Action Observation Training in Patients With Chronic Low Back Pain

NCT04157374 | Withdrawn DMC

• 1 other identifier: CLF19/01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

AOT; Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

AOT and Active exercises

Other: Action Observation training; Other: Active Exercises

Control group

ACTIVE COMPARATOR

Active exercises

Other: Active Exercises

Interventions

Action Observation training OTHER

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.

Also known as: AOT

EXPERIMENTAL GROUP

Active Exercises OTHER

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.

Control group; EXPERIMENTAL GROUP

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients with chronic aspecific LBP (documented story of more than 12 week-long symptomatology)
• Good understanding of Italian language
• Aged over 65

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Roberto Gatti

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physiotherapy

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: November 8, 2019
• Study Start: May 29, 2019
• Primary Completion: January 10, 2021
• Study Completion: July 30, 2022
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)