Skip to content

Feasibility of an artificial intelligent telerehabilitation platform to treat chronic low back pain: protocol for a clinical trial

Feasibility of a self-exercise machine learning-based telerehabilitation program on the management of chronic low back pain: protocol for a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16582502
Enrollment
45
Registered
2023-02-10
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic unspecific low back pain Musculoskeletal Diseases

Interventions

All potential participants will attend a briefing session prior to the start of the program to receive a description of the research project, conduct eligibility screening and provide informed consent

Sponsors

University of Coimbra
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Presence of unspecific chronic low back pain, defined as having been recognized in the previous 4 weeks and having persisted beyond 3 months 2. Adults over 18 years of age 3. Provision of informed consent to participate in the study 4. Ability to use a computer

Exclusion criteria

Exclusion criteria: 1. Specific cause of low back pain (e.g. spinal compression fracture, neurological conditions, cancer or inflammatory diseases affecting the low back spine such as rheumatic arthritis) 2. Cognitive impairment which would impact their ability to comprehend the exercise orientations and answer the questionnaires 3. Insufficient Portuguese reading and writing skills to complete questionnaires and to comprehend and participate in the telerehabilitation exercises 4. Comorbid health conditions that would be contraindications for exercise 5. Recent spinal surgery (within preceding 12 months)

Design outcomes

Primary

MeasureTime frame
1. Usability measured using the following methods: after 6, and after 12 weeks 1.1. The Portuguese version of the System Usability Scale (SUS) 1.2. The Telehealth Usability Questionnaire (TUQ) 2. Adherence and treatment fidelity is measured using the percentage of participants who will adhere to the intervention and the dropout percentage after 6 weeks and after 12 weeks 3. Safety of the telerehabilitation platform assessed by measuring the following variables between the intervention and control group after 6 weeks and after 12 weeks 3.1. Incidence of adverse events measured using a questionnaire.

Secondary

MeasureTime frame
Timepoint(s): at the beginning of the study, after 6 and after 12 weeks 1. Physical and functionality outcomes 1.1. Pain intensity measured using a numeric rating scale (NRS) and the Brief pain inventory (BPI) 1.2. Functional limitations measured using the Roland-Morris disability questionnaire (RDQ) 2. Economic variables 2.1. Care-seeking associated with low back pain for the last three months, such as any visits to a health practitioner (i.e. doctor, physiotherapist, chiropractor, etc), type of self-management (i.e. heat pack, bed rest, hot shower, etc), and medication intake (type and dose of medication taken) measured using a questionnaire 2.2. Number of days out of work due to low back pain for the last three months measured using a questionnaire 3. Psychological variables 3.1. Fear of movement related to chronic lower back pain measured using the Tampa Scale for Kinesiophobia (TSK) 3.2. Depression, anxiety, and stress measured using the Depression Anxiety Stress Scales (DASS) 4. Quality of life measured using the Portuguese version of the Medical Outcomes Study (MOS) 36-Item Short Form Survey (SF-26)

Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026