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Completed

NCT Number: NCT05244876

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

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.

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Key information

Conditions

Neck Pain Adherence Interventions Behavior Exercise Therapy Health Behavior Health Education Medication Adherence Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pablo Hernández Lucas

Pontevedra, 36004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Back School

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.

Primary outcomes

  1. Visual Analogue Scale

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

    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).

  2. Neck Disability Index

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

    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.

  3. Short-Form Health Survey-36

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

    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).

  4. Tampa Scale Of Kinesiophobia.

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

    This scale measures kinesiophobia. The total scale score ranges from 11 to 44, where 11 means no kinesiophobia and 44 means severe kinesiophobia.

Sponsors and collaborators

Lead sponsor

University of Vigo

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2022
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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