Action Observation Training in Patients With Chronic Low Back Pain (LBP-AOT)
Primary Purpose
AOT, Low Back Pain
Status
Withdrawn
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Action Observation training
Active Exercises
Sponsored by
About this trial
This is an interventional treatment trial for AOT
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
Sites / Locations
- Roberto Gatti
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EXPERIMENTAL GROUP
Control group
Arm Description
AOT and Active exercises
Active exercises
Outcomes
Primary Outcome Measures
Change of disability of patients
Change in Oswestry Disability Index (ODI-I). Range: 0 (lower disability), 50 (higher disability)
Secondary Outcome Measures
Pain of patients
Numeric rating Scale (NRS), Range: 0 (no pain), 10 (maximum pain)
Quality of life of patients
Short form 36.36 Items divided in 8 sub-scales. Each of the 8 summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each subscale. Each subscale is used indipendently.
fear of movement of patients
TAMPA Scale of kinesiophobia, Range: 13 (minimum level of kinesiophobia)- 52 (maximum level of kinesiophobia).
Full Information
NCT ID
NCT04157374
First Posted
August 6, 2019
Last Updated
September 8, 2021
Sponsor
Istituto Clinico Humanitas
1. Study Identification
Unique Protocol Identification Number
NCT04157374
Brief Title
Action Observation Training in Patients With Chronic Low Back Pain
Acronym
LBP-AOT
Official Title
Action Observation Training in Patients With Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of patients due to Covid-19 pandemic
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
January 10, 2021 (Actual)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Clinico Humanitas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AOT, Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EXPERIMENTAL GROUP
Arm Type
Experimental
Arm Description
AOT and Active exercises
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Active exercises
Intervention Type
Other
Intervention Name(s)
Action Observation training
Other Intervention Name(s)
AOT
Intervention Description
They have to watch a video showing a person carrying out exercises (12 exercises: 3 of stretching, 3 of core stability, 3 of mobilization and 3 of functional). then they have to practice them. The observation of the exercises and their performance last 8 minutes (4 minutes for observation and 4 minutes for practice). They have to repeat the exercises 5 times per week for 3 weeks.
Intervention Type
Other
Intervention Name(s)
Active Exercises
Intervention Description
Execution of exercises: 3 of stretching, 3 of core stability, 3 of mobilization and 3 of functional activity. Patients of the control group recieve a brochure with the same exercises the patients of the experimental group received through the video. They will be asked to read the exercise 3 times and to practice it for 4 minutes. They have to repeat the exercises 5 times per week for 3 weeks.
Primary Outcome Measure Information:
Title
Change of disability of patients
Description
Change in Oswestry Disability Index (ODI-I). Range: 0 (lower disability), 50 (higher disability)
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)
Secondary Outcome Measure Information:
Title
Pain of patients
Description
Numeric rating Scale (NRS), Range: 0 (no pain), 10 (maximum pain)
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)
Title
Quality of life of patients
Description
Short form 36.36 Items divided in 8 sub-scales. Each of the 8 summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each subscale. Each subscale is used indipendently.
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)
Title
fear of movement of patients
Description
TAMPA Scale of kinesiophobia, Range: 13 (minimum level of kinesiophobia)- 52 (maximum level of kinesiophobia).
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Roberto Gatti
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Action Observation Training in Patients With Chronic Low Back Pain
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