NCT02046876

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

5 months

First QC Date

December 24, 2013

Last Update Submit

January 24, 2014

Conditions

Keywords

neck painphysiotherapyadapted swimmingtherapeutic exerciseshealth education

Outcome Measures

Primary Outcomes (3)

  • Neck Disability Index

    Disability due to Chonic Neck Pain

    Change from baseline in NDI at 8 weeks (post-treatment)

  • Neck Disability Index

    Disability due to Chonic Neck Pain

    Change from baseline in NDI at 6 month (follow-up)

  • Neck Disability Index

    Disability due to Chonic Neck Pain

    Change from baseline in NDI at 12 month (follow-up)

Secondary Outcomes (2)

  • Short Form 12

    pre and post intervention and 6 and 12 months of follow up

  • EuroQoL 5 Dimensions

    pre and post intervention and 6 and 12 months of follow up

Study Arms (1)

Multimodal Physiotherapy Program for Chronic Neck Pain Suffers

EXPERIMENTAL
Other: Multimodal Physiotherapy Program

Interventions

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

Multimodal Physiotherapy Program for Chronic Neck Pain Suffers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patronato Municipal de Deportes de Torremolinos

Torremolinos, Málaga, 29620, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Neck PainHealth Education

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Antonio I Cuesta-Vargas, PhD

    University of Malaga and Faculty of Health at the Queensland University of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 24, 2013

First Posted

January 28, 2014

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations