Effectiveness of HILT in Shoulder Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis of the Shoulder
• Interventions: Device: HIRO® 3.0; Device: Sham laser

• Registration Number: NCT03385408
• Lead Sponsor: University of Rzeszow

Brief Summary

This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the treatment of shoulder osteoarthritis.

Detailed Description

Shoulder osteoarthritis (SO) is a musculoskeletal joint disease that affects the elderly. SO is characterized by degeneration of the articular cartilage in the involved joints and its underlying bone within a joint as well as bony overgrowth. It is one of the major causes of physical disability that has a social and public health impact due to pain, stiffness, joint instability, and muscle weakness.

The diagnosed patients with SO will be treated with HILT for a total of ten sessions during the entire duration of the treatment protocol. Parameters to be evaluated are: range of motion, pressure pain (algometer), pain perception (Visual Analog Scale (VAS), Modified Laitinen Pain Questionnaire), quality of life (WHOQoL-BREF) These parameters will be recorded before the first treatment (baseline), after completion of treatment, three and 12 months after completion treatment. A change in above parameters will be evaluated.

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-28
• Study Start: 2018-01-02
• Primary Completion: 2018-02-21
• Study Completion: 2019-08-21
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. painful osteoarthritis of the shoulder for at least 6 months
2. not engage in any other treatment during treatment period
3. pain ≥4 on the visual analog scale (VAS) in the previous 3 months

Exclusion Criteria

1. presence of any other musculoskeletal problems associated with the shoulder joint, such as fracture, tendon or ligament tears, meniscus injury, rheumatoid arthritis, or shoulder surgery
2. receiving physical therapy and/or intra-articular corticosteroid or hyaluronic acid injections during the last 6 months
3. absolute and relative contraindications of Laser Therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HILT group	HIRO® 3.0	High-intensity laser therapy application through HIRO 3.0 device
Placebo group	Sham laser	Sham high-intensity laser therapy application through HIRO 3.0 device

Primary Outcome Measures

Name	Time	Method
Change in the pain perception	at baseline, immediately after treatment completion, 3 and 12 months after treatment completion	Evolution of pain (Visual Analogic Scale and the Modified Laitinen Pain Questionnaire) between baseline, after the end of the protocol treatment, 3 and 12 months after the end of the protocol treatment

Secondary Outcome Measures

Name	Time	Method
Change in the quality of life	at baseline, immediately after treatment completion, 3 and 12 months after treatment completion	Comparison of the WHOQOL-BREF questionnaire mean between baseline, immediately after treatment the end of the protocol treatment, 3 and 12 months after the end of the protocol treatment. Quantitative evaluation of the primary outcome.
Change in the range of motion	at baseline, immediately after treatment completion, 3 and 12 months after treatment completion	Comparison of the range of motion between baseline, immediately after the end of the protocol treatment, 3 and 12 months after the end of the protocol treatment. Quantitative evaluation of the primary outcome.
Change in the pressure pain	at baseline, immediately after treatment completion, 3 and 12 months after treatment completion	Comparison of the pressure pain (algometer) between baseline, immediately after the end of the protocol treatment, 3 and 12 months after the end of the protocol treatment. Quantitative evaluation of the primary outcome.

Trial Locations

Locations (1)

University of Rzeszów; 🇵🇱 Rzeszów, Poland