Anti Inflammatory Diet With Physical Therapy on Psoriasis

This is a prospective, assessor-blinded, three-arm randomized controlled trial designed to evaluate the efficacy of a gluten-free, low-histamine anti-inflammatory diet, with or without a structured physical therapy program, on disease severity and inflammatory biomarkers in children with psoriasis. The study will be conducted over 12 weeks at the outpatient clinics of Cairo University's Faculty of Physical Therapy and Department of Dermatology.

Study Population:

Sixty (60) children, aged 6 to 17 years, with a confirmed diagnosis of plaque psoriasis (P-PASI ≤ 20) for at least six months.

Study Design:

Participants will be randomly assigned to one of three parallel groups (n=20 per group) using a computer-generated randomization sequence. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes. Outcome assessors (a dermatologist and a laboratory technician) will be blinded to group assignment.

Interventions:

Group A (Standard Care): Participants will continue their usual dermatologic care as prescribed by their physician, without any dietary or physical therapy intervention.

Group B (Diet Only): Participants will receive a 12-week anti-inflammatory diet that is gluten-free and low in histamine, designed by a registered pediatric dietitian. The diet eliminates all sources of gluten and foods high in histamine. For overweight or obese participants, a mild energy restriction will be included. Dietary adherence will be monitored via three-day food diaries.

Group C (Diet + Physical Therapy): Participants will receive the same dietary intervention as Group B, in addition to a 12-week physical therapy program. This program consists of 45-minute sessions, three times per week, comprising a warm-up, low-impact aerobic activities, and relaxation/breathing exercises. Sessions will be led by a pediatric physical therapist.

Study Schedule:

Assessments will be conducted at baseline (Week 0), mid-intervention (Week 6), and post-intervention (Week 12). The total duration of study participation for each participant is 14 weeks, including a 2-week screening period and a 12-week treatment period.

Statistical Analysis:

Data will be analyzed using a mixed repeated-measures ANOVA to test for group × time interactions. Intention-to-treat analysis will be performed. The significance level will be set at p < 0.05. Sample size calculation (n=20 per group) is based on an expected moderate effect size for the difference in P-PASI change between groups, with 80% power and α = 0.05.

Ethical Considerations:

The study protocol has been approved by the Faculty of Physical Therapy Research Ethics Committee at Cairo University. All participants and their parents or legal guardians will provide written informed consent and assent (for children 8-17 years) before enrollment. The study will be conducted in accordance with the Declaration of Helsinki and applicable local regulations.

Inclusion criteria

• Confirmed diagnosis of plaque psoriasis by a board-certified dermatologist for at least six months prior to enrollment.
• Age between 6 and 17 years (inclusive) at the time of enrollment.
• Mild to moderate disease severity, defined as a Pediatric Psoriasis Area and Severity Index (P-PASI) score ≤ 20 at the screening visit.
• Stable psoriasis treatment regimen (topical or systemic) for at least eight weeks prior to the baseline assessment. Participants may continue their usual treatments throughout the study.
• Ability to comply with the dietary protocol (gluten-free, low-histamine anti-inflammatory diet) and, for Group C, the physical therapy program, as judged by the investigator.
• Written informed consent from a parent or legal guardian.
• Written assent from the child (for participants aged 8-17 years). For children aged 6-7 years, verbal assent will be documented.
• Ability to attend all scheduled study visits at the outpatient clinics of Cairo University.

Exclusion criteria

• Known celiac disease or confirmed wheat allergy (documented by prior diagnostic testing).
• Current use of anticoagulant medications or systemic corticosteroids.
• Presence of other chronic inflammatory or autoimmune diseases that could confound the results (e.g., juvenile idiopathic arthritis, inflammatory bowel disease, systemic lupus erythematosus).
• Severe obesity defined as body mass index (BMI) greater than the 99th percentile for age and sex, which would limit participation in physical activity.
• Mental, behavioral, or developmental disorders that would prevent the child from cooperating with the dietary or physical therapy interventions or completing the assessments.
• Participation in another interventional clinical trial within the previous three months prior to enrollment.
• Any acute illness at the time of recruitment (e.g., febrile illness, acute infection, or acute exacerbation of psoriasis requiring immediate medical intervention).
• Known intolerance or allergy to multiple foods included in the diet (e.g., fish, nuts, or other common food allergens) that would make it difficult to adhere to the dietary protocol.
• Receiving any investigational drug or biologic therapy for psoriasis within the previous three months.
• Concurrent participation in another weight loss or exercise program that would interfere with the study interventions.