NCT01431261

Brief Summary

The purpose of this study is to test whether a physiotherapy intervention containing pain management, general training and specific neck exercises can improve function for patients with chronic neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 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

First Submitted

Initial submission to the registry

August 30, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 9, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

4.4 years

First QC Date

August 30, 2011

Last Update Submit

October 6, 2016

Conditions

Neck PainChronic Pain Syndrome

Keywords

Chronic neck painWhiplashWhiplash Associated DisordersChronic PainNeck exercisesTrainingPacingPatient EducationPain ManagementWhiplash InjuriesMusculoskeletal

Outcome Measures

Primary Outcomes (1)

  • Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS)

    12 months

Secondary Outcomes (11)

  • craniocervical flexion test

    12 months

  • cervical range of motion

    12 months

  • neck positioning test

    12 months

  • Self-rated measure Global Perceived Effect

    12 months

  • Neck Disability Index

    12 months

  • +6 more secondary outcomes

Study Arms (2)

Pain Management + Training

ACTIVE COMPARATOR

Education in pain management strategies and treatment sessions including instructions in neck exercises and aerobic training

Other: Education and training

Pain Management

ACTIVE COMPARATOR

Education in pain management strategies

Behavioral: Pain management

Interventions

Education and trainingOTHER

Educational sessions in pain management 4 times and treatment sessions including instructions in training and specific exercises 8 times

Pain Management + Training
Pain managementBEHAVIORAL

Educational sessions in pain management 4 times

Pain Management

Eligibility Criteria

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

You may qualify if:

  • chronic neck pain for at least 6 months
  • reduced physical neck function (NDI minimum 10)
  • pain primarily in the neck region,
  • finished any medical /radiological examinations
  • able to read and understand Danish and
  • able to participate in the exercise program.

You may not qualify if:

  • radiculopathies upper extremity
  • neurological deficits
  • in a process of examining for unknown pathology,
  • experimental medical treatment,
  • being in a unstable social situation
  • pregnancy
  • fractures
  • suffering from depression
  • other known coexisting medical conditions which would severely restrict participation in the exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark, Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics

Odense, 5230, Denmark

Location

Related Publications (3)

  • Ris I, Juul-Kristensen B, Boyle E, Kongsted A, Manniche C, Sogaard K. Chronic neck pain patients with traumatic or non-traumatic onset: Differences in characteristics. A cross-sectional study. Scand J Pain. 2017 Jan;14:1-8. doi: 10.1016/j.sjpain.2016.08.008. Epub 2016 Oct 12.

    PMID: 28850421DERIVED

  • Ris I, Sogaard K, Gram B, Agerbo K, Boyle E, Juul-Kristensen B. Does a combination of physical training, specific exercises and pain education improve health-related quality of life in patients with chronic neck pain? A randomised control trial with a 4-month follow up. Man Ther. 2016 Dec;26:132-140. doi: 10.1016/j.math.2016.08.004. Epub 2016 Aug 20.

    PMID: 27598552DERIVED

  • Hansen IR, Sogaard K, Christensen R, Thomsen B, Manniche C, Juul-Kristensen B. Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: design of a randomised controlled trial. BMC Musculoskelet Disord. 2011 Dec 2;12:274. doi: 10.1186/1471-2474-12-274.

    PMID: 22136113DERIVED

Related Links

MeSH Terms

Conditions

Neck PainWhiplash InjuriesChronic PainAgnosia

Interventions

Educational StatusPain Management

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeck InjuriesWounds and InjuriesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsTherapeuticsDisease ManagementPatient Care ManagementHealth Services Administration

Study Officials

  • Birgit Juul-Kristensen, ph.d.

    University of Southern Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. student

Study Record Dates

First Submitted

August 30, 2011

First Posted

September 9, 2011

Study Start

January 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 7, 2016

Record last verified: 2016-10

Locations

DK(1)