Neck PainNCT05260645
Prevention of Neck Pain in Adults With a Back School-Based Intervention.
A study testing Back School in people with Neck Pain and Exercise Therapy, run by University of Vigo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Exercise Therapy, Health Education
- What is being tested?
- Back School
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSpain
- Study dates
- 14 Mar 2022to 5 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18 - 65 years old.
- Not have had neck pain in the last 6 months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Neck Pain, Exercise Therapy, Health Education, Primary Prevention
- Being tested
- Back School
- Medical subject headings
- Neck Pain, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back SchoolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Behavioral: Back School |
| Control group | No intervention | I declare that I will not change my lifestyle during the study process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the incidence of neck pain.
Participants recorded the number of episodes of neck pain in a diary.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From the end of the back school intervention until 12 months of follow-up
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and two months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start14 Mar 2022
- Primary completion1 May 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Hernandez-Lucas, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260645
- Sponsor's protocol ID
- 5148
- Status last verified
- May 2023
- First submitted
- 8 Feb 2022
- Last updated
- 8 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hernandez-Lucas P, Leiros-Rodriguez R, Lopez-Barreiro J, Garcia-Soidan JL. Prevention of neck pain in adults with a Back School-Based intervention: a randomized controlled trial. Physiother Theory Pract. 2025 Jan;41(1):54-64. doi: 10.1080/09593985.2024.2316313. Epub 2024 Feb 16.
PubMed 38362871
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Neck Pain in Adults With a Back School-Based Intervention.
- ClinicalTrials.gov ID
- NCT05260645
- Acronym / sponsor ID
- 5148
- Conditions
- Neck Pain, Exercise Therapy, Health Education, Primary Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Back SchoolIntervention 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. |
| Control group | No intervention | –I declare that I will not change my lifestyle during the study process. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18 - 65 years old.
- Not have had neck pain in the last 6 months.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Back SchoolIntervention 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. | Behavioural | Experimental group |
Primary outcome
Changes in the incidence of neck pain.
Time frame: From the end of the back school intervention until 12 months of follow-up
Participants recorded the number of episodes of neck pain in a diary.
Changes in the duration of neck pain.
Time frame: From the end of the back school intervention until 12 months of follow-up
Participants recorded the number of days of neck pain in a diary.
Changes in the Numeric Pain Rating Scale.
Time frame: From the end of the back school intervention until 12 months of follow-up
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.
Time frame: From the end of the back school intervention until 12 months of follow-up
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.
3 secondary outcomes
Neck flexor muscle endurance.
Time frame: Baseline and two months.
Neck extensor muscle endurance.
Time frame: Baseline and two months.
Scapular stabiliser endurance
Time frame: Baseline and two months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Derived from this study: PubMed 38362871Hernandez-Lucas P, Leiros-Rodriguez R, Lopez-Barreiro J, Garcia-Soidan JL. Prevention of neck pain in adults with a Back School-Based intervention: a randomized controlled trial. Physiother Theory Pract. 2025 Jan;41(1):54-64. doi: 10.1080/09593985.2024.2316313. Epub 2024 Feb 16.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Back School in people with Neck Pain and Exercise Therapy, run by University of Vigo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the incidence of neck pain. (time frame: From the end of the back school intervention until 12 months of follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05260645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.