Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain

ConditionsAnkle Sprain 1St Degree Ankle Sprain 2Nd Degree Acute Pain

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorDJO UK Ltd

About this trial

DJO UK Ltd (ENOVIS) is conducting this study to assess the effectiveness of LightForce® Therapy Lasers on pain reduction in subjects with ankle soft tissue trauma and/or sport injury. In detail this study will assess superiority of LightForce® Therapy Lasers combined with standard of care, represented by RICE and physiotherapy/exercise program, compared to sham laser combined with standard of care (RICE and physiotherapy/exercise program) on pain reduction in subjects with acute grade I - II lateral ankle sprain. In addition, this study allows to collect post market clinical data on the safety and performance of LightForce® Therapy Lasers, when used, following the normal clinical practice, in accordance with its approved and CE marked intended use.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient male or female with age ≥18 years old

Patient with diagnosis of LAS (as confirmed by physical examination) to be treated by LightForce® Therapy Lasers according to its indications.

Patient suffering from LAS pain for no more than 72 hours prior to enrollment

Pain (either persistent or during activities) score reported by the subject at baseline ≥ 40 mm measured on VAS

Disqualifiers

Patient with musculoskeletal pathological conditions not to be treated with/contraindication to the use of LightForce® Therapy Lasers according to its intended use and indications

Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids

Patients who have been administered with corticosteroids after injury

Pregnant females or females of childbearing potentially planning to become pregnant during the study participation

Trial design

Design model

Parallel

Treatments tested in this trial

Sham Laser therapy
Device
sham laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week, for the first 2 weeks, and then a minimum of 2 sessions per week for the following 2 weeks.
Laser therapy
Device
laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week, for the first 2 weeks, and then a minimum of 2 sessions per week for the following 2 weeks.
RICE and physiotherapy/exercise protocol
Other intervention
RICE plus physiotherapy/exercise protocol represents the standard of care (SOC) and the program includes: for the first 2 weeks RICE protocol performed daily at home by the patient, for the following 4 weeks a physiotherapy/exercise protocol will be performed at site with 2 sessions per week.

Treatment groups

108 Participants

are divided into 2 treatment groups

Group A: Sham Laser treatment - Arm 1Sham comparator 2 interventions

Group B: Laser Treatment - Arm 2Active comparator 2 interventions

Trial outcomes

Primary outcomes

Pain change

Pain reduction measured with Visual Analog Scale (VAS) (in a scale 0-100 mm, where 0 is no pain and 100 is the worst possible pain) after 4 weeks of treatment compared to pre-treatment (baseline) VAS

Time frame

2 weeks after treatment start

Secondary outcomes

Safety - adverse event rate

Proportion of patient experiencing an adverse event associated with device use

Time frame

through study completion, an average of 12 weeks

Other outcomes

Pain change

Pain measured with Visual Analog Scale (VAS) (in a scale 0-100 mm, where 0 is no pain and 100 is the worst possible pain) at 1,3,4, 6 and 12 weeks after treatment start to assess short-term and long-term pain management compared to baseline

Time frame

1,3,4, 6 and 12 weeks after treatment start

Ankle pain and Disability

Ankle pain and disability measured with the Foot and Ankle Disability Index (FADI) questionnaire (the score output is given as a percentace) and the highest the percentage the better is the clinical outome, the lowest the percentage the worse is the clinical outcome; performed at 1, 2, 3, 4, 6 and at 12 weeks after treatment start compared to baseline.

Time frame

1, 2, 3, 4, 6 and at 12 weeks after treatment start

Patient overall status change

Patient ratings of overall improvement, assessed by QoL (SF-12): The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 uses 12 items and scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. SF-12 will be assessed at 2, 4, 6 weeks and at 12 weeks and compared to baseline

Time frame

2, 4, 6 ans 12 weeks after treatment start

Range of motion (ROM) of the ankle

Range of motion for the ankle (flex-extension) measured by a universal goniometer at 1,2, 4, 6 and 12 weeks after treatment start compared to baseline

Time frame

1, 2, 3, 4, 6 and 12 weeks after treatment start

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

DJO UK Ltd

Lead sponsor

Donawa Lifescience Consulting SRL

Collaborator

Source ClinicalTrials.gov

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