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Completed

NCT Number: NCT03385408

Effectiveness of HILT in Shoulder Osteoarthritis

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rzeszów

Rzeszów, 35-205, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Rzeszow

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Dec 28, 2017
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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