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Effectiveness of HILT in Shoulder Osteoarthritis

U

University of Rzeszow

Status

Completed

Conditions

Osteoarthritis of the Shoulder

Treatments

Device: Sham laser
Device: HIRO® 3.0

Study type

Interventional

Funder types

Other

Identifiers

NCT03385408
HILT-osteoarthritis

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

60 participants in 2 patient groups

HILT group
Experimental group
Description:
High-intensity laser therapy application through HIRO 3.0 device
Treatment:
Device: HIRO® 3.0
Placebo group
Sham Comparator group
Description:
Sham high-intensity laser therapy application through HIRO 3.0 device
Treatment:
Device: Sham laser

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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