NCT05260645

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). 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 main aim of this innovative study is to to investigate the effects of a Back School based intervention on the prevention of neck pain and as secondary objectives to investigate the effects on neck flexor and extensor strength as well as scapular stability. The hypothesis is that this BS-based intervention would have positive effects on neck pain prevention, neck strength and scapular stability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2023

Completed
Last Updated

May 8, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

February 8, 2022

Last Update Submit

May 4, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Changes in the incidence of neck pain.

    Participants recorded the number of episodes of neck pain in a diary.

    From the end of the back school intervention until 12 months of follow-up

  • Changes in the duration of neck pain.

    Participants recorded the number of days of neck pain in a diary.

    From the end of the back school intervention until 12 months of follow-up

  • Changes in the Numeric Pain Rating Scale.

    Participants recorded neck pain intensity in a diary using the Numeric Pain Rating Scale (0-10). The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

    From the end of the back school intervention until 12 months of follow-up

  • Changes in the medical visits from baseline to eight months.

    Participants recorded the number of medical visits for neck pain in a diary. These data were collected at the end of the intervention and at 6-month follow-up.

    From the end of the back school intervention until 12 months of follow-up

Secondary Outcomes (3)

  • Neck flexor muscle endurance.

    Baseline and two months.

  • Neck extensor muscle endurance.

    Baseline and two months.

  • Scapular stabiliser endurance

    Baseline and two months.

Study Arms (2)

Experimental group

EXPERIMENTAL

Intervention 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

Control group

NO INTERVENTION

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

Interventions

Back SchoolBEHAVIORAL

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.

Experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 - 65 years old.
  • Not have had neck pain in the last 6 months.

You may not qualify if:

  • Previous neck or shoulder surgery, cervical radiculopathy/myelopathy, history of the whiplash injury.
  • Taking any medication or having any musculoskeletal, rheumatic, metabolic, cardiological, cognitive disorder or neurological disorder.
  • Missing more than two Back School sessions.
  • Not being able to attend the measurement sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pablo Hernández Lucas

Pontevedra, 36004, Spain

Location

Related Publications (1)

  • Hernandez-Lucas P, Leiros-Rodriguez R, Lopez-Barreiro J, Garcia-Soidan JL. Prevention of neck pain in adults with a Back School-Based intervention: a randomized controlled trial. Physiother Theory Pract. 2025 Jan;41(1):54-64. doi: 10.1080/09593985.2024.2316313. Epub 2024 Feb 16.

MeSH Terms

Conditions

Neck PainHealth Education

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor in health sciences

Study Record Dates

First Submitted

February 8, 2022

First Posted

March 2, 2022

Study Start

March 14, 2022

Primary Completion

May 1, 2023

Study Completion

May 5, 2023

Last Updated

May 8, 2023

Record last verified: 2023-05

Locations