Efficacy of High-intensity Laser in Jaccoud's Arthropathy in Systemic Lupus Erythematosus

Musculoskeletal Diseases Clinical Trial

Official title:

Efficacy of High-intensity Laser in Jaccoud's Arthropathy in Systemic Lupus Erythematosus: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04244539
• Other study ID #: P.T.REC/012/002616
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: January 2020
• Source: Jouf University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients were excluded if they had one or more of the following:

• Positive rheumatic factor,

• Circulatory disorders,

• Neurological disease,

• Diabetes,

• Pregnant woman,

• Communication problems

• Skin diseases.

Related Conditions & MeSH terms

• Joint Diseases
• Lupus Erythematosus, Systemic
• Musculoskeletal Diseases
• Skin Diseases

Intervention

Device:
• high-intensity laser Device.
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 (? = 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%.

Locations

Country	Name	City	State
Egypt	Faculty of physical therapy, Cairo University.	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
Jouf University	Cairo University, Nabil Mahmoud Abdel-Aal

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hand grip strength	Handheld Jamar dynamometer device 12-0600 was used to measure handgrip strength. The readout of dynamometer dial is represented in pounds and in kilograms. It is graded from zero to two hundred pounds and from zero to ninety kilograms [14]. Grip measurement was performed with the elbow at about 90° according to the American Society of Hand Therapists (ASHT) recommendations .The patients were instructed to assume the sitting position while the affected limb was placed in shoulder adduction and internal rotation, elbow flexion, forearm in mid-position and wrist in the neutral position. The patients were instructed to squeeze the dynamometer as much as possible. Three consecutive measurements were performed with a 2 minutes inter-measurement interval.	after 8 weeks of intervention.
Secondary	Joint counts for tenderness and swelling	the sum of the number of affected joints	after 8 weeks of intervention
Secondary	Pain Intensity: visual analogue scale (VAS)	A visual analogue scale (VAS) was used for the assessment of joint pain [17]. It is an ordinal scale, using a 100-mm line divided into 10 equal sections, with 0 representing "no pain" and 10 representing "unbearable pain." Each participant was asked to indicate on the scale the level of pain in the hand and wrist joint at the baseline and post-treatment after the end of sessions.	after 8 weeks of treatment.