Effectiveness of HILT in Shoulder Osteoarthritis

• ClinicalTrials.gov Identifier: NCT03385408
• Recruitment Status: Completed
• First Posted: December 28, 2017
• Last Update Posted: January 28, 2022
• Sponsor: University of Rzeszow
• Information provided by (Responsible Party): Justyna Wyszyńska, University of Rzeszow

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Osteoarthritis of the Shoulder	Device: HIRO® 3.0; Device: Sham laser	Not Applicable

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 6 months after completion treatment. A change in above parameters will be evaluated.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effectiveness of High-intensity Laser Therapy in Shoulder Osteoarthritis; a Prospective, Randomized, Controlled Study
• Actual Study Start Date: January 2, 2018
• Actual Primary Completion Date: February 21, 2018
• Actual Study Completion Date: August 21, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: HILT group; High-intensity laser therapy application through HIRO 3.0 device	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 Comparator: Placebo group; Sham high-intensity laser therapy application through HIRO 3.0 device	Device: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in the pain perception [ Time Frame: 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 :

1. Change in the quality of life [ Time Frame: 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.
2. Change in the range of motion [ Time Frame: 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.
3. Change in the pressure pain [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Poland

University of Rzeszów

Rzeszów, Poland, 35-205

Sponsors and Collaborators

University of Rzeszow

Investigators

• Principal Investigator: Justyna Wyszyńska, PhD; University of Rzeszów

More Information

• Responsible Party: Justyna Wyszyńska, Principal Investigator, University of Rzeszow
• ClinicalTrials.gov Identifier: NCT03385408
• Other Study ID Numbers: HILT-osteoarthritis
• First Posted: December 28, 2017
• Last Update Posted: January 28, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases