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CompletedNCT05244876Updated Oct 26, 2022

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

An interventional study of Back school in Neck Pain, Exercise Therapy and Health Education, sponsored by University of Vigo. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-10-26.

Sponsored by University of Vigo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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; Neck Disability Index; 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 neck 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.

02

Conditions studied

  • Neck Pain
  • Exercise Therapy
  • Health Education

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03

In context

Neck Pain

1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.

This study's enrollment of 60 is above the median of 52 across 1,004 interventional studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

University of Vigo is the lead sponsor of 53 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any previous neck or shoulder surgery, fibromyalgia, cervical radiculopathy/myelopathy, history of the whiplash injury, cognitive disorder.
  • Missing more than two Back School sessions.
  • Not being able to attend the measurement sessions.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Experimental group

    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

  • No intervention
    Control group

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

Interventions

  • BehavioralBack 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Through study completion, an average of 2 months.

  2. Neck Disability Index

    The NDI can be scored as a raw scorer doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.

    Time frame: Through study completion, an average of 2 months.

  3. 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).

    Time frame: Through study completion, an average of 2 months.

  4. 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.

    Time frame: Through study completion, an average of 2 months.

07

Study locations

1 site
  • Pablo Hernández Lucas
    Pontevedra, 36004, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05244876
Lead sponsor
University of Vigo
Responsible party
Pablo Hernandez-Lucas (Associate professor in health sciences, University of Vigo) — Principal investigator
First posted
Feb 17, 2022
Start date
May 16, 2022
Primary completion
Jul 8, 2022
Completion
Jul 8, 2022
Last update
Oct 26, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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