Chronic Neck PainNCT02046876
Swimming Adapted, Therapeutic Exercise and Health Education in the Treatment of Chronic Neck Pain
A study testing Multimodal Physiotherapy Program in people with Chronic Neck Pain, run by University of Malaga at 1 site in Spain.
Trial summary
Chronic neck pain (CNP) is defined as pain or intense discomfort in the lateral or back of the neck with an establishment and/or persistence period of over 12 weeks. The socio-economic system is seriously affected by chronic neck pain due to direct and indirect costs on the health system Physical exercise is used to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Multimodal Physiotherapy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Jun 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suffers Neck Pain for more than 12 weeks.
- Delivery of informed consent.
Who cannot join
- Neck pain due to an identifiable cause.
- Surgery on the spine in the 12 month
- Traffic accident in the last 3 months
- Cervical radiculopathy
- Pregnancy.
- Patients who suffered a condition that could alter the effects of treatment
- People who could not swim and/or present treatment difficulty.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Patronato Municipal de Deportes de Torremolinos
Torremolinos, Málaga, 29620
About this study
Chronic neck pain (CNP) is defined as pain or intense discomfort in the lateral or back of the neck with an establishment and/or persistence period of over 12 weeks.
The socio-economic system is seriously affected by chronic neck pain due to direct and indirect costs on the health system Physical exercise is used to improve physical function and reduce the symptoms of pain and stiffness due to chronic neck pain.
Read more
It has been demonstrated that therapeutic exercise in water is effective to improve functional capacity and symptoms in patients with chronic neck pain. In adition, health education and posture is an important component of the overall treatment of neck pain.
Interventions that integrate physical activity, adapted swimming and health education as an intervention for chronic neck pain sufferers have not been found. Furthermore the aim of this study is to analyse the effect of a physiothperapy treatment that combine adapted swimming, therapeutic exercise and health education in patients with chronic neck pain.
Hypothesis: the present intervention will be an effective tool to treat patients suffering chronic neck pain.
Methods: chronic neck pain patients from a community-based centre will be recruite participate in this prospective study.
Intervention: 60 min session: 30 min of land exercise dedicated to improve mobility, motor control, resistance and strengthening of the neck muscles, 30 min of adapted swimming with aerobic exercise keeping neutral neck position by using a snorkel. Health education will be provided by the physiotherapist before and during the sessions using a decalogue on chronic neck pain and constant repetition of brief advice.
Study outcomes: disability (Neck Disability Index), physical and mental health state and quality of life of patients (SF-12 and EuroQoL 5D respectively).
Differences between baseline data and that at the 8-week follow-up were calculated for all outcome variables.
Statistical Analysis: descriptive statistics. Analysis of the normal distribution of the variables using the KS-test. Comparison of variables pre - post intervencición: T-Student for parametric variables and Wilcoxon test for non parametric variables.
Data will be analysed descriptively and for statistical significance using Statistical Package for the Social Sciences (SPSS) (version 17.0 for Windows, Illinois, USA).
- Conditions
- Chronic Neck Pain
- Being tested
- Multimodal Physiotherapy Program
- Keywords
- neck pain, physiotherapy, adapted swimming, therapeutic exercises, health education
- 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.
Multimodal Physiotherapy ProgramOther
Multimodal Physiotherapy Program integrates: physical land-based therapeutic exercise, adapted swimming and health education
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Physiotherapy Program for Chronic Neck Pain Suffers | Experimental | Not described Receives: Other: Multimodal Physiotherapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Disability due to Chonic Neck Pain
Measured: Change from baseline in NDI at 8 weeks (post-treatment)
Neck Disability Index
Disability due to Chonic Neck Pain
Measured: Change from baseline in NDI at 6 month (follow-up)
Neck Disability Index
Disability due to Chonic Neck Pain
Measured: Change from baseline in NDI at 12 month (follow-up)
Secondary outcomes (2)
Short Form 12
General Health State Questionnaire
Measured: pre and post intervention and 6 and 12 months of follow up
EuroQoL 5 Dimensions
Health Related Quality of Life Questionnaire
Measured: pre and post intervention and 6 and 12 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJun 2013
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 Chronic 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
- Investigators
- Antonio I Cuesta-Vargas, PhD, Principal investigator, University of Malaga and Faculty of Health at the Queensland University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046876
- Sponsor's protocol ID
- UMA-1301
- Status last verified
- Jan 2014
- First submitted
- 24 Dec 2013
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cuesta-Vargas AI, Gonzalez-Sanchez M. Changes in disability, physical/mental health states and quality of life during an 8-week multimodal physiotherapy programme in patients with chronic non-specific neck pain: a prospective cohort study. PLoS One. 2015 Feb 24;10(2):e0118395. doi: 10.1371/journal.pone.0118395. eCollection 2015.
