Low Back PainAI-LBDNCT07749833
EFFICACY OF ARTIFICIAL INTELLIGENCE DRIVEN PROGRAM VERSUS TRADITIONAL PHYSICAL THERAPY PROGRAM IN PATIENTS WITH LOW BACK DYSFUNCTION
A study testing AI-Driven Rehabilitation Program and Traditional Physical Therapy Program in people with Low Back Pain and Low Back Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Low Back Pain, Low Back Dysfunction
- What is being tested?
- AI-Driven Rehabilitation Program and Traditional Physical Therapy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Cairo University - Research Laboratory
Giza, Giza Governorate, 12613
Dalia Youssef, Master degree, +0201015788109, daliayoussef151023@gmail.com
Mohsen El Sayyad, Professor of Physical Therapy
About this study
Official title: Efficacy of an Artificial Intelligence-Driven Program Versus a 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.
Read the detailed description
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.
- Conditions
- Low Back Pain, Low Back Dysfunction
- Being tested
- AI-Driven Rehabilitation Program, Traditional Physical Therapy Program
- Keywords
- Artificial Intelligence, Low Back Dysfunction, Low Back Pain, Physical Therapy, Rehabilitation, Exercise Therapy, AI-Driven Rehabilitation, Musculoskeletal Rehabilitation, Randomized Controlled Trial, Personalized Rehabilitation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Driven Rehabilitation ProgramOther
A personalized rehabilitation program guided by artificial intelligence, including individualized exercise prescription and progression.
Traditional Physical Therapy ProgramOther
A conventional physical therapy rehabilitation program delivered according to the study protocol
| Study group | Role | What they receive |
|---|---|---|
| AI-Driven Rehabilitation | Experimental | Participants will receive an artificial intelligence-driven rehabilitation program including personalized exercise prescription, progression, and monitoring according to the study protocol. Receives: Other: AI-Driven Rehabilitation Program |
| Traditional Physical Therapy | Active comparator | Participants will receive a standardized traditional physical therapy rehabilitation program according to the study protocol. Receives: Other: Traditional Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and immediately post intervention 6 weeks of treatment.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start20 Aug 2026
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups: an AI-driven rehabilitation program or a traditional physical therapy program.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Ashraf Mohamed Youssef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749833
- Sponsor's protocol ID
- AI-LBD-20260803-1995-DA
- Acronym
- AI-LBD
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared to protect participant confidentiality and privacy.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Artificial Intelligence-Driven Program Versus a Traditional Physical Therapy Program in Patients With Low Back Dysfunction
- ClinicalTrials.gov ID
- NCT07749833
- Acronym / sponsor ID
- AI-LBD / AI-LBD-20260803-1995-DA
- Conditions
- Low Back Pain, Low Back Dysfunction
- Keywords
- Artificial Intelligence, Low Back Dysfunction, Low Back Pain, Physical Therapy, Rehabilitation, Exercise Therapy, AI-Driven Rehabilitation, Musculoskeletal Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: an AI-driven rehabilitation program or a traditional physical therapy program.
| Arm | Type | Receives |
|---|---|---|
| AI-Driven Rehabilitation | Experimental | Other: AI-Driven Rehabilitation ProgramParticipants will receive an artificial intelligence-driven rehabilitation program including personalized exercise prescription, progression, and monitoring according to the study protocol. |
| Traditional Physical Therapy | Active comparator | Other: Traditional Physical Therapy ProgramParticipants will receive a standardized traditional physical therapy rehabilitation program according to the study protocol. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Driven Rehabilitation ProgramA personalized rehabilitation program guided by artificial intelligence, including individualized exercise prescription and progression. | Other | AI-Driven Rehabilitation |
| Traditional Physical Therapy ProgramA conventional physical therapy rehabilitation program delivered according to the study protocol | Other | Traditional Physical Therapy |
Primary outcome
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).
3 secondary outcomes
Functional Performance
Time frame: Baseline and after 6 weeks.
Cost-effectiveness
Time frame: After completion of the 6-week intervention.
Lumbar Range of Motion
Time frame: Baseline and after 6 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared to protect participant confidentiality and privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Driven Rehabilitation Program and Traditional Physical Therapy Program in people with Low Back Pain and Low Back Dysfunction, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalia A Youssef, MSc, PT (+20 101 578 8109, Daliayoussef151023@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Baseline and immediately post intervention 6 weeks of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.