Efficacy of Pulsed High Intensity Laser Therapy in Psoriatic Hand Arthritis

NCT06665282 | Completed

• 1 other identifier: Mahmoud-004436
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

High Intensity Laser Therapy; Psoriasis; Hand

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• assessment of Joint counts for tenderness

  at baseline and after 2 months

• assessment of Joint swelling count

  at baseline and after 2 months

• assessment of pain intensity using visual analogue scale

  at baseline and after 2 months

Study Arms (2)

Pulsed high intensity level laser therapy group

EXPERIMENTAL

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; Other: Routine physical therapy program

Shame pulsed high intensity laser level therapy

ACTIVE COMPARATOR

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

Device: sham pulsed high intensity laser therapy; Other: Routine physical therapy program

Interventions

Pulsed high intensity laser therapy 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.

Pulsed high intensity level laser therapy group

sham pulsed high intensity laser therapy 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

Shame pulsed high intensity laser level therapy

Routine physical therapy program 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

Pulsed high intensity level laser therapy group; Shame pulsed high intensity laser level therapy

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Giza, Egypt

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: August 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

EG (1)