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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05391165
• Other study ID #: 6009
• Status: Completed
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: December 14, 2022

Study information

• Verified date: January 2023
• Source: University of Vigo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 14, 2022
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
Spain	Beone Sport center	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
University of Vigo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.