@sina.tums.ac.ir

Once they have the necessary criteria, the information will be provided to them within a month.