Prevention of Neck Pain in Adults With a Back School-Based Intervention.
Primary Purpose
Neck Pain, Exercise Therapy, Health Education
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Back School
Sponsored by
About this trial
This is an interventional prevention trial for Neck Pain
Eligibility Criteria
Inclusion Criteria:
- Ages 18 - 65 years old.
- Not have had neck pain in the last 6 months.
Exclusion Criteria:
- 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.
Sites / Locations
- Pablo Hernández Lucas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
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.
I declare that I will not change my lifestyle during the study process.
Outcomes
Primary Outcome Measures
Changes in the incidence of neck pain.
Participants recorded the number of episodes of neck pain in a diary.
Changes in the duration of neck pain.
Participants recorded the number of days of neck pain in a diary.
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).
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.
Secondary Outcome Measures
Neck flexor muscle endurance.
This was measured using the deep neck flexor endurance test as described by Grimmer (1994). When in supine position, participants were asked to flex the upper cervical spine, move their heads away from the couch approximately 2.5 cm and hold this position for as long as possible. The test ended when students dropped their heads or lost craniocervical flexion.
Neck extensor muscle endurance.
The neck extensor endurance test was performed in line with the guidelines by Edmondston et al (2008). Students were in prone position, head neutral, arms by their sides and a 10-cm stabilising strip of Velcro was placed at the sixth dorsal vertebra level. An inclinometer and 5-cm strap were placed around the participants head with a 2-kg weight hanging from it. Participants were asked to support this weight for as long as possible while maintaining a neutral head position.
Scapular stabiliser endurance
Endurance of the scapular stabilisers was assessed as described by Edmondston et al (2008). Participants stood with their shoulders and elbows flexed at 90°. Students' elbows were kept approximately shoulder-distance apart with a ruler and they were asked to pull both extremities of the dynamometer by externally rotating their shoulders until the dynamometer reached 1 kg. They were asked to hold this position for as long as possible.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05260645
Brief Title
Prevention of Neck Pain in Adults With a Back School-Based Intervention.
Official Title
Prevention of Neck Pain in Adults With a Back School-Based Intervention.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vigo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Exercise Therapy, Health Education, Primary Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
I declare that I will not change my lifestyle during the study process.
Intervention Type
Behavioral
Intervention Name(s)
Back School
Intervention Description
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 Outcome Measure Information:
Title
Changes in the incidence of neck pain.
Description
Participants recorded the number of episodes of neck pain in a diary.
Time Frame
From the end of the back school intervention until 12 months of follow-up
Title
Changes in the duration of neck pain.
Description
Participants recorded the number of days of neck pain in a diary.
Time Frame
From the end of the back school intervention until 12 months of follow-up
Title
Changes in the Numeric Pain Rating Scale.
Description
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).
Time Frame
From the end of the back school intervention until 12 months of follow-up
Title
Changes in the medical visits from baseline to eight months.
Description
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.
Time Frame
From the end of the back school intervention until 12 months of follow-up
Secondary Outcome Measure Information:
Title
Neck flexor muscle endurance.
Description
This was measured using the deep neck flexor endurance test as described by Grimmer (1994). When in supine position, participants were asked to flex the upper cervical spine, move their heads away from the couch approximately 2.5 cm and hold this position for as long as possible. The test ended when students dropped their heads or lost craniocervical flexion.
Time Frame
Baseline and two months.
Title
Neck extensor muscle endurance.
Description
The neck extensor endurance test was performed in line with the guidelines by Edmondston et al (2008). Students were in prone position, head neutral, arms by their sides and a 10-cm stabilising strip of Velcro was placed at the sixth dorsal vertebra level. An inclinometer and 5-cm strap were placed around the participants head with a 2-kg weight hanging from it. Participants were asked to support this weight for as long as possible while maintaining a neutral head position.
Time Frame
Baseline and two months.
Title
Scapular stabiliser endurance
Description
Endurance of the scapular stabilisers was assessed as described by Edmondston et al (2008). Participants stood with their shoulders and elbows flexed at 90°. Students' elbows were kept approximately shoulder-distance apart with a ruler and they were asked to pull both extremities of the dynamometer by externally rotating their shoulders until the dynamometer reached 1 kg. They were asked to hold this position for as long as possible.
Time Frame
Baseline and two months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ages 18 - 65 years old.
Not have had neck pain in the last 6 months.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Pablo Hernández Lucas
City
Pontevedra
ZIP/Postal Code
36004
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Prevention of Neck Pain in Adults With a Back School-Based Intervention.
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