Action Observation Training in Patients With Chronic Low Back Pain

Low Back Pain Clinical Trial

— LBP-AOT  

Official title:

Action Observation Training in Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04157374
• Other study ID #: CLF19/01
• Status: Withdrawn
• Phase: N/A
• Start date: May 29, 2019
• Est. completion date: July 30, 2022

Study information

• Verified date: September 2021
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 30, 2022
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AOT
• Back Pain
• Low Back Pain

Intervention

Other:
• Action Observation training
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.
• Active Exercises
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.

Locations

Country	Name	City	State
Italy	Roberto Gatti	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of disability of patients	Change in Oswestry Disability Index (ODI-I). Range: 0 (lower disability), 50 (higher disability)	Patients will be evaluated before the treatment (T0), three weeks after the beginning (T1) and 4 months upon the end of it (T2)
Secondary	Pain of patients	Numeric rating Scale (NRS), Range: 0 (no pain), 10 (maximum pain)	Patients will be evaluated before the treatment (T0), three weeks after the beginning (T1) and 4 months upon the end of it (T2)
Secondary	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.	Patients will be evaluated before the treatment (T0), three weeks after the beginning (T1) and 4 months upon the end of it (T2)
Secondary	fear of movement of patients	TAMPA Scale of kinesiophobia, Range: 13 (minimum level of kinesiophobia)- 52 (maximum level of kinesiophobia).	Patients will be evaluated before the treatment (T0), three weeks after the beginning (T1) and 4 months upon the end of it (T2)