Clinical trial NCT04157374: Action Observation Training in Patients With Chronic Low Back Pain
Official title: Action Observation Training in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: AOT
Low Back Pain
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a single-blind controlled randomized clinical trial.

Detailed description: Patients will be recruited and then randomly assigned by an external collaborator to the experimental group or to the control group. To the patients that belong to the experimental group will be asked to watch a video showing a person carrying out some exercises (12 exercises: 3 of stretching, 3 of core stability, 3 of mobilization and 3 of functional) and then they will have to practice them.On the other hand, to the patients that belong to the control group will be given a brochure with the same exercises the patients of the experimental group received through the video. Both groups will have to watch the video or read the brochure and repeat the exercises 5 times per week for 3 weeks. Patients will be evaluated before the treatment (T0), three weeks after the beginning (T1) and 4 months upon the end of it (T2). The evaluation will consist in the administration of the Oswestry Disability Index, of the Tampa Scale of Kinesiophobia, of the Numerical Rating Scale and of the Medical Outcomes Study Short Form 36.

A physiotherapist will instruct the patients about the exercises while a second one blinded about the belonging group of patients, will administer the evaluation scales.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic aspecific LBP (documented story of more than 12 week-long symptomatology)
* Good understanding of Italian language
* Aged over 65

Exclusion Criteria:

* Severe sight or hearing impairement
* Cognitive deficit (assessed by a Mini Mental State Examination score ≤21 \[14\]).
* Specific LBP (previous spine surgery, deformation, infection, fracture, malignant tumor, general disorders or neuromuscular pathologies)
* Patients who previously experimented AOT

Primary outcomes:
measure: Change of disability of patients
timeFrame: Patients will be evaluated before the treatment (T0), three weeks after the beginning (T1) and 4 months upon the end of it (T2)
Secondary outcomes:
measure: Pain of patients
timeFrame: Patients will be evaluated before the treatment (T0), three weeks after the beginning (T1) and 4 months upon the end of it (T2)
measure: Quality of life of patients
timeFrame: Patients will be evaluated before the treatment (T0), three weeks after the beginning (T1) and 4 months upon the end of it (T2)
measure: fear of movement of patients
timeFrame: Patients will be evaluated before the treatment (T0), three weeks after the beginning (T1) and 4 months upon the end of it (T2)
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Roberto Gatti
state: Milan
Study officials:
References: