Clinical trial NCT02046876: Swimming Adapted, Therapeutic Exercise and Health Education in the Treatment of Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Keywords: neck pain
physiotherapy
adapted swimming
therapeutic exercises
health education
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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).


Eligibility criteria: Inclusion Criteria:

* Suffers Neck Pain for more than 12 weeks.
* Delivery of informed consent.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Neck Disability Index
timeFrame: Change from baseline in NDI at 8 weeks (post-treatment)
measure: Neck Disability Index
timeFrame: Change from baseline in NDI at 6 month (follow-up)
measure: Neck Disability Index
timeFrame: Change from baseline in NDI at 12 month (follow-up)
Secondary outcomes:
measure: Short Form 12
timeFrame: pre and post intervention and 6 and 12 months of follow up
measure: EuroQoL 5 Dimensions
timeFrame: pre and post intervention and 6 and 12 months of follow up
Other outcomes:
Locations:
city: Torremolinos
country: Spain
facility: Patronato Municipal de Deportes de Torremolinos
state: Málaga
Study officials:
affiliation: University of Malaga and Faculty of Health at the Queensland University of Technology
name: Antonio I Cuesta-Vargas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.