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Musculoskeletal DiseasesNCT04244539

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

A study testing high-intensity laser Device. in people with Musculoskeletal Diseases and Skin Diseases, run by Jouf University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 to 50 years, women only
Conditions the study is for
Musculoskeletal Diseases, Skin Diseases
What is being tested?
high-intensity laser Device.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Dec 2018to 30 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of physical therapy, Cairo University.

    Cairo, 0025

Other trials in Egypt

About this study

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

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.

Read the 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.

Being tested
high-intensity laser Device.
Medical subject headings
Musculoskeletal Diseases, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high-intensity laser Device.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 (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%.

Study groups in NCT04244539
Study groupRoleWhat they receive
Experimental groupExperimentala 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),
Receives: Device: high-intensity laser Device.
Control groupActive comparatorThe control group received traditional physical therapy program in the form of strengthening exercise, stretching , and range of motion exercise.for the affected digits and wrists. for one hour, three sessions per week for 8 weeks.
Receives: Device: high-intensity laser Device.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: after 8 weeks of intervention.

Secondary outcomes (2)
  1. Joint counts for tenderness and swelling

    the sum of the number of affected joints

    Measured: after 8 weeks of intervention

  2. 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.

    Measured: after 8 weeks of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2020
  2. Study start1 Dec 2018
  3. Primary completion30 Oct 2019
  4. Study completion30 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04244539
Sponsor's protocol ID
P.T.REC/012/002616
Status last verified
Jan 2020
First submitted
22 Jan 2020
Last updated
28 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: study protocol and informed Consent form will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing high-intensity laser Device. in people with Musculoskeletal Diseases and Skin Diseases, run by Jouf University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hand grip strength (time frame: after 8 weeks of intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.

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