Performance and Safety of LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Reduction

ConditionsShoulder Pain Shoulder Impingement Syndrome Rotator Cuff Tendinitis

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 shoulder soft tissue inflammation. In detail this study will assess superiority of LightForce® Therapy Lasers combined with standard of care, represented by physiotherapy/exercise program compared to sham laser combined with standard of care (physiotherapy/exercise program) on pain reduction in subjects with shoulder soft tissue inflammation due to Impingement (Subacromial impingement syndrome (SAIS)) or Rotator Cuff Tendinopathy (RCT),. 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 shoulder soft tissue inflammation due to SAIS/RCT (as confirmed by physical examination and/or imaging) to be treated by LightForce® Therapy Lasers according to its indications.

Patient suffering from shoulder soft tissue inflammation due to SAIS/RCT pain for more than 3 months 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 are administered with corticosteroids, should discontinue the treatment at least 2 weeks prior to study treatment start

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.
Laser therapy
Device
laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week.
physiotherapy/exercise protocol
Other intervention
physiotherapy/exercise protocol represents the standard of care (SOC) and the program includes Codman's pendulum exercise, range of motion (ROM) exercises, stretching and isometric strengthening exercises, for 4 consecutive weeks with a minimum of 3 sessions per week.

Treatment groups

130 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

4 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 21 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 1,2,3,6, 9 and 12 weeks after treatment start to assess short-term and long-term pain management compared to baseline

Time frame

1,2,3,6, 9 and 12 weeks

Shoulder pain and disability

Shoulder pain and disability measured with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire (the score output is given as a percentace -from 0% to 100%- and the lower the percentage the better is the clinical outome, the higher the percentage the worse is the clinical outcome) performed at 2, 4, 6 and at 12 weeks after treatment start compared to baseline.

Time frame

2, 4, 6 and at 12 weeks

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) for shoulder

Range of motion for shoulder both passive and active, pain free and at maximum ROM, in all the planes of motion, measured by a universal goniometer at2, 4, 6 ans 12 weeks after treatment start compared to baseline

Time frame

2, 4, 6 ans 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

Collaborator

Source ClinicalTrials.gov

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