Swimming Adapted, Therapeutic Exercise and Health Education in the Treatment of Chronic Neck Pain

Chronic Neck Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046876
• Other study ID #: UMA-1301
• Status: Completed
• Phase: N/A
• First received: December 24, 2013
• Last updated: January 24, 2014
• Start date: January 2013
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Neck Pain
• Neck Pain

Intervention

Other:
• Multimodal Physiotherapy Program
Multimodal Physiotherapy Program integrates: physical land-based therapeutic exercise, adapted swimming and health education

Locations

Country	Name	City	State
Spain	Patronato Municipal de Deportes de Torremolinos	Torremolinos	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Disability Index	Disability due to Chonic Neck Pain	Change from baseline in NDI at 8 weeks (post-treatment)	Yes
Primary	Neck Disability Index	Disability due to Chonic Neck Pain	Change from baseline in NDI at 6 month (follow-up)	Yes
Primary	Neck Disability Index	Disability due to Chonic Neck Pain	Change from baseline in NDI at 12 month (follow-up)	Yes
Secondary	Short Form 12	General Health State Questionnaire	pre and post intervention and 6 and 12 months of follow up	Yes
Secondary	EuroQoL 5 Dimensions	Health Related Quality of Life Questionnaire	pre and post intervention and 6 and 12 months of follow up	Yes