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

NCT ID: NCT05391165

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-12

Study Completion Date

2022-12-14

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Back school

Intervention Type BEHAVIORAL

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.

Control group

I declare that I will not change my lifestyle during the study process.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Vigo

OTHER

Sponsor Role lead

Responsible Party

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Pablo Hernandez-Lucas

Associate professor in health sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beone Sport center

Pontevedra, , Spain

Site Status

Countries

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Spain

References

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Hernandez-Lucas P, Leiros-Rodriguez R, Mota J, Garcia-Soidan JL. Effects of a back school-based intervention on non-specific low back pain in adults: a randomized controlled trial. BMC Complement Med Ther. 2023 Jul 10;23(1):229. doi: 10.1186/s12906-023-04061-1.

Reference Type DERIVED
PMID: 37430269 (View on PubMed)

Other Identifiers

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6009

Identifier Type: -

Identifier Source: org_study_id

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