Efficacy of High-intensity Laser in Jaccoud's Arthropathy in Systemic Lupus Erythematosus
Condition: Musculoskeletal Diseases; Skin Diseases
MeSH terms: Joint Diseases; Musculoskeletal Diseases; Lupus Erythematosus, Systemic; Skin Diseases
Study type: Interventional

Summary: 
      A randomized, controlled study with the pretest-posttest design was performed; 50 patients
      who were suffered from jaccoud's arthropathy and aged 30-50 years. Patients were randomly
      assigned into two groups: Group 1 (study group): received HILT, in addition to the routine
      physical therapy program. Group 2 (control group): received routine physical therapy program.
      All treatment interventions were applied at a frequency of three sessions per week for 8
      weeks. The participants were recruited from the air forces hospital at the period from
      December 2018 and October 2019.
    

Detailed description: 
      A sample of 55 female patients was recruited from the Kasr El-Ani hospital outpatient clinic
      to be treated in the outpatient clinic, Air forces hospital, Cairo. at the period from
      December 2018 and July 2019 with 50 of them completing the study. They were enrolled and
      assessed for their eligibility to participate in the study. The patients were randomly
      classified into 2 groups of equal number. Group 1 (Study group): received HILT, in addition
      to the routine physical therapy program. Group 2 (Control group): received routine physical
      therapy program. The patient's age ranged from 30 to 50 years. Elapsed time since the
      beginning of the disease was less than 1 year. All patients received the same medication.
      Patients were excluded if they had one or more of the following: positive rheumatic factor,
      circulatory disorders, neurological disease, diabetes, pregnant woman, communication problems
      or skin diseases.

      The participants were informed in details about the nature, purpose, and benefits of the
      study, they had complete right to refuse or withdraw from the study at any time, and the
      confidentiality of any obtained information.

      Interventions Patients indiscriminately assigned to study group (Group- 1):- 25 female
      Patients had been dealt with a received routine physical therapy program, in addition to
      HILT. Patients in the study group received pulsed Nd: YAG laser treatment, produced by a HIRO
      3 device (ASA Laser, Arcugnano, Italy). The apparatus provided pulsed emission (1064 nm),
      very high peak power (3 kW), a high level of fluency (energy density; 360-1780 mJ/cm2), a
      short duration (120-150 μs), a mean power of 10.5 W, a low frequency (10-40 Hz), a duty cycle
      of about 0.1%, a probe diameter of 0.5 cm, and a spot size of 0.2 cm2 [9]. Twenty four
      treatment sessions with pulsed Nd: YAG laser were applied to the subjects of the study group,
      three sessions per week, over 8 weeks in succession via HIRO® 3.0 device (ASAlaser,
      Arcugnano, Vicenza, Italy). The device gives pulsed emission (λ = 1064 nm), maximum power
      (3000 W), fluency range (360-1780 mJ/cm2), pulse duration (≤ 100 μs), frequency range (10-40
      Hz), maximum energy per pulse (350 mJ), mean power (10.5 W), and power cycle of ~0.1%. The
      device is equipped with a standard handpiece endowed with a fixed spacer and has a diameter
      of 0.5 cm and a spot size of 0.2 cm2. A pair of protective eye goggles were provided for the
      both the participant and the therapist. The participants were treated while assuming a
      sitting position, with their hand rested at the table. Every laser application comprised
      three phases: phase 1, where a fast scanning was applied transversely and longitudinally
      around the wrist and hand with three respective fluencies set at 510, 610, and 710 mJ/cm2 for
      a total of 300 J; phase 2, where a total of 10 fixed points around metacarpophalangeal joint
      and wrist joint were irradiated, in this phase, each point was radiated for 15 s, using a
      fluency of 710 mJ/cm2, 150 J/point, and a total of 150 J; and phase 3, where a scanning like
      that in phase 1 was applied, but at a much slower rate with a total energy of 300 J. The
      scanning energy density was 10 J/cm2 and the average irradiated area was 60 cm2. The control
      group (Group 2): 25 female Patients, in Group-B had been dealt with routine physical therapy
      program for 8 weeks, 3 sessions /week. Both groups received 24 sessions of treatment, 3 times
      per week for 8 weeks.
    

Intervention name(s): high-intensity laser Device.
Intervention type(s): Device
Intervention description(s): Twenty four treatment sessions with pulsed Nd: YAG laser were applied to the subjects of the study group, three sessions per week, over 8 weeks in succession via HIRO® 3.0 device (ASAlaser, Arcugnano, Vicenza, Italy). The device gives pulsed emission (λ = 1064 nm), maximum power (3000 W), fluency range (360-1780 mJ/cm2), pulse duration (≤ 100 μs), frequency range (10-40 Hz), maximum energy per pulse (350 mJ), mean power (10.5 W), and power cycle of ~0.1%.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients in the study group received pulsed Nd: YAG laser treatment, produced by a HIRO 3 device (ASA Laser, Arcugnano, Italy). The apparatus provided pulsed emission (1064 nm), very high peak power (3 kW), a high level of fluency (energy density; 360-1780 mJ/cm2), a short duration (120-150 μs), a mean power of 10.5 W, a low frequency (10-40 Hz), a duty cycle of about 0.1%, a probe diameter of 0.5 cm, and a spot size of 0.2 cm2 [9].
Masking: None (Open Label)
Primary purpose: Treatment