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

January 24, 2014 updated by: Dr. Antonio I Cuesta-Vargas, University of Malaga

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Málaga
      • Torremolinos, Málaga, Spain, 29620
        • Patronato Municipal de deportes de Torremolinos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multimodal Physiotherapy Program for Chronic Neck Pain Suffers
Other: Multimodal Physiotherapy Program
Multimodal Physiotherapy Program integrates: physical land-based therapeutic exercise, adapted swimming and health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Disability Index
Time Frame: Change from baseline in NDI at 8 weeks (post-treatment)
Disability due to Chonic Neck Pain
Change from baseline in NDI at 8 weeks (post-treatment)
Neck Disability Index
Time Frame: Change from baseline in NDI at 6 month (follow-up)
Disability due to Chonic Neck Pain
Change from baseline in NDI at 6 month (follow-up)
Neck Disability Index
Time Frame: Change from baseline in NDI at 12 month (follow-up)
Disability due to Chonic Neck Pain
Change from baseline in NDI at 12 month (follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form 12
Time Frame: pre and post intervention and 6 and 12 months of follow up
General Health State Questionnaire
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
Health Related Quality of Life Questionnaire
pre and post intervention and 6 and 12 months of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaga

Investigators

  • Principal Investigator: Antonio I Cuesta-Vargas, PhD, University of Malaga and Faculty of Health at the Queensland University of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 24, 2013

First Submitted That Met QC Criteria

January 24, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Estimate)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 24, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMA-1301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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