Prevention of Neck Pain in Adults With a Back School-Based Intervention.

Study Overview
=================
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.

Official Title
-----------------
Prevention of Neck Pain in Adults With a Back School-Based Intervention.

Conditions
-----------------
Neck Pain, Exercise Therapy, Health Education, Primary Prevention

Intervention / Treatment
-----------------
* Behavioral: Back School


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>I declare that I will not change my lifestyle during the study process. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and two months. | 
| 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. | Baseline and two months. | 
| 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. | Baseline and two months. |