EFFICACY OF ARTIFICIAL INTELLIGENCE DRIVEN PROGRAM VERSUS TRADITIONAL PHYSICAL THERAPY PROGRAM IN PATIENTS WITH LOW BACK DYSFUNCTION

N/ANot Yet RecruitingNCT07749833

Cairo University68 enrolled

Overview

Low back dysfunction is one of the most common musculoskeletal disorders and is associated with pain, disability, and reduced quality of life. Artificial intelligence (AI) has emerged as a promising tool to support personalized rehabilitation by improving exercise prescription, monitoring adherence, and providing real-time feedback. This randomized controlled trial aims to compare the effectiveness of an AI-driven rehabilitation program with a traditional physical therapy program in patients with low back dysfunction. Primary outcomes include pain intensity, functional disability, and quality of life. The findings may provide evidence regarding the role of AI-assisted rehabilitation in improving clinical outcomes.

This study is a prospective randomized controlled trial designed to evaluate the efficacy of an artificial intelligence-driven rehabilitation program compared with a traditional physical therapy program in patients with low back dysfunction. Eligible participants will be randomly allocated into two groups. The experimental group will receive an AI-driven rehabilitation program, while the control group will receive a standardized traditional physical therapy program. Clinical outcomes will be assessed before and after the intervention using validated outcome measures for pain, functional disability, quality of life, and other variables specified in the study protocol. The study aims to determine whether integrating artificial intelligence into rehabilitation provides superior clinical outcomes compared with conventional physical therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged 18-45 years. * Male or female participants. * Clinical diagnosis of low back dysfunction by a physiotherapist or physician. * Symptoms lasting more than 3 months. * Ability to participate in physical therapy or use AI-based rehabilitation tools. * Willingness to comply with the study protocol and provide written informed consent. Exclusion Criteria: * Recent spinal injury or spinal surgery. * Previous spinal surgery within the last 6 months. * Severe neurological disorders (e.g., multiple sclerosis or Parkinson's disease). * Chronic conditions that significantly limit mobility (e.g., advanced arthritis). * Current use of strong opioid analgesics. * Severe psychiatric disorders. * Inability to use or access the required technology for the AI intervention.

Outcomes

Primary Outcomes

Pain Intensity

Pain intensity measured using the Visual Analogue Scale (VAS), a 10-cm self-reported pain scale ranging from 0 (no pain) to 10 (worst imaginable pain).

Time frame: Baseline and immediately post intervention 6 weeks of treatment.

Secondary Outcomes

Functional Performance

Functional performance measured using the Back Performance Scale (BPS). The total score ranges from 0 to 15, with higher scores indicating greater functional limitation.

Time frame: Baseline and after 6 weeks.

Cost-effectiveness

Cost-effectiveness assessed using the Incremental Cost-Effectiveness Ratio (ICER), based on total costs and clinical effectiveness of the AI-driven and traditional physical therapy programs,including direct medical costs, intervention-related costs, and healthcare utilization costs.

Time frame: After completion of the 6-week intervention.

Lumbar Range of Motion

Lumbar range of motion assessed using the Back Range of Motion (BROM II) device measuring lumbar flexion, extension, lateral flexion, and rotation.