Swimming Adapted, Therapeutic Exercise and Health Education in the Treatment of Chronic Neck Pain
Primary Purpose
Chronic Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multimodal Physiotherapy Program
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Neck Pain focused on measuring neck pain, physiotherapy, adapted swimming, therapeutic exercises, health education
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.
Sites / Locations
- Patronato Municipal de Deportes de Torremolinos
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multimodal Physiotherapy Program for Chronic Neck Pain Suffers
Arm Description
Outcomes
Primary Outcome Measures
Neck Disability Index
Disability due to Chonic Neck Pain
Neck Disability Index
Disability due to Chonic Neck Pain
Neck Disability Index
Disability due to Chonic Neck Pain
Secondary Outcome Measures
Short Form 12
General Health State Questionnaire
EuroQoL 5 Dimensions
Health Related Quality of Life Questionnaire
Full Information
NCT ID
NCT02046876
First Posted
December 24, 2013
Last Updated
January 24, 2014
Sponsor
University of Malaga
1. Study Identification
Unique Protocol Identification Number
NCT02046876
Brief Title
Swimming Adapted, Therapeutic Exercise and Health Education in the Treatment of Chronic Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
neck pain, physiotherapy, adapted swimming, therapeutic exercises, health education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
N/A
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multimodal Physiotherapy Program for Chronic Neck Pain Suffers
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Multimodal Physiotherapy Program
Intervention Description
Multimodal Physiotherapy Program integrates: physical land-based therapeutic exercise, adapted swimming and health education
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
Disability due to Chonic Neck Pain
Time Frame
Change from baseline in NDI at 8 weeks (post-treatment)
Title
Neck Disability Index
Description
Disability due to Chonic Neck Pain
Time Frame
Change from baseline in NDI at 6 month (follow-up)
Title
Neck Disability Index
Description
Disability due to Chonic Neck Pain
Time Frame
Change from baseline in NDI at 12 month (follow-up)
Secondary Outcome Measure Information:
Title
Short Form 12
Description
General Health State Questionnaire
Time Frame
pre and post intervention and 6 and 12 months of follow up
Title
EuroQoL 5 Dimensions
Description
Health Related Quality of Life Questionnaire
Time Frame
pre and post intervention and 6 and 12 months of follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio I Cuesta-Vargas, PhD
Organizational Affiliation
University of Malaga and Faculty of Health at the Queensland University of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Patronato Municipal de Deportes de Torremolinos
City
Torremolinos
State/Province
Málaga
ZIP/Postal Code
29620
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
25710539
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.
Results Reference
derived
Learn more about this trial
Swimming Adapted, Therapeutic Exercise and Health Education in the Treatment of Chronic Neck Pain
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