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NCT Number: NCT07749833

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

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.

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Key information

Conditions

Low Back Pain Back Pain Low Back Dysfunction Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Cairo University

Cairo, Cairo Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI-Driven Rehabilitation Program

Other

A personalized rehabilitation program guided by artificial intelligence, including individualized exercise prescription and progression.

Traditional physical therapy program

Other

A conventional physical therapy rehabilitation program delivered according to the study protocol

Primary outcomes

  1. Pain Intensity

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

    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).

Secondary outcomes

  1. Functional Performance

    Time frame: Baseline and after 6 weeks.

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

  2. Cost-effectiveness

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

    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.

  3. Lumbar Range of Motion

    Time frame: Baseline and after 6 weeks.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Dalia A Youssef, MSc, PT

CONTACT

[email protected]

+20 101 578 8109

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Efficacy of an Artificial Intelligence-Driven Program Versus a Traditional Physical Therapy Program in Patients With Low Back Dysfunction

Acronym: AI-LBD

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 6, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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