Action Observation Training in Patients With Chronic Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- Change of disability of patients
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change of disability of patients
Time Frame: Patients will be evaluated before the treatment (T0), three weeks after the beginning (T1) and 4 months upon the end of it (T2)
Change in Oswestry Disability Index (ODI-I). Range: 0 (lower disability), 50 (higher disability)
Secondary Outcomes
- Pain of patients(Patients will be evaluated before the treatment (T0), three weeks after the beginning (T1) and 4 months upon the end of it (T2))
- Quality of life of patients(Patients will be evaluated before the treatment (T0), three weeks after the beginning (T1) and 4 months upon the end of it (T2))
- fear of movement of patients(Patients will be evaluated before the treatment (T0), three weeks after the beginning (T1) and 4 months upon the end of it (T2))
Investigators
Michele Tedeschi
Head of Physiotherapy
Istituto Clinico Humanitas