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Effectiveness of HILT in Shoulder Osteoarthritis

Primary Purpose

Osteoarthritis of the Shoulder

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
HIRO® 3.0
Sham laser
Sponsored by
University of Rzeszow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Shoulder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rzeszów

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

HILT group

Placebo group

Arm Description

High-intensity laser therapy application through HIRO 3.0 device

Sham high-intensity laser therapy application through HIRO 3.0 device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
December 20, 2017
Last Updated
February 18, 2023
Sponsor
University of Rzeszow
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1. Study Identification

Unique Protocol Identification Number
NCT03385408
Brief Title
Effectiveness of HILT in Shoulder Osteoarthritis
Official Title
Effectiveness of High-intensity Laser Therapy in Shoulder Osteoarthritis; a Prospective, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
February 21, 2018 (Actual)
Study Completion Date
August 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rzeszow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HILT group
Arm Type
Experimental
Arm Description
High-intensity laser therapy application through HIRO 3.0 device
Arm Title
Placebo group
Arm Type
Sham Comparator
Arm Description
Sham high-intensity laser therapy application through HIRO 3.0 device
Intervention Type
Device
Intervention Name(s)
HIRO® 3.0
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Sham laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the pain perception
Description
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
Time Frame
at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
Secondary Outcome Measure Information:
Title
Change in the quality of life
Description
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.
Time Frame
at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
Title
Change in the range of motion
Description
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.
Time Frame
at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
Title
Change in the pressure pain
Description
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.
Time Frame
at baseline, immediately after treatment completion, 3 and 12 months after treatment completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justyna Wyszyńska, PhD
Organizational Affiliation
University of Rzeszów
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rzeszów
City
Rzeszów
ZIP/Postal Code
35-205
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of HILT in Shoulder Osteoarthritis

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