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

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

Study Overview

• Status: Withdrawn
• Conditions: Low Back Pain; AOT
• Intervention / Treatment: Other: Action Observation training; Other: Active Exercises

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Roberto Gatti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Actual): January 10, 2021
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CLF19/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No