Efficacy of Pulsed High Intensity Laser Therapy in Psoriatic Hand Arthritis

NCT ID: NCT06665282

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-07-01

Brief Summary

The purpose of the study was to evaluate the therapeutic efficacy of pulsed high intensity level laser therapy in improving symptoms of psoriatic hand arthritis.

Detailed Description

Psoriatic arthritis is a chronic, inflammatory joint disease affecting 20%-30% of patients with psoriasis. It affects peripheral joints and axial skeleton, causing pain, stiffness, swelling, and joint destruction. High-intensity laser therapy can control inflammation and improve pain relief, range of motion, and functional improvement. This study aims to examine High-intensity laser therapy efficacy in managing Psoriatic arthritis, aiming to provide a safe, effective, and noninvasive treatment method.

Conditions

High Intensity Laser Therapy; Psoriasis; Hand

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pulsed high intensity level laser therapy group

This group includes 38 patients who will receive pulsed high intensity level laser therapy 3 sessions per week over 8 successive weeks in addition to routine physical therapy in the form of hot therapy, stretching and strengthening exercises

Group Type: EXPERIMENTAL

Pulsed high intensity laser therapy

Intervention Type: DEVICE

The study employs a BTL-6000 high-intensity laser therapy (12 W) to apply high intensity laser therapy to deep tissues. high intensity laser therapy therapy uses powerful beams (>500 mw) to penetrate deeper, delivering high multi-directional energy in a short time. Pulsed laser therapy, a form of high intensity laser therapy therapy, enhances cell metabolism without disrupting it.

High-intensity laser therapy is a safe treatment method consisting of three phases. The first phase involves fast scanning around the wrist, hand, and fingers, with fluencies set at 510, 610, and 710mJ/cm2. The second phase involves holding the handpiece vertically to 90° on 10 fixed points around the metacarpophalangeal and interphalangeal joints, each radiated for 15 seconds, and a total dose of 1500 J. The third phase is the same but at a slower rate, with a total energy of 300 J.

Routine physical therapy program

Intervention Type: OTHER

All patients of the study and control groups will receive the same routine physical therapy program for 30minutes and three times per week for successive eight weeks in the form of hot therapy, stretching and strengthening exercises. Hot therapy, in the form of warm baths for 10minutes, is applied before stretching exercises on the wrist joint and fingers to relieve joint pain and increase the range of motion. Strengthening exercises are in the form of isometric exercise for hand muscles and fingers to maintain muscles strength and joints flexibility

Shame pulsed high intensity laser level therapy

This group includes 38 patients who will receive shame pulsed high intensity laser level therapy 3 sessions per week over 8 successive weeks in addition to routine physical therapy in the form of hot therapy, stretching and strengthening exercises

Group Type: ACTIVE_COMPARATOR

sham pulsed high intensity laser therapy

Intervention Type: DEVICE

Patients in the control group will receive sham high-intensity laser therapy, where all parameters will be set up without switching on the start button and high intensity laser therapy machine is switched on with a visible light beam only

Routine physical therapy program

Intervention Type: OTHER

All patients of the study and control groups will receive the same routine physical therapy program for 30minutes and three times per week for successive eight weeks in the form of hot therapy, stretching and strengthening exercises. Hot therapy, in the form of warm baths for 10minutes, is applied before stretching exercises on the wrist joint and fingers to relieve joint pain and increase the range of motion. Strengthening exercises are in the form of isometric exercise for hand muscles and fingers to maintain muscles strength and joints flexibility

Interventions

Pulsed high intensity laser therapy

The study employs a BTL-6000 high-intensity laser therapy (12 W) to apply high intensity laser therapy to deep tissues. high intensity laser therapy therapy uses powerful beams (>500 mw) to penetrate deeper, delivering high multi-directional energy in a short time. Pulsed laser therapy, a form of high intensity laser therapy therapy, enhances cell metabolism without disrupting it.

High-intensity laser therapy is a safe treatment method consisting of three phases. The first phase involves fast scanning around the wrist, hand, and fingers, with fluencies set at 510, 610, and 710mJ/cm2. The second phase involves holding the handpiece vertically to 90° on 10 fixed points around the metacarpophalangeal and interphalangeal joints, each radiated for 15 seconds, and a total dose of 1500 J. The third phase is the same but at a slower rate, with a total energy of 300 J.

Intervention Type: DEVICE

sham pulsed high intensity laser therapy

Patients in the control group will receive sham high-intensity laser therapy, where all parameters will be set up without switching on the start button and high intensity laser therapy machine is switched on with a visible light beam only

Intervention Type: DEVICE

Routine physical therapy program

All patients of the study and control groups will receive the same routine physical therapy program for 30minutes and three times per week for successive eight weeks in the form of hot therapy, stretching and strengthening exercises. Hot therapy, in the form of warm baths for 10minutes, is applied before stretching exercises on the wrist joint and fingers to relieve joint pain and increase the range of motion. Strengthening exercises are in the form of isometric exercise for hand muscles and fingers to maintain muscles strength and joints flexibility

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Both sexes of patients their age range between 30-50 years.
• Bilateral PsA following psoriasis
• All participants who are diagnosed with PsA, and experience clinical symptoms such as pain, swelling, tenderness and stiffness less than 1 year from the beginning of disease.
• All patients enrolled to the study will have their informed consent.

Exclusion Criteria

• Positive rheumatic factor
• Circulatory disorders
• Diabetes
• Pregnant woman
• Skin diseases like urticaria.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Shawky Helmy Abdelhamid

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

out-patient clinic, faculty of physical therapy, Cairo university

Giza, , Egypt

Countries

Egypt

Other Identifiers

Mahmoud-004436

Identifier Type: -

Identifier Source: org_study_id