Effect of Back School-based Intervention on Non-specific Low Back Pain in Adults.

The study consists of a theoretical and practical intervention based on the Back School. This intervention will be carried out over 8 weeks with a frequency of two sessions per week, for a total of 16 sessions of 45 minutes duration. Of all the sessions, 14 had a practical focus (strength and stretching exercises) and the other two had a theoretical focus (self-management techniques and pain neuroscience education). In addition, they had an initial session and a session at the end of the of the intervention in which measurements of the different variables were taken (The Visual Analogue Scale; Roland morris disability questionnaire scoring; Short Form 36 Health Survey; Tampa Scale Of kinesiophobia).These variables will be measured on two occasions, at the beginning of the study and at the end of the intervention, an average of 2 months.

The clinical practice guidelines highlight the importance of neck pain prevention through exercise an education. There are previous studies of the effects of theoretical and practical programmes based on back school on the lumbar region but not on the cervical region. Therefore, the aim of this study is to investigate the effects of a BS-based intervention on low back pain and functionality as well as kinesiophobia and quality of life in adults. The hypothesis previously hypothesised that this BS-based intervention would have positive effects on pain, functionality, kinesiophobia and quality of life.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: Back school

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Pontevedra, Spain, 36003
    • Beone Sport center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-65 years of age. With non-specific low back pain for at least three months, with pain intensity (30-70 on a VAS).

Exclusion Criteria:

• History of cancer, spine infection, rheumatologic diseases, history of spine fracture, history of trauma, red flag signs including unwanted weight loss (exceeding 10 percent of the total body weight) in the past six months and fever, history of psychological disease and history of spine surgery, radiculopathy, anatomical and congenital disturbance.
• Missing more than two Back School sessions.
• Not being able to attend the measurement sessions.

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; ntervention based on the Back School was carried out for 8 weeks with a frequency of two sessions per week, with a total of 16 sessions lasting 45 min.	Behavioral: Back school; Intervention was carried out for 8 weeks with a frequency of two sessions per week, with a total of 16 sessions lasting 45 min. Of all the sessions, 14 had a practical focus and the other two had a theoretical focus. In the practical part, strengthening and stretching exercises were performed. In the theoretical part, self-management and pain neuroscience education were performed.
No Intervention: Control group; I declare that I will not change my lifestyle during the study process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score).	Through study completion, an average of 2 months.
Roland Morris Disability Questionnaire Scoring	The Roland Morris Disability Questionnaire Scoring (RMQ) is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24; higher scores represent higher levels of pain-related disability.	Through study completion, an average of 2 months.
Short-Form Health Survey-36	Short-Form Health Survey (SF-36) was used to measure quality of life.The SF-36 explores people's physical and mental health. It consists of 36 items that assessed eight dimensions of health status: social function, physical function, emotional role, physical role, mental health, vitality, physical pain, and general health. Scores ranged from 0 (worst health status) to 100 (best health status).	Through study completion, an average of 2 months.
Tampa Scale Of Kinesiophobia.	This scale measures kinesiophobia. The total scale score ranges from 11 to 44, where 11 means no kinesiophobia and 44 means severe kinesiophobia.	Through study completion, an average of 2 months.

Collaborators and Investigators

• Sponsor: University of Vigo

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Actual): November 14, 2022
• Study Completion (Actual): December 14, 2022

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 6009

Drug and device information, study documents

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