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

Sponsor
University of Vigo (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05260645
Collaborator
(none)
60
1
2
8
7.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Back School
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Prevention of Neck Pain in Adults With a Back School-Based Intervention.
Actual Study Start Date :
Mar 14, 2022
Anticipated Primary Completion Date :
Nov 14, 2022
Anticipated Study Completion Date :
Nov 14, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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.

No Intervention: Control group

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

Outcome Measures

Primary Outcome Measures

  1. Changes in the incidence of neck pain from baseline to eight months. [Baseline and eight months.]

    Participants recorded the number of episodes of neck pain in a diary. These data were collected at the end of the intervention and 6 months follow-up.

  2. Changes in the duration of neck pain from baseline to eight months. [Baseline and eight months.]

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

  3. Changes in the Numeric Pain Rating Scale from baseline to eight months. [Baseline and eight months.]

    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).These data were collected at the end of the intervention and at 6-month follow-up.

  4. Changes in the medical visits from baseline to eight months. [Baseline and 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

  1. Neck flexor muscle endurance. [Baseline and two months.]

    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.

  2. Neck extensor muscle endurance. [Baseline and two months.]

    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.

  3. Scapular stabiliser endurance [Baseline and two months.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pablo Hernández Lucas Pontevedra Spain 36004

Sponsors and Collaborators

  • University of Vigo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pablo Hernandez-Lucas, Associate professor in health sciences, University of Vigo
ClinicalTrials.gov Identifier:
NCT05260645
Other Study ID Numbers:
  • 5148
First Posted:
Mar 2, 2022
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2022