Effectiveness of HILT in Shoulder Osteoarthritis

NCT03385408 | Completed

• 1 other identifier: HILT-osteoarthritis
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis of the Shoulder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in the quality of life

  at baseline, immediately after treatment completion, 3 and 12 months after treatment completion

• Change in the range of motion

  at baseline, immediately after treatment completion, 3 and 12 months after treatment completion

• Change in the pressure pain

  at baseline, immediately after treatment completion, 3 and 12 months after treatment completion

Study Arms (2)

HILT group

EXPERIMENTAL

High-intensity laser therapy application through HIRO 3.0 device

Device: HIRO® 3.0

Placebo group

SHAM COMPARATOR

Sham high-intensity laser therapy application through HIRO 3.0 device

Device: Sham laser

Interventions

HIRO® 3.0 DEVICE

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).

HILT group

Sham laser DEVICE

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• receiving physical therapy and/or intra-articular corticosteroid or hyaluronic acid injections during the last 6 months
• absolute and relative contraindications of Laser Therapy

Sponsors & Collaborators

• University of Rzeszow: lead

Study Sites (1)

University of Rzeszów

Rzeszów, 35-205, Poland

Location

Study Officials

• Justyna Wyszyńska, PhD

  University of Rzeszow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 28, 2017
• Study Start: January 2, 2018
• Primary Completion: February 21, 2018
• Study Completion: August 21, 2019
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)