Clinical trial NCT05391165: Effect of Back School-based Intervention on Non-specific Low Back Pain in Adults.
Official title: Effect of Back School-based Intervention on Non-specific Low Back Pain in Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Vigo
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Through study completion, an average of 2 months.
measure: Roland Morris Disability Questionnaire Scoring
timeFrame: Through study completion, an average of 2 months.
measure: Short-Form Health Survey-36
timeFrame: Through study completion, an average of 2 months.
measure: Tampa Scale Of Kinesiophobia.
timeFrame: Through study completion, an average of 2 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Pontevedra
country: Spain
facility: Beone Sport center
Study officials:
References: