Efficacy of Pulsed High Intensity Laser Therapy in Psoriatic Hand Arthritis

Efficacy of Pulsed High Intensity Laser Therapy in Treatment of Psoriatic Hand Arthritis

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Hand; High Intensity Laser Therapy
• Intervention / Treatment: Device: Pulsed high intensity laser therapy; Other: Routine physical therapy program; Device: sham pulsed high intensity laser therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • out-patient clinic, faculty of physical therapy, Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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.; Other: 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
Active Comparator: 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	Other: 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of change of Hand Grip Strength using manual dynamometer	The Handheld Jamar dynamometer device 12-0600 will be used to measure hand grip strength, with a readout in pounds and kilograms. The strength will be measured with the elbow at 90° according to the American Society of Hand Therapists' recommendations. Patients will be instructed to sit while the affected limb is placed in shoulder adduction, internal rotation, elbow flexion, forearm mid position, and wrist neutral position. Three consecutive measurements will be performed with a 2-minute interval, and the mean strength value of the three trials will be considered as the hand grip measure.	at baseline and after 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of Joint counts for tenderness	Joint counts for tenderness was the sum of the number of the affected joints	at baseline and after 2 months
assessment of Joint swelling count	Joint swelling count is the sum of the swollen joints at the dominant hand before and after the treatment	at baseline and after 2 months
assessment of pain intensity using visual analogue scale	The Visual Analog Scale was used to measure pain intensity, with a 100mm horizontal line starting with no pain and ending with worse pain. Patients marked their pain intensity points on the scale, and the researcher measured the distance between the "no pain" mark and the patient's mark, providing a range of scores from 0 to 100mm.	at baseline and after 2 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Arthritis; Psoriasis
• Other Study ID Numbers: Mahmoud-004436

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No