PubMed 25710539
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swimming Adapted, Therapeutic Exercise and Health Education in the Treatment of Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT02046876
- Acronym / sponsor ID
- UMA-1301
- Conditions
- Chronic Neck Pain
- Keywords
- neck pain, physiotherapy, adapted swimming, therapeutic exercises, health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Jan 2014 (estimated)
- 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.
Chronic neck pain (CNP) is defined as pain or intense discomfort in the lateral or back of the neck with an establishment and/or persistence period of over 12 weeks.
The socio-economic system is seriously affected by chronic neck pain due to direct and indirect costs on the health system Physical exercise is used to improve physical function and reduce the symptoms of pain and stiffness due to chronic neck pain.
It has been demonstrated that therapeutic exercise in water is effective to improve functional capacity and symptoms in patients with chronic neck pain. In adition, health education and posture is an important component of the overall treatment of neck pain.
Interventions that integrate physical activity, adapted swimming and health education as an intervention for chronic neck pain sufferers have not been found. Furthermore the aim of this study is to analyse the effect of a physiothperapy treatment that combine adapted swimming, therapeutic exercise and health education in patients with chronic neck pain.
Hypothesis: the present intervention will be an effective tool to treat patients suffering chronic neck pain.
Methods: chronic neck pain patients from a community-based centre will be recruite participate in this prospective study.
Intervention: 60 min session: 30 min of land exercise dedicated to improve mobility, motor control, resistance and strengthening of the neck muscles, 30 min of adapted swimming with aerobic exercise keeping neutral neck position by using a snorkel. Health education will be provided by the physiotherapist before and during the sessions using a decalogue on chronic neck pain and constant repetition of brief advice.
Study outcomes: disability (Neck Disability Index), physical and mental health state and quality of life of patients (SF-12 and EuroQoL 5D respectively).
Differences between baseline data and that at the 8-week follow-up were calculated for all outcome variables.
Statistical Analysis: descriptive statistics. Analysis of the normal distribution of the variables using the KS-test. Comparison of variables pre - post intervencición: T-Student for parametric variables and Wilcoxon test for non parametric variables.
Data will be analysed descriptively and for statistical significance using Statistical Package for the Social Sciences (SPSS) (version 17.0 for Windows, Illinois, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal Physiotherapy Program for Chronic Neck Pain Suffers | Experimental | Other: Multimodal Physiotherapy Program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suffers Neck Pain for more than 12 weeks.
- Delivery of informed consent.
Key exclusion criteria (7 listed)
- Neck pain due to an identifiable cause.
- Surgery on the spine in the 12 month
- Traffic accident in the last 3 months
- Cervical radiculopathy
- Pregnancy.
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 |
|---|---|---|
| Multimodal Physiotherapy ProgramMultimodal Physiotherapy Program integrates: physical land-based therapeutic exercise, adapted swimming and health education | Other | Multimodal Physiotherapy Program for Chronic Neck Pain Suffers |
Primary outcome
Neck Disability Index
Time frame: Change from baseline in NDI at 8 weeks (post-treatment)
Disability due to Chonic Neck Pain
Neck Disability Index
Time frame: Change from baseline in NDI at 6 month (follow-up)
Disability due to Chonic Neck Pain
Neck Disability Index
Time frame: Change from baseline in NDI at 12 month (follow-up)
Disability due to Chonic Neck Pain
2 secondary outcomes
Short Form 12
Time frame: pre and post intervention and 6 and 12 months of follow up
EuroQoL 5 Dimensions
Time frame: pre and post intervention and 6 and 12 months of follow up
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 28 Jan 2014.
- Derived from this study: PubMed 25710539Cuesta-Vargas AI, Gonzalez-Sanchez M. Changes in disability, physical/mental health states and quality of life during an 8-week multimodal physiotherapy programme in patients with chronic non-specific neck pain: a prospective cohort study. PLoS One. 2015 Feb 24;10(2):e0118395. doi: 10.1371/journal.pone.0118395. eCollection 2015.
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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.
Antonio I Cuesta-Vargas, PhD principal investigator
University of Malaga and Faculty of Health at the Queensland University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Physiotherapy Program in people with Chronic Neck Pain, run by University of Malaga 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 7 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 28 Jan 2014. 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?
Neck Disability Index (time frame: Change from baseline in NDI at 8 weeks (post-treatment)). The study lists 3 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 NCT02046876, 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 28 Jan 2014.