Effectiveness of HILT in Shoulder Osteoarthritis

Osteoarthritis of the Shoulder Clinical Trial

Official title:

Effectiveness of High-intensity Laser Therapy in Shoulder Osteoarthritis; a Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385408
• Other study ID #: HILT-osteoarthritis
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: August 21, 2019

Study information

• Verified date: February 2023
• Source: University of Rzeszow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 21, 2019
• Est. primary completion date: February 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Shoulder

Intervention

Device:
• HIRO® 3.0
Patients will receive pulsed Nd:YAG (yttrium aluminum garnet) laser, produced by HIRO 3.0 device (ASA, Vicenza, Italy). The total energy deliver to the patient during one session will be 3.000 J through three phases of treatment. HILT will be applied for a total of 4 weeks (three sessions/week).
• Sham laser
For sham laser, the patient will attended the physical therapy clinic three times a week for 4 weeks and receive sham laser. It is applies the same time than experimental one but with 0 W.

Locations

Country	Name	City	State
Poland	University of Rzeszów	Rzeszów

Sponsors (1)

Lead Sponsor	Collaborator
University of Rzeszow

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the pain perception	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	at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
Secondary	Change in the quality of life	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.	at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
Secondary	Change in the range of motion	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.	at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
Secondary	Change in the pressure pain	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.	at baseline, immediately after treatment completion, 3 and 12 months after treatment completion