LBP-AOT: Action Observation Training in Patients With Chronic Low Back Pain

Sponsor

Istituto Clinico Humanitas (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04157374

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
AOT Low Back Pain	Other: Action Observation training Other: Active Exercises	N/A

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

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Action Observation Training in Patients With Chronic Low Back Pain

Actual Study Start Date :

May 29, 2019

Actual Primary Completion Date :

Jan 10, 2021

Anticipated Study Completion Date :

Jul 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EXPERIMENTAL GROUP AOT and Active exercises	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. Other Names: AOT Other: 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.
Active Comparator: Control group Active exercises	Other: 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.

Arm

Intervention/Treatment

Experimental: EXPERIMENTAL GROUP

AOT and Active exercises

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.

Other Names:

AOT

Other: 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.

Active Comparator: Control group

Active exercises

Other: Active Exercises

Outcome Measures

Primary Outcome Measures

Change of disability 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)]
Change in Oswestry Disability Index (ODI-I). Range: 0 (lower disability), 50 (higher disability)

Secondary Outcome Measures

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)]
Numeric rating Scale (NRS), Range: 0 (no pain), 10 (maximum pain)
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)]
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 [Patients will be evaluated before the treatment (T0), three weeks after the beginning (T1) and 4 months upon the end of it (T2)]
TAMPA Scale of kinesiophobia, Range: 13 (minimum level of kinesiophobia)- 52 (maximum level of kinesiophobia).

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roberto Gatti	Rozzano	Milan	Italy	20089

Sponsors and Collaborators

Istituto Clinico Humanitas

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Jan 30, 2019

More Information

Publications

None provided.

Responsible Party:

Michele Tedeschi, Head of Physiotherapy, Istituto Clinico Humanitas

ClinicalTrials.gov Identifier:

NCT04157374

Other Study ID Numbers:

CLF19/01

First Posted:

Nov 8, 2019

Last Update Posted:

Sep 16, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of Sep 16, 2